PainReform Announces Plans to Commence Second Part of Phase 3 Clinical Trial to Evaluate PRF-110 in Patients Undergoing Bunionectomy Surgery Following Positive FDA Review of Drug Master File
11 Septiembre 2023 - 7:30AM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, today announced plans to commence the second part of
the Company’s phase 3 trial to evaluate PRF-110 in patients
undergoing bunionectomy surgery.
Starting the second part of the bunionectomy
Phase III study follows the clearance by FDA of the DMF (Drug
Master File) held by the Company’s API manufacturer. This second
part of the trial is expected to proceed in the next quarter of
2023.
As announced earlier this year, the company
completed the first part of its Phase 3 clinical trial of PRF-110,
in which 15 patients undergoing bunionectomy surgery were enrolled
at two clinical sites in Texas. The Company reported positive
safety data in the first part of the Phase 3 clinical trial with no
serious adverse events (SAEs) reported, suggesting a substantial
potential advantage to using PRF-110 over opioids. 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).
The upcoming 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 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 comprise the remainder of the PRF-110 formulation
have been designated by the FDA as Generally Recognized as Safe
(GRAS), mitigating many potential safety issues common in drug
development.
Key surgical benefits observed to date
include:
-
PRF-110 does not alter the integrity of standard surgical devices,
such as sutures and meshes used in a large variety of surgical
procedures
-
PRF-110 does not interfere with normal macro and microscopic wound
healing of surgical incisions in soft tissue and bone models
-
PRF-110 does not alter the tensile strength of healed skin at the
surgical sites in an animal study mimicking surgical
procedures
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “We expect to commence the second part of our
phase 3 clinical study in Q4, 2023 following positive
pharmacokinetic (PK) data in the first part of our Phase 3 clinical
trial of PRF-110 in bunionectomy, which exceeded the FDA safety
requirements. This data reinforces the favorable
results of our prior Phase 2 data in hernia repair, which provides
us confidence in the outlook for PRF-110. Although we encountered
delays due to issues experienced by the manufacturer of our API
(active pharmaceutical ingredient), unrelated to PFR-110, we worked
closely with them to rapidly resolve these matters, and our
clinical program is now back on track. following a positive
completion of the DMF review by the FDA. We look forward to
advancing the trial, which we expect to complete and report the
results by mid-2024. Importantly, we believe PRF-110 has the
potential to address a significant unmet need in the multi-billion
postoperative pain market with the potential to become standard of
care as an alternative to systemic opioids.”
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
deposited directly into the surgical wound bed before 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
regarding, among other things, its product development efforts,
business, financial condition, results of operations, strategies or
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of forward-looking words such as "believe", "expect", "intend",
"plan", "may", "should", "could", "might", "seek", "target",
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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 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; 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; commercial success and market acceptance
of our product candidates; our ability to establish sales and
marketing capabilities or enter into agreements with third parties
and our reliance on third party distributors and resellers;
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. 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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