Business
PainReform Provides Business Update for the Second Quarter of 2023
Targeting to commence second part of Phase 3 clinical trial in bunionectomy during the fourth quarter of 2023 TEL AVIV, Israel, Aug. 10, 2023 (GLOBE NEWSWIRE)
About this update from Prf Technologies Ltd.
[{"type":"text","content":"Targeting to commence second part of Phase 3 clinical trial in bunionectomy during the fourth quarter of 2023\nTEL AVIV, Israel, Aug. 10, 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 second quarter ended June 30, 2023. Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are pleased to report continued progress advancing PRF-110, our lead drug candidate for post-operative extended pain relief, thereby reducing the potential need for the use of opiates. Most notably, we announced positive pharmacokinetic (PK) data in the first part of our two-part Phase 3 clinical trial of PRF-110 in bunionectomy. We are encouraged by this data, which exceeded the FDA safety requirements.” “Since we encountered issues in manufacturing due to circumstances outside our control, it resulted in a delay in the commencement of the second part of the Phase 3 trial. We have worked closely with our API (active pharmaceutical ingredient) supplier to resolve their deficiency notice. As a result, we are hopeful that the second part of our Phase 3 trial will commence in the fourth quarter of 2023. The upcoming second part of the trial will be a double-blind study, randomizing approximately 400 patients at seven clinical sites in the U.S. and measuring pain reduction by PRF-110 over 72 hours compared with placebo and plain ropivacaine.” “We remain confident of the safety and quality of our product as an alternative to systemic opioids. Moreover, we remain highly encouraged by the outlook for the program given the positive PK data in the first part of our Phase 3 trial, as well the favorable results of our prior Phase 2 data in hernia repair. For these reasons, we believe PRF-110 holds enormous potential in the multi-billion postoperative pain market with the potential to become standard of care.” Financial Results for Six Months Ended June 30, 2023 Research and development expenses were $2.7 million for the six months ended June 30, 2023, compared to $1.4 million for the six months ended June 30, 2022, an increase of $1.3 million. The increase was primarily due to an increase in clinical trials costs and manufacturing costs. General and administrative expen...