Full Press Release Details
PainReform Highlights Surgical Advantages
Studies demonstrate unique benefits of
PRF-100 beyond analgesic activity
PRF-110 addresses potential concerns
in the local administration of anesthetic related to wound healing and suture integrity
that are commonly involved in surgical
HERZLIYA, Israel - October 19,
2020 - PainReform Ltd. (NasdaqCM: PRFX) ("PainReform" or the "Company"), a clinical stage specialty
pharmaceutical company focused on the reformulation of established therapeutics, today provided an update on the reported surgical
benefits of PRF-110. The studies address potential concerns that local administration of anesthetic might have negative effects
on wound healing and suture integrity. These benefits are in addition to the previously reported clinical benefits observed in
prior trials, which included up to 72 hours of post-operative pain reduction and no reported serious adverse events.
PRF-110, the Company's lead drug
candidate, is based on the local anesthetic ropivacaine, targeting the post-operative 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
post-operative analgesia. The company is now advancing PRF-110 into Phase 3 pivotal studies in bunionectomy and hernia repair.
Key surgical benefits observed to date,
These benefits were observed in two studies-one
on sutures and surgical mesh in the presence of PRF110 and one for the healed tissue tensile strength. In the first study, "Assessment
of the Effect of PRF-110 on the Mechanical Surgical Meshes and Surgical Sutures," no statistically significant difference
was found between the mechanical properties (breaking force and elongation) for either sutures or surgical meshes in the non-treated
versus the PRF-110 treated groups.
In the second study, "Potential Effects
Assessment of Local Anesthetic PRF-110 on Wound Healing in Domestic Swine," the objective of the study was to evaluate and
compare the potential effects of PRF-110 and ropivacaine on the healing of a full-thickness skin wound that extends into the underlying
muscle in pigs. The study results suggest that PRF-110 does not have a detrimental effect on the mechanical properties of healed
incision 14 days post-surgery based on the comparison.
Dr. Ehud Geller, Chairman of the Board,
commented, "We believe PRF-110 offers significant advantages over systemic administration of pain medications, which we believe
has significantly contributed to the opioid epidemic. Moreover, while other companies have pursued local administration of anesthetics,
these approaches have raised concerns with the FDA regarding post-surgical product safety in general and, specifically, potential
deviations from normal post-surgical wound healing. In contrast, PainReform conducted extensive studies with its lead compound
PRF-110 to deal with various aspects of wound healing and its related safety aspects. One of the major advantages of PRF-110 is
that in addition to ropivacaine, a well-known and safe drug, it is composed entirely of materials that have been designated by
the FDA as Generally Regarded as Safe (GRAS), thereby significantly reducing the likelihood of untoward local tissue reactions.
We believe these studies validate unique and important aspects of our approach beyond analgesic activity, as it relates to the
anticipated performance of PRF-100 in addressing challenging physical and wound healing requirements."
"Given both the localized and extended
pain relief demonstrated in our prior clinical trials, up to 72 hours of substantial post-operative pain relief, combined with
the demonstrated safety and wound healing advantages versus competing products, assuming our Phase 3 trial is successful, we believe
PRF-110 has the potential to become standard-of-care within the $12 billion post-operative pain treatment market (Persistence Market
Research, 2018). Importantly, we believe the inherent advantages of PRF-110 will contribute to increased uptake and administration
by surgeons as an alternative to systemic pain medication, which we believe will also play an important role in addressing the
global opioid pandemic."
As previously reported, PRF-110 provided
substantial pain reduction for up to 72 hours post-operatively the in the Company's prior Phase 2 proof-of-concept clinical
study in herniorrhaphy (hernia repair). A comparison of these results to historical data for ropivacaine alone suggests a substantial
advantage to using PRF-110 over the local anesthetic, ropivacaine, alone. As indicated in the FDA approved drug description for
ropivacaine, such drug provides pain relief for only 2 to 6 hours. The surgeons that participated in the PRF-110 Phase 2 trial
reported that it was easily integrated into the procedure and non-disruptive of existing surgical techniques. Ropivacaine, the
active drug used in PRF-110, is a safe and well characterized local anesthetic and the other components that make up the remainder
of the PRF-110 formulation are classified as GRAS by the FDA, mitigating many potential safety issues that are common in drug development.
In a phase 1 safety study conducted in Israel, healthy volunteers were treated with subcutaneous PRF-110. In that study no serious
adverse events were noted and PRF-110 showed prolonged pain reduction when the subjects were tested for their responses to mild
or moderate pain stimuli.
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 post-operative 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 post-operative
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.
Notice Regarding Forward-Looking Statements
This press release contains certain
forward-looking statements, including statements with regard to PainReform's proposed clinical trials. Words such as "expects,"
"anticipates" and "intends" or similar expressions are intended to identify forward-looking statements.
These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance
can be given that the clinical trials discussed above will be successfully completed. Completion of the proposed clinical trials
are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, failure of
the clinical trials, and the risk factors and other matters set forth in the Company's recent prospectus included in the
registration statement, in the form last filed with the SEC. PainReform undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Crescendo Communications, LLC
Email: prfx@crescendo-ir.com