Business
PainReform Provides Year-End Business Update; Commences Phase 3 Clinical Trial of PRF-110 in Bunionectomy
TEL AVIV, Israel, March 16, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical
About this update from Prf Technologies Ltd.
[{"type":"text","content":"TEL AVIV, Israel, March 16, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) (\"PainReform\" or the \"Company\"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a business update for the year ended December 31, 2022. Ilan Hadar, Chief Executive Officer, stated, “We are pleased to report a number of important milestones this past year which have helped advance the clinical development of PRF-110, our lead drug candidate, targeting the post-operative extended pain relief market. Most importantly, we announced the commencement of our Phase 3 clinical trial of PRF-110 in bunionectomy, with Lotus Clinical Research serving as our contract research organization (CRO). We are currently focused on conducting the first part of the clinical trial, in which a total of 15 patients will be enrolled in an open-label safety pharmacokinetic (“PK”) study at two clinical sites in Texas, and our goal is to measure peak blood concentration in order to further validate safety of the lead formulation. We expect to announce the PK study results on the first 15 patients in May 2023. Following the confirmation of peak blood levels, the study will proceed to the second, larger part of the clinical trial, in which we plan to randomize approximately 400 patients at up to seven clinical sites in the U.S., and measure pain reduction over 72 hours for PRF-110, our lead drug candidate, compared with placebo and plain ropivacaine. Overall, we remain highly encouraged by the outlook for our Phase 3 clinicals given our prior Phase 2 data in hernia repair. The data demonstrated a strong safety profile and substantial in post-operative pain relief for up to 72 hours, suggesting a substantial advantage to using PRF-110.” “The initiation of the Phase 3 clinical trial follows the implementation of additional enhancements to our manufacturing process for PRF-110 we made to improve the efficiency and scalability of our manufacturing. As a result, we believe we now have a successful manufacturing process to help ensure the highest quality batch production for the Phase 3 trials, as well as support our planned commercial manufacturing of PRF-110.” “On the heels of the bunionectomy trial, we plan to commence our second Phase 3 trial for pain treatment in hernia repair. We believe our propriet...