Ensysce Biosciences announces interim data for PF614-MPAR

Ensysce Biosciences (ENSC) announced interim data from its second clinical trial to evaluate PF614-MPAR for overdose protection. Clinical study PF614-MPAR-102, ‘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 of Immediate Release Solution and Extended Release Capsule Formulations in Healthy Subjects,’ was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination. In 2024, PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration, and had its development bolstered by a $14 million multi-year award from the National Institute on Drug Abuse to continue studying the PF614-MPAR overdose protection observed in an initial clinical study, PF614-MPAR-101. The PF614-MPAR-102 study showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. Subjects were studied as their own control and received three doses of the overdose-protected PF614-MPAR versus PF614. The subjects receiving the MPAR product had a significantly lower total maximum blood concentration of oxycodone compared to PF614 alone, an indication of overdose protection. As designed, subjects who received a single 100 mg dose of PF614 or PF614 MPAR showed no difference in Cmax values. Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR. The trial will now continue to enroll the final cohorts of Part 1 of the study and then move to Part 2, which is designed to examine potential food effects. Part 3 will then evaluate repeat dosing of PF614 vs. PF614-MPAR over 4.5 days. The aggregation of interim data allows the Company to focus on perfecting a final drug product to move to commercialization.