TEL AVIV, Israel, Dec. 27, 2024 (GLOBE NEWSWIRE) — PainReformLtd. (Nasdaq: PRFX) (“PainReform” or the “Company“), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.
PainReform previously disclosed initial topline data from its Phase 3 clinical trial in which it reported that it demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery. Yet, at that time, data pertaining to the last 24-hour period of the 72-hour study follow-up was unclear, and efforts were made to resolve the incoherence and complete the analysis.
Following further investigation, PainReform has determined that the data from the final 24-hour period could not be clarified to satisfy the study’s primary endpoint 72 hours requirement, and therefore, it did not meet the primary endpoint of the study. Despite this setback, the Company has initiated research and development (R&D) activities to better understand and refine the pharmaco-kinetics and pharmaco-dynamics of PRF-110 based on the data received from the study. These efforts are intended to potentially resolve this issue to support future clinical trials.
“We are focused on resolving the issue of the last 24 of the 72-hour requirement through the use of high-level, in-vitro models prior to any additional clinical work,” said Dr. Ehud Geller, Chairman and interim CEO of PainReform. “This update reflects our determination to leverage these learnings and continue our mission to provide effective pain relief solutions for surgical patients. Our ongoing R&D efforts aim to deepen our understanding of PRF-110’s profile and enhance its potential in future evaluations. In parallel, we are reviewing our strategic options. There can be no assurance that our review will result in any transaction or that it will enhance shareholder value.”
About
PainReform
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company’s lead product is based on the local anesthetic ropivacaine, targeting the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended postoperative analgesia. The Company’s proprietary extended- release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. For more information, please visit www.painreform.com.
Notice
Regarding
Forward-Looking
Statements
This press release contains forward-looking statements about our expectations, beliefs and intentions including with respect to objectives, plans and strategies and expected timing of
results. Forward-looking statements
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as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”,
“project”,
“forecast”,
“continue”
or
“anticipate”
or
their
negatives
or
variations
of
these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current
conditions,
expected
future
developments
and
other
factors
believed
to
be
appropriate. Forward-looking
statements in
this press release
are
made as
of
the
date
of
this
press
release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future
performance
and
are
subject
to
risks
and
uncertainties,
many
of
which
are
outside
of
our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the
following:
our
ability
to
identify,
evaluate
and
complete
any
strategic
alternative
that
yields value
for
our
shareholders,
our
ability
to
continue
as
a
going
concern,
our
history
of
significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110
and
future
product candidates;
our
limited
experience
managing
clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition
and
new
technologies;
our
ability
to
comply
with
regulatory
requirements
relating to the development and marketing of our product candidates;
our ability to establish and maintain
strategic
partnerships
and
other
corporate
collaborations;
the
implementation
of
our business model and strategic plans for our business and product candidates; the scope of protection
we
are
able
to
establish
and
maintain
for
intellectual
property
rights
and
our
ability to
operate
our
business
without
infringing
the
intellectual
property
rights
of
others;
the
overall global
economic
environment;
our
ability
to
develop
an
active
trading
market
for
our
ordinary shares
and
whether
the
market
price
of our
ordinary
shares
is
volatile; our
ability
to
maintain our listing on the Nasdaq Capital
Market; and statements as
to
the impact of the political and security situation in Israel on our business, including due to the current war in Israel. More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: [email protected]
