PainReform Reaches 50% Enrollment in the Second Part of its Phase 3 Clinical Trial of PRF-110 in Bunionectomy
April 02 2024 - 8:30AM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, today announced it has reached the 50% enrollment
target for the second part of Phase 3 clinical trial of PRF-110 in
bunionectomy. In total, over 200 patients have been enrolled, of up
to approximately 400 patients at eight clinical sites across the
U.S.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “I am thrilled to announce that we have hit a
critical milestone in our Phase 3 clinical trial of PRF-110 for
bunionectomy, with 50% of the required participants now enrolled.
Importantly, to date there have been no reported serious adverse
events, underscoring PRF-110’s potential safety gathered until
today. We're on track to wrap up enrollment on schedule and are
looking forward to sharing the early results in Q3 2024. We remain
highly encouraged by the potential of PRF-110 to redefine the
standard of care in the multibillion-dollar postoperative pain
management market, as well as offering patients a compelling
alternative to systemic opioids, which have contributed to the
global opioid epidemic.”
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.
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Statements
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with respect to objectives, plans and strategies and expected
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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 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; and statements as to the impact of the
political and security situation in Israel on our business,
including due to the current war between Israel and Hamas. 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, LLCTel: 212-671-1021Email:
prfx@crescendo-ir.com
Ilan HadarChief Executive OfficerPainReform
Ltd.Tel: +972-54-5331725Email: ihadar@painreform.com
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