Ensysce Biosciences Announces Key Efficacy Data for Lead Analgesic

Results Reinforce Efficacy of PF614 as a Next Generation Analgesic with Significant Pain Intensity Reduction PF614 Clinical Data Primes FDA Evaluation and Design of Phase 3 Studies in 2024

Ensysce Biosciences, Inc., a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that its most recent study has demonstrated crucially important data for PF614 on pain intensity efficacy and speed of onset.

The PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects', which completed enrollment in November 2023, demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels, the first ever measured for this TAAP opioid. The study endpoints matched all previous clinical studies, demonstrating that Ensysce's TAAP chemical approach delivers strong analgesia safely and effectively. This ‘time of onset' study data supports the key elements of our Phase 3 study designs that will allow the Company to affirm its Phase 3 plans and launch strategy for PF614 with the FDA during its End of Phase 2 meeting scheduled in late January 2024.

Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "This study met its primary goal and successfully demonstrated the efficacy for PF614 using a well-established, validated experimental pain model in healthy subjects. We are exceptionally pleased that the measurement of oxycodone blood levels from four earlier studies fully matched the efficacy measured in this Phase 2 study. We believe the insights we've gained regarding the efficacy of PF614 as well as its safety, make us exceptionally positioned to move to the next stage of development for this new class of agents to treat severe pain."

Dr. Lynn Kirkpatrick, CEO of Ensysce, offered, "The successful completion of this study is critical to maintain the progress and development of our lead analgesic, PF614. Today's announced data builds on that from our prior bioequivalence study and shows strong efficacy in pain intensity reduction. The additional benefits of PF614's analgesic properties identified in prior clinical studies align with our target profile. We believe PF614 is the first abuse protective opioid with longer lasting genuine twice daily dosing, which experts describe as a potential revolutionary treatment for severe pain."

Published on : 22nd December, 2023