Ensysce Biosciences ready to commence PF614 Phase 3 trial in 2024

Ensysce Biosciences,provides a Company review and update on the first half of 2024, including achievement of Breakthrough Therapy designation from the U.S. Food & Drug Administration. 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 TAAPa 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 and National Institute on Drug Abuse 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 meeting, and the PF614-MPAR platform was recognized in the Trailblazer Session presented at the 2024 American Association of Pain Medicine annual meeting. Received guidance from the FDA for the efficient execution of the non-clinical program, potentially reducing required costs. Advanced the PF614-MPAR program in a continued collaboration with Quotient Sciences to undertake a second clinical trial, PF614-MPAR-102, anticipated to start in the fourth quarter of 2024. Opioid Use Disorder program: Achieved a major milestone in the Company’s opioid use disorder program with selection of a lead drug candidate. The lead candidate PF9001, a TAAP methadone analogue, has shown lower potential of cardiovascular side effects associated with traditional methadone treatment. The OUD program is supported by non-dilutive grant funding through the Company’s ongoing $15 million multi-year NIDA HEAL award.