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News & Announcements , Customer Milestone , Translational Pharmaceutics®

Ensysce Biosciences' PF614-MPAR Enters Final Stage of Phase 1 Study

Ensysce Biosciences and Quotient Sciences logos

Ensysce Biosciences' PF614-MPAR, the overdose protectionversion of its lead product, PF614, could become the industry's first overdose protection pain product. Quotient Sciences are partnering with Ensysce on the Phase I study for the product, led at our Miami, FL, facility by Dr. Maria Bermudez, MD, Senior Medical Director. Read Ensysce's recent announcement regarding the initiation of the final stage of the Phase 1 study.

SAN DIEGO, CA / ACCESSWIRE / January 25, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), (OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced the initiation of the final stage of the Phase 1 study of PF614-MPAR. PF614-MPAR is the overdose protectionversion of its lead product, PF614, and this keystudy is being conducted in healthy subjects by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.

PF614, a TAAPTM prodrug of oxycodone, has a number of safety features designed to reduce abuse, including its extended-release profile that has been shown to reduce ‘drug liking' in recreational drug users. Additionally, its requirement for exposure to the enzyme trypsin to release oxycodone reduces the ability of recreational users to chew, crush and snort, or manipulate and inject to change the opioid release profile. The combination product PF614-MPAR has another layer of safety, with an added trypsin inhibitor to prevent overdose.

The recently completed initial stage of the trial sought to optimize PF614-MPAR (the PF614/nafamostat combination) for both release rate and ratio of the combination. Data from the trialdemonstrated that PF614-MPAR could deliver oxycodone similarly toPF614, which was the goal of the study. In line with expectations, the results of the study demonstrated that an overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of PF614. In the final stage of the study, the selected PF614-MPAR formulation will be evaluated by measuring oxycodone release from increasing dose units delivered to a group of healthy subjects.

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