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VASCEPA^®, compared with placebo, significantly reduced primary composite first and total
major adverse cardiovascular events (
MACE
)
in post hoc exploratory analyses of patients with a history of
CABG
by
2
4% and 3
6
%, respectively, and key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 3
1
%

Administration of VASCEPA resulted in robust absolute risk reductions of
6
.
2
% and
6
.
0
% and numbers needed to treat (NNT) of 1
6
and 1
7
, respectively, for both primary and key secondary (hard MACE) composite endpoints
in these subgroup analyses

Amarin to Webcast Discussion of Presented Data
on
November 18
,
2020 at
4:30 p.m., Eastern
Standard
Time

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT^® CABG at American Heart Association’s (AHA) Virtual Scientific Sessions 2020, being held virtually from November 13 – November 17, 2020, adding to the growing body of knowledge on the clinical impact of VASCEPA^® (icosapent ethyl). These new analyses supported by Amarin were presented by Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto.

“The REDUCE-IT CABG analysis results are another piece of the puzzle when looking at the potential use of icosapent ethyl in the procedural setting,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT. “The findings of benefit in at-risk patients with prior CABG are consistent with previously presented data on overall reductions in first and total coronary revascularization events, as well as in patients with prior percutaneous coronary interventions, and further strengthen the case for consideration of icosapent ethyl as an additional intervention for use by physicians to care for this patient population.”

The REDUCE-IT CABG analysis examined 1,837 (22.5%) of the patients enrolled in REDUCE-IT, representing all patients who had undergone a prior coronary artery bypass grafting (CABG) procedure, a common form of surgical intervention to help treat coronary heart disease. Baseline characteristics were similar among patients randomized to VASCEPA versus placebo. Post hoc exploratory analyses of this subgroup showed that, for the composite endpoint of 5-point MACE, which was the prespecified primary endpoint for the full REDUCE-IT study cohort, time to first event was significantly reduced with VASCEPA versus placebo by 24% (p=0.004) and total (first and subsequent) events were also reduced by 36% (p=0.0002). For the REDUCE-IT study’s key secondary composite endpoint of 3-point MACE, time to first event was reduced by 31% (p=0.001) in the subgroup of patients with a prior CABG.

Coronary revascularization procedures, such as CABG, are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, inevitably result in additional time spent in a healthcare setting. The latest statistical update from the American Heart Association (AHA) shows that, in 2014, an estimated 371,000 inpatient CABG procedures were performed in the United States with a mean inpatient hospital charge for CABG of $168,541.¹

“Revascularization procedures overall significantly impact the healthcare system, with CABG procedures adding to the burden and driving substantial costs,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “The subgroup data presented at AHA Virtual Scientific Sessions 2020 suggests another way in which VASCEPA can possibly alleviate the significant burden that at-risk patients and the healthcare system face with CABG procedures and how VASCEPA therapy can potentially reduce the risk of dangerous subsequent events.”  

REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, therefore p-values presented for these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization.

These REDUCE-IT CABG results follow multiple scientific presentations of analysis results from other important patient subgroups in the REDUCE-IT study, including REDUCE-IT REVASC² and REDUCE-IT PCI. References to these other subgroup analyses are available on Amarin’s website at www.amarincorp.com.

Additional information on AHA Virtual Scientific Sessions 2020 can be found here.

Audio Webcast Information
Amarin will host an audio webcast on November 18, 2020, at 4:30 p.m. EST to discuss this and other VASCEPA-related information presented during the AHA Virtual Scientific Sessions 2020. To listen please register here, listen live on the investor relations section of the company’s website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within the United States, 201-689-8033 from outside the United States.

About Amarin
Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA^® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. VASCEPA is not yet approved and available in any other countries. Amarin, on its own or together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, Europe and the Middle East. For more information about Amarin, visit www.amarincorp.com.

About Cardiovascular Risk

The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.¹ In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.³ Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.^4,5,6

About REDUCE-IT^®

REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.⁷ The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.⁸ The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.⁹ These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

About
VASCEPA

^®

(icosapent ethyl) Capsules

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.

Indications and Limitation of Use

VASCEPA is indicated:

• As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
  • established cardiovascular disease or
  • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
• As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

• VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
• VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
• It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
• VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
• Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
• Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
• Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
• Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

Effect of
VASCEPA
on Time to First Occurrence of Cardiovascular Events in Patients with

Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

FULL
VASCEPA

PRESCRIBING INFORMATION

CAN BE FOUND AT

WWW.


VASCEPA


.COM

.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential impact of VASCEPA in various clinical uses. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information

Investor Inquiries:

Investor Relations
In U.S.: +1 (908) 719-1315
Amarin Corporation plc
[email protected] (investor inquiries)

Solebury Trout
[email protected]

Media Inquiries:

Alina Kolomeyer
Communications
Amarin Corporation plc
In U.S.: +1 (908) 892-2028
[email protected] (media inquiries)

_____________________________
¹  American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.
²  Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Reduction in Revascularization with Icosapent Ethyl: Insights from REDUCE-IT REVASC. Circulation. 2020 Nov 5. doi: 10.1161/CIRCULATIONAHA.120.050276. Epub ahead of print. PMID: 33148016.
³  Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
⁴  Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
⁵  Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
⁶  Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
⁷  Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
⁸  Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
⁹  Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.

ECHO
Data
from EXPLORER-HCM
Show
Mavacamten
Treatment Improved Cardiac Structure and Mitral Valve Function in
Obstructive Hypertrophic Cardiomyopathy Patients

Markers of Physical Activity from
MAVERICK-HCM
Accelerometry Data Correlated
with
M
arkers of HCM S
everity
in Non-Obstructive HCM

Non-Clinical Data
Show
Mavacamten
Surrogate Preserved Cardiac Function in Disease Model, Slowing Progression

BRISBANE, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today presented clinical and non-clinical data related to mavacamten, MyoKardia’s investigative therapeutic in late-stage development for the potential treatment of hypertrophic cardiomyopathy (HCM), at the American Heart Association’s Scientific Sessions 2020. Three poster presentations were made available detailing exploratory analyses from Myokardia’s Phase 3 EXPLORER-HCM study of mavacamten for the treatment of obstructive HCM and from the Phase 2 MAVERICK-HCM study of mavacamten in patients with non-obstructive HCM, as well as non-clinical results of a mavacamten surrogate compound in a large animal model.

“These data add detail to the emerging picture of mavacamten’s beneficial impact on the HCM heart, including improvements in cardiac pathophysiology, diastolic function and biomarkers of disease progression,” said Jay Edelberg, M.D., Ph.D., MyoKardia’s Chief Medical Officer. “HCM is characterized by the thickening of the heart muscle and constraints on diastolic filling. Having repeatedly demonstrated that mavacamten can have a profound effect on reducing the obstruction of the left ventricular outflow tract in HCM, echocardiography data from our EXPLORER-HCM trial show that in just 30 weeks of treatment, mavacamten is gradually bringing measures of cardiac structure closer to a normal state, improving parameters of diastolic function and reducing biomarkers of disease. We are optimistic that these changes may ultimately point to the benefits of mavacamten treatment in the progression of HCM.”

Mavacamten Favorably Impacts Key Pathophysiologic Processes in Obstructive Hypertrophic Cardiomyopathy: Results From the EXPLORER-HCM Study

An exploratory analysis from the Phase 3 EXPLORER-HCM clinical trial of mavacamten for the potential treatment of symptomatic, obstructive HCM investigated the changes from baseline to Week 30 on specific measures of the heart’s structure and function using serial echocardiograms (ultrasounds of the heart).

• Treatment with mavacamten led to statistically significant reductions in left ventricular mass (LVMI), indicating that mavacamten is having an effect on cardiac structure. LVMI has been shown to be a predictor of HCM-related mortality.
• Mavacamten treatment improved left ventricular relaxation (which in turn led to improved cardiac filling pressures). Statistically significant improvements (p<0.0001 for difference from placebo) were achieved across diverse echocardiographic measurements of diastolic function (LA volume index, lateral e’, lateral E/e’, septal e’, and septal E/e’).
• Significantly more mavacamten-treated patients achieved resolution of mitral valve systolic anterior motion (SAM) compared to placebo (80.9% vs. 34.0%; p<0.0001), and 9% achieved resolution of mitral regurgitation (MR) in the mavacamten group vs. none in placebo (p=0.0006). SAM and MR may cause or contribute to obstruction of the left ventricular outflow tract and are known to impact cardiac performance and increase risk of serious cardiovascular complications, such as arrhythmias.
• Mavacamten treatment resulted in significant reductions in cardiac biomarkers of myocardial wall stress and injury compared to placebo. Specifically, there was an 80% greater reduction in NT-proBNP and a 41% greater reduction in cardiac troponin in the mavacamten treatment group vs. placebo.
• Patients with the highest degree of obstruction at baseline achieved greater improvements in echocardiographic parameters and biomarker reductions.

Accelerometer-measured Activity in Non-obstructive Hypertrophic Cardiomyopathy: Patient-generated Activity Measures Correlate With, and are Convolutional Neural Network Predictors of, Clinical Parameters in the MAVERICK-HCM Study

MyoKardia’s Phase 2 MAVERICK-HCM study of mavacamten was the first study to examine quantitative levels of activity in a non-obstructive HCM patient population. As part of the MAVERICK-HCM study, patients were asked to wear ActiGraph GT9X Link wrist-worn monitors for up to 14 days between screening and day 1 and between weeks 12 and 16 to record daily activity. A multitask convolutional neural network (CNN) trained on raw accelerometry, was also used to jointly predict clinical markers of HCM severity.

Markers of physical activity drawn from accelerometry, including average daily accelerometer units (ADAUs) and step count, were associated with standard clinical markers of HCM severity. Out the 59 patients enrolled in MAVERICK-HCM, 50 patients wore the accelerometer for ≥1 compliant day. Patients in MAVERICK-HCM averaged 3,000 steps per day. Results from the accelerometry exploratory analyses showed that higher physical activity correlated with key clinical markers of HCM, including exercise capacity as measured by peak VO2, changes in NT-proBNP levels, and improvements in patient reported outcomes using the Kansas City Cardiomyopathy Questionnaire (KCCQ), indicating that accelerometry measures may be a useful indicator of drug activity. CNN predictions of clinical measures from activity data found strong correlations for pVO₂, NT-proBNP, KCCQ score, and E over e prime. These findings indicate that deep learning models can be constructed to predict markers of HCM severity from patients’ raw accelerometry data.

Chronic Treatment With A Mavacamten-like Myosin-modulator (MYK-581) Prevents Left-atrial Remodeling, Decreases Cardiac Troponin Leakage, And Blunts Mortality In A Mini-pig Model Of Inherited Hypertrophic Cardiomyopathy

Results from an in vivo study in a genetic mini-pig model of HCM showed that chronic administration of a mavacamten-like myosin-modulator blunted chronic cardiac troponin-T leakage and decreased mortality, both characteristic of HCM progression in this non-obstructive model. In addition, chronic treatment also reduced left-ventricular and prevented left-atrial remodeling, preserving normal left-atrial size as well as atrial myofibrillar structure and function. Taken together, these non-clinical observations provide additional evidence of mavacamten’s activity beyond the reduction of LVOT obstruction and support the emerging clinical evidence of mavacamten’s beneficial effects on overall cardiac structure in the HCM heart.

About
MyoKardia

MyoKardia is a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by 1) understanding the biomechanical underpinnings of disease; 2) targeting the proteins that modulate a given condition; 3) identifying patient populations with shared disease characteristics; and 4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia’s initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the clinical and therapeutic benefit and future potential of mavacamten, the ability of our long-term studies to provide further evidence of mavacamten’s potential to alter the course of disease by gradually brining measures of cardiac structure to a normal state, usefulness of raw accelerometry data to predict markers of HCM severity in patients, and the ability of non-clinical observations to provide additional evidence of mavacamten’s activity beyond the reduction of LVOT obstruction, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the development and regulation of our product candidates and any ongoing effects of the COVID-19 pandemic, as well as those set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and our other filings with the SEC. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Michelle Corral
Executive Director, Corporate Communications and Investor Relations
MyoKardia, Inc.
650-351-4690
[email protected]

Hannah Deresiewicz (investors)
Stern Investor Relations, Inc.
212-362-1200
[email protected]

Julie Normant (media)
W2O
628-213-3754
[email protected]

IRVINE, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced follow-up results of the first 230 patients enrolled in its FLASH study.  FLASH is a real world registry to study the FlowTriever system in intermediate- and high-risk pulmonary embolism (“PE”) patients.  The results were strongly positive.  Just one death (0.4%) was reported at 30 days.  By contrast, the national PERT Consortium^® Quality Database recently showed 30-day mortality rates of 25.9% and 6.1% for high- and intermediate-risk PE patients.  In addition, the FLASH Registry showed a readmission rate of 6.7%, compared to the nearly 25% readmission rate shown in the PERT Database.  Efficacy data were equally compelling, showing normalization or near normalization in a battery of hemodynamic variables like pulmonary artery pressure, RV/LV ratio, and heart rate, as well as dyspnea (shortness of breath) metrics.   

FLASH is a 500-patient prospective, multicenter, single-arm registry evaluating real world patient outcomes after treatment of PE with FlowTriever. Interim data were obtained across 19 US sites, and results were presented virtually by National Principal Investigator, Catalin Toma, MD, Director of Interventional Cardiology at UPMC Heart & Vascular Institute in Pittsburgh, PA at the American Heart Association (“AHA”) Scientific Sessions 2020.

These data follow the presentation of equally compelling acute data from the same patient set delivered two weeks ago at the annual TCT meeting.  The acute results showed, at 48 hours, no deaths, no cardiac injuries, no pulmonary injuries, no procedure-related clinical deteriorations, and no intracranial hemorrhages in this highly compromised PE patient population.  The TCT data also showed clinically and statistically significant improvement in hemodynamic parameters while the patient was still on the table.  Post-procedure median ICU stay was 0 days.  The new FLASH data released at AHA extends the study follow-up period to 30 days and demonstrates the durability of these acute results with continued improvement in outcomes over time.

“FLASH has shown us that PE patients experience symptom relief and improved cardiac function immediately upon removal of significant clot burden.  These outcomes continue to improve over time.  In fact, for a high percentage of these patients, measurements for dyspnea, right heart strain, pulmonary artery pressure and heart rate actually normalized after FlowTriever thrombectomy.  We believe this suggests that removal of large clot burden with the FlowTriever system not only has an important impact acutely, but might have an important positive effect on long term implications of PE, like CTED and CTEPH,” said Dr. Toma.

“With over 60% of patients in FLASH having no contraindication to lytics, the study data suggests that FlowTriever is emerging as a frontline therapy for intermediate and high-risk PE patients, regardless of patient eligibility for other treatment options.  PE care pathways are evolving,” said Thomas Tu, MD, Chief Medical Officer of Inari Medical. “Venous thromboembolism (“VTE”) patients are central to everything that we do at Inari, and we remain committed to advancing the treatment of this disease through clinical research and the continued development of purpose-built devices.”

About Inari Medical, Inc.

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally-invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by the FDA for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by the FDA for the treatment of pulmonary embolism.

Investor Contact:

Westwicke Partners
Caroline Corner
Phone +1-415-202-5678
[email protected]

Data Demonstrate Achievement of Rapid Conversion
s
from Atrial Fibrillation to Normal Sinus Rhythm

Study Findings Provide Proof
of
Concept for
First-of-its-Kind Inhaled Antiarrhythmic for Treatment of Paroxysmal Atrial Fibrillation
(PAF)  

Provides Roadmap for
Start of
Pivotal Phase 3 in Medically Supervised Setting in 2021

SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) — InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases today announced the presentation of positive data from the open-label, dose-escalation Part A portion of the company’s multinational INSTANT Phase 2 clinical trial of InRhythm^™ (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF) at the American Heart Association’s (AHA) Scientific Sessions 2020. The positive study results reported today during the AHA conference provide the first proof of concept for inhaled flecainide as a potentially safe and effective therapeutic option for rapidly converting PAF to normal sinus rhythm (NSR).

InRhythm is a novel inhaled therapeutic candidate designed to rapidly deliver flecainide, a well-established antiarrhythmic agent, to the heart via the lungs to restore NSR and to relieve symptoms associated with acute episodes of PAF. The therapy is being developed initially for its use under medical supervision in a hospital, emergency room or physician office and subsequently as a portable treatment that can be self-administered by patients in a non-medically supervised setting (such as the home) to rapidly achieve conversion of PAF to NSR.

Dr. Harry J.G.M. Crijns, professor, chair of cardiology and board member of the Cardiovascular Research Institute Maastricht (CARIM) at Maastricht UMC+, and co-principal investigator of the INSTANT trial, presented data from Part A of the INSTANT trial. The results demonstrated the rapid achievement of therapeutic plasma levels (C_max > 200 ng/mL) of flecainide via oral inhalation with InRhythm. Approximately 80% of patients who received the study’s highest administered dose (120 mg) achieved a flecainide C_max > 200 ng/mL. For all study participants who reached these therapeutic plasma levels, nearly 50 percent achieved a successful conversion from PAF to NSR. Importantly, those successful conversions occurred rapidly, with a median time to conversion of 3.6 minutes after the end of the administration of InRhythm (total inhalation time for InRhythm administration is eight minutes). The treatment was shown to be safe and well tolerated, and the majority of adverse events were transient, mild in severity and resolved without treatment.

“There is growing clinical and scientific evidence to support the importance of rhythm control in the overall management of atrial fibrillation,” said Jeremy N. Ruskin, M.D., professor of medicine at Harvard Medical School and founder and director emeritus of the Cardiac Arrhythmia Service at Massachusetts General Hospital and co-principal investigator of the INSTANT study. “Currently available treatment options for the acute conversion of atrial fibrillation to normal sinus rhythm are limited and do not fully address the unmet needs of improving patients’ symptoms and quality of life and reducing healthcare costs. This novel therapy for rapid restoration of normal rhythm, if successful in pivotal clinical trials, has the potential to play a significant role in addressing these unmet clinical needs.”

Based on these positive study results, InCarda has commenced enrollment of Part B of the INSTANT study which includes a confirmatory cohort using the selected optimal therapeutic dose (120 mg) and a pilot study referred to as the “Patient-led Sub-study.” In this latter study patients who have already experienced a safe cardioversion with InRhythm will receive training so that they can self-administer InRhythm under medical supervision when another (“recurrent”) episode of PAF occurs. In addition to current study sites in the Netherlands and Belgium, InCarda will start recruiting patients in the US later this year.

“The data presented today from the INSTANT study provide the first proof of concept of this novel strategy to deliver flecainide via oral inhalation to rapidly restore NSR in patients with symptomatic episodes of recent-onset PAF. These data will be used to finalize the design of a multinational, Phase 3 trial of InRhythm to support marketing approval for in-hospital, medically supervised use. We expect to initiate this study in the first half of 2021,” said Luiz Belardinelli, M.D., chief medical officer of InCarda.

“With six million atrial fibrillation patients in the US contributing to over $26B in annual healthcare expenditures, and more than 30 million atrial fibrillation patients worldwide, there is a tremendous opportunity for InCarda to uniquely address this important and growing need,” said Grace E. Colon, Ph.D., chief executive officer of InCarda. “We look forward to the next steps in the development of this important new therapy and reporting on several key company milestones over the next year.”

About


Atrial Fibrillation (AF)

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia (abnormal heart rhythm) and is characterized by rapid and irregular heartbeats often resulting in palpitations and other symptoms that can be debilitating. A chronic, progressive condition, AF is estimated to affect six million people in the U.S., with that number expected to double by 2050¹. This expected increase is partially due to the correlation between AF prevalence and an aging population, with approximately 9% of those aged 65 and older affected by the condition¹. AF is associated with significant morbidity and a substantial reduction in quality of life, with the condition potentially resulting in exercise intolerance, congestive heart failure, tachycardia-induced cardiomyopathy and stroke. The annual cost of AF to the U.S. healthcare system is estimated at more than $26 billion¹.

Paroxysmal AF (PAF) is a type of AF in which episodes occur intermittently and resolve spontaneously in fewer than seven days. Approximately 25% of PAF patients progress to the permanent form of AF within five years². Common symptoms of PAF can include racing heartbeat, chest pain or pressure, a fluttering feeling in the chest, weakness, fatigue, dizziness, sweating and lightheadedness. Current treatments for patients with PAF rely upon either chronic administration of oral antiarrhythmic drugs or acute hospital-based procedures such as intravenous drug administration and electrical cardioversion, neither of which fully address the unmet need of patients for a rapid-acting treatment that can be administered whenever an episode of PAF occurs. There are currently no approved treatments that can be patient self-administered whenever an episode of PAF occurs.

About InRhythm



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InRhythm (flecainide for inhalation) is a novel inhaled therapeutic candidate designed to rapidly deliver flecainide, a well-established antiarrhythmic agent, to the heart via the lungs, to restore normal sinus rhythm (NSR) and relieve the patient’s symptoms following the onset of an episode of PAF. InRhythm is intended to address the unmet need for a non-invasive, rapid-acting treatment that can be administered in a medically supervised setting (initial indication) and, ultimately, self-administered by patients anywhere they happen to be, whenever they experience an episode of PAF. Phase 1 clinical results in healthy volunteers demonstrated that InRhythm rapidly and safely delivered flecainide resulting in ECG changes consistent with the potential to restore NSR in patients with PAF. InCarda is currently conducting the INSTANT Phase 2 trial of InRhythm in patients with recent-onset PAF. InRhythm represents a first-in-class, multi-billion dollar global opportunity to address a significant unmet medical need.

About


InCarda Therapeutics

InCarda Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company developing first-of-their-kind inhaled therapies for acute cardiovascular diseases and conditions. The company is leveraging the ability of inhaled therapy to deliver medicine in the “first pass” to cardiac tissue, presenting a small, but effective dose of drug directly to affected regions of the heart. This permits rapid-onset, lower off-target tissue exposure of the drug, lower exposure to cardiac tissue and, more importantly, has the potential to be patient self-administered in a non-medical setting (e.g., home). InCarda employs a de-risked approach by using approved drugs with a long history of efficacy and safety as candidates for the new dosing paradigm via inhalation. The company’s lead development product, InRhythm, is in Phase 2 development to treat acute episodes of PAF, a prevalent atrial arrhythmia. For more information, please visit: www.incardatherapeutics.com.

LinkedIn: https://www.linkedin.com/company/incarda-therapeutics/

Twitter: @InCardaThera

References:

¹

J Am Coll Cardiol. 
2014
 Dec 2;64(21):2305-7

²

Am Heart J. 2005 Mar;149(3):489-96

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) from February 28, 2020 through August 18, 2020. If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 24, 2020 DEADLINE.

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=biomarin-pharmaceutical-inc&id=2428 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=biomarin-pharmaceutical-inc&id=2428

If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 24, 2020 DEADLINE.  A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose, among other things:  differences between the Phase 1/2 and Phase 3 study of valoctocogene roxaparvovec limited the reliability of the Phase 1/2 study to support valoctocogene roxaparvovec’s durability of effect; as a result, it was foreseeable that the U.S. Food and Drug Administration would not approve the Biologics License Application for valoctocogene roxaparvovec without additional data; and as a result, the Company’s public statements were materially false and misleading at all relevant times.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of  Fluidigm Corporation (NASDAQ: FLDM) between February 7, 2019 and November 5, 2019, inclusive. If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 20, 2020 DEADLINE.

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=fluidigm-corporation&id=2433 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=fluidigm-corporation&id=2433

If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 20, 2020 DEADLINE.   A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose, among other things:  Fluidigm was experiencing longer sales cycles; as a result, Fluidigm’s revenue was reasonably likely to decline and Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756