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Ensysce Biosciences Reports Second Quarter 2023 Financial Results
~ Progression Toward Full Phase 3 Evaluation of PF614 with Recently Announced IRB Approval of Key Study Protocol ~SAN DIEGO, CA / ACCESSWIRE / August 11, 2023
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Progression Toward Full Phase 3 Evaluation of PF614 with Recently Announced IRB Approval of Key Study Protocol ~SAN DIEGO, CA / ACCESSWIRE / August 11, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today reported financial results for the second quarter of 2023.Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, \"The recently announced IRB approval of the PF614-201 protocol gives us confidence in the momentum we have achieved to date, bringing us closer to our Phase 3 evaluation of PF614. We believe the unique chemistry we have designed around opioids will ultimately lead to a new generation of pain products to alleviate the suffering of those who experience severe pain. We expect our goal to develop both PF614 and PF614-MPAR and expand the use of our two core technologies will be advanced by the recently announced engagement of Alacrita Consulting to explore partnering and licensing opportunities.\"TAAPTM (Opioid Abuse Deterrent Program) UpdatesOur lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential ‘next generation' analgesic for severe pain. The Company's TAAPTM technology is designed to control release, be highly resistant to tampering and reduce abuse through a unique chemical modification. PF614's TAAPTM modification makes it inactive until it is swallowed, following which it is activated or ‘turned on' to release oxycodone by the body's owntrypsin, an enzyme in the small intestine. Ensysce completed three clinical trials over the last year and believes it has a body of evidence showing that PF614 works as designed, is bioequivalent to OxyContin and has a good safety profile. Our most recent studies demonstrate that PF614 is less liked by recreational drug users when taken orally as compared to regular oxycodone, so we believe it is less likely to be abused.Most recently, on August 8, 2023, the Company announced the Investigational Review Board (\"IRB\") approval of the PF614-201 protocol, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects.' This represents yet another key milestone for PF614 in its development pathway. Th...