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.
