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Ensysce Biosciences Announces IRB Approval for Key MPAR Study
Next Clinical Trial of FDA Breakthrough Therapy PF614-MPAR Supported by $14 Million Federal Government Grant SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 /
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"Next Clinical Trial of FDA Breakthrough Therapy PF614-MPAR Supported by $14 Million Federal Government Grant SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has received Investigational Review Board (\"IRB\") approval of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' Ensysce has continued its collaboration with Quotient Sciences to conduct this second clinical study of MPAR using their Translational Pharmaceutics® platform.Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, \"The approval of this study protocol represents another key milestone towards completing the clinical development of our first-in-class opioid with both abuse and overdose protection. Clinical data from our initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA designation of Breakthrough Therapy. PF614-MPAR is the only opioid to receive such recognition and one of only ~300 drugs ever approved for this designation. We remain dedicated to bringing to market a new generation of safer products to alleviate the suffering of those who experience severe pain.\"Dr. Lynn Kirkpatrick, CEO of Ensysce, offered, \"We are pleased to have IRB approval that allows us to quickly start this second clinical study of PF614-MPAR. This program not only has FDA support but is also supported by the National Institute on Drug Abuse with today's announcement of a $14 million multi-year award to Ensysce. This award allows us to complete this clinical trial and necessary non-clinical studies for both PF614 and the combination with nafamostat. Additionally, the Breakthrough Therapy designation of PF614-MPAR permits frequent interactions with the FDA which are pivotal to maintain a relatively smooth path to registration. We look forward to initiating this three-part trial immediately and expect to announce first data in mid-2025.\"About Ensysce Bioscien...