PainReform Provides Further Update on Phase 3 Clinical Trial of PRF-110
28 December 2024 - 12:30AM
PainReform Ltd. (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
PainReformPainReform 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.
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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: 212-671-1021Email: prfx@crescendo-ir.com
Dr. Ehud GellerChairman and interim Chief Executive Officer
PainReform Ltd.Tel: +972-54-4236711Email: egeller@medicavp.com
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