Benzinga | Dec 15, 2021 04:10PM EST

Ensysce Biosciences Announces First Patients Enrolled In Phase 1 Study Of PF614-MPAR, Its Unique Technology Platform To Provide Opioid Overdose Protection

Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC, OTC:ENSCW), a clinical-stage biotech company with novel technology platforms that may provide new hope for those in severe pain, today announced that the first patients have been enrolled in the Phase 1 study of PF614-MPARTM, the first product utilizing the Company's MPARTM platform designed to reduce opioid overdose.

Designed to provide safety and pharmacokinetic data on the combination of PF614 and nafamostat, the study 'Single-Dose Study to Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614 Solution is Co-Administered with Nafamostat, as an Immediate-Release Solution and/or Extended-Release (ER) Capsule Formulations in Healthy Subjects', is being conducted by Dr. Maria Bermudez MD, at Quotient Sciences.

PF614-MPARTM is a combination product of Ensysce's PF614, a trypsin-activated abuse protection (TAAP) oxycodone prodrug and nafamostat, a trypsin inhibitor. This combination provides both abuse and overdose protection to the opioid product that the Company believes is unique in the industry. MPARTM is designed to prevent drug overdose by inhibiting the activation of a TAAP prodrug when more than prescribed doses are taken. The MPARTM combination technology is the first platform that the Company expects may prevent all four common methods of abuse -- injecting, chewing, inhaling, and oral overdose.

"The initiation of this study represents a significant step toward minimizing overdoses and deaths from prescription opioids," said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. "Opioid abuse and overdose are causing significant and long-lasting impacts on the quality of life for sufferers and their families."

Dr. Kirkpatrick concluded: "Ensysce's mission is to launch its first-in-class opioids, PF614 and PF614-MPARTM with the intent of providing protection against both abuse and overdose. Drug overdose deaths hit record levels in 2021. With our current clinical study of PF614, a TAAP opioid with abuse protection, progressing through bioequivalence and planned human abuse liability studies, this additional study of PF614-MPARTM with added overdose protection will enhance our dual-prong approach to provide safer solutions to patients and prescribers."

"Enrollment of the first patients in the clinical trial for PF614-MPARTM is a critical milestone for this potentially transformative pain treatment option," said Ensysce's Chief Medical Officer Dr. William Schmidt. "The clinical data coming from this trial will guide our MPARTM drug product development. We intend to use the data to provide the building blocks to design a second trial at the end of 2022 to fully demonstrate the lifesaving overdose protection of our MPARTM technology."