PainReform announces plans to commence second part of Phase 3 trial of PRF-110

PainReform 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 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 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. 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