Business
Ensysce Biosciences Provides Mid-Year 2024 Update
~ Ready to Commence PF614 Phase 3 Clinical Trial in 2024 ~~ Continued Clinical Development of Overdose Protection Breakthrough Therapy ~~ Identified Lead
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Ready to Commence PF614 Phase 3 Clinical Trial in 2024 ~~ Continued Clinical Development of Overdose Protection Breakthrough Therapy ~~ Identified Lead Clinical Candidate for Opioid Use Disorder Program ~ SAN DIEGO, CA / ACCESSWIRE / July 23, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) (\"Ensysce\" or the \"Company\"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today provides a Company review and update on a successful first half of 2024, including achievement of Breakthrough Therapy designation from the U.S. Food & Drug Administration (FDA).Recent clinical and development highlights:PF614:Successfully completed a PF614 End of Phase 2 meeting with the FDA, which provided guidance on strategy and design of the Phase 3 clinical program.Published the results of clinical study P614-102, which determined that PF614 was bioequivalent to OxyContin, potentially allowing it to be developed through the shortened FDA 505(b)(2) regulatory pathway. The results were published in an article entitled ‘Clinical evaluation of PF614, a novel TAAPä prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers'.Established manufacturing partnerships with Societal CDMO, Porton Pharma Solutions, and Purisys LLC to position Ensysce for commercial scale production of PF614.PF614-MPAR:The FDA granted Breakthrough Therapy designation to PF614-MPAR, specifically acknowledging the potential impact of the innovative MPAR® overdose protection technology. Breakthrough Therapy is an elite designation that expedites the development and review of drugs that are intended to treat a serious condition where the drug may demonstrate substantial improvement over available therapies.Applied for an additional $15 million non-dilutive grant funding from National Institutes of Health (NIH) and National Institute on Drug Abuse (NIDA) to support three years of continued development for PF614-MPAR with a potential start date in the third quarter of 2024.Presented the clinical data for PF614-MPAR that resulted in the granting of Breakthrough Therapy designation at the NIH annual HEAL (Helping End Addiction Long term) meeting, and the PF614-MPAR platform was recognized in the Trailblazer Session presented...