Ensysce Biosciences has announced positive interim data from its Phase 1b clinical trial evaluating PF614-MPAR for overdose protection. The study, known as PF614-MPAR-102, is designed to assess the pharmacokinetics of oxycodone and PF614 when co-administered with nafamostat in healthy subjects.
The trial investigates the full dosage range of PF614-MPAR, potential food effects, and includes a multiple ascending dose study. PF614-MPAR received Breakthrough Therapy designation from the FDA in 2024 and is supported by a $14 million multi-year award from the National Institute on Drug Abuse (NIDA).
Key Findings from PF614-MPAR-102
Data from the PF614-MPAR-102 study indicate that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. Subjects in the trial received three doses of the overdose-protected PF614-MPAR versus PF614 alone.
The results showed that subjects receiving PF614-MPAR had a significantly lower (p=0.0019) total maximum blood concentration (Cmax) of oxycodone compared to those receiving PF614 alone, suggesting overdose protection. No significant difference in Cmax values (p=0.523) was observed between subjects receiving a single 100 mg dose of PF614 or PF614-MPAR, as designed.
Safety and Next Steps
Safety data from the trial revealed no unexpected adverse events associated with either PF614 or PF614-MPAR. The trial is ongoing and will proceed with enrolling the final cohorts of Part 1, followed by Part 2 to examine potential food effects, and Part 3 to evaluate repeat dosing of PF614 vs. PF614-MPAR over 4.5 days.
Management Commentary
"Clinical data from our initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA's Breakthrough Therapy designation, a first for an opioid drug product," said Dr. Bill Schmidt, Chief Medical Officer of Ensysce. "This second study builds on the initial data and further demonstrates that MPAR is a vital tool to limit unwanted overdoses from prescription medications. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is being realized."
Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "We are delighted with the positive early interim data which confirms that MPAR provides overdose protection in the planned dosage range for our PF614-MPAR drug product... We look forward to completing this highly important three-part trial and generating additional evidence to conduct productive discussions with the FDA on the path to registration for the first overdose-protected opioid."
