PainReform Announces Positive Safety Data in First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery
May 01 2023 - 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 positive safety results in the first part of its two-part
Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy
patients at two clinical sites in Texas. PRF-110 was administrated
intra-operatively to validate the lead formulation's safety further
and confirm optimal product instillation in the surgical wound. The
initial results demonstrated a solid safety profile of PRF-110.
Twenty-six adverse events (AEs) were recorded in total, with no
serious adverse events (SAEs) reported. All adverse events were
considered mild, and most were deemed unlikely to be related to
PRF-110. The optimal method of placing the product –
“instillation,” was studied and locked as the method of choice.
The Phase 3 trial is a randomized, double-blind,
placebo- and active-controlled, multicenter study to evaluate the
analgesic efficacy and safety of intra-operative administration of
PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based,
viscous, clear solution that is deposited directly into the
surgical wound bed before closure to provide localized and extended
postoperative analgesia.
Ilan Hadar, Chief Executive Officer of Pain
Reform, stated, “We are pleased to report positive safety data in
the first part of our Phase 3 clinical trial, suggesting a
substantial potential advantage to using PRF-110 over the local
anesthetic, ropivacaine. In addition, the absence of any serious
adverse events marks a significant clinical milestone of our
non-opioid, pain-relieving treatment for postoperative pain.
Importantly, the first part of the trial allowed us to train the
physicians how to best practice the administration of PRF-110 in
advance of the second part of our trial.
“We look forward to presenting the
pharmacokinetic (PK) data on the first 15 patients next month and
then proceeding to the second stage of the Phase 3 trial. Assuming
our Phase 3 trials are successful, we believe PRF-110 has the
potential to become standard-of-care within the estimated $12
billion postoperative pain treatment market as it addresses the
significant unmet need for a long-acting local anesthetic agent to
spare opioid use.”
The forthcoming second part of the trial will be
a double-blind study, in which the Company plans to randomize
approximately 400 patients at seven clinical sites in the U.S.
PRF-110 will be administered intra-operatively, using the
experience gained in the study’s first part, and will be divided
into three cohorts, PRF-110, ropivacaine, and placebo in a 2:2:1
ratio.
As previously reported, PRF-110 provided pain
reduction for up to 72 hours post-operatively in the Company’s
prior Phase 2 proof-of-concept clinical study in herniorrhaphy
(hernia repair). PRF-110 is a highly uniform solution, resulting in
consistent sustained and extended release of the analgesic.
Ropivacaine, the active drug used in PRF-110, is a safe,
well-tolerated, and well-characterized local anesthetic. The other
components that make up the remainder of the PRF-110 formulation
have been designated by the FDA as Generally Recognized as Safe
(GRAS), by the FDA, mitigating many potential safety issues that
are common in drug development.
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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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
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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 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; the impact of the
COVID-19 pandemic on our operations; 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
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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. 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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