Benzinga | Jan 4, 2022 08:05AM EST

Ensysce Biosciences Reports Achieved Successful Completion Of Part A Of Multiple-Ascending Dose/Bioequivalents Trial For PF614

Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC, OTC:ENSCW), a clinical-stage biotech company with novel technologies that may provide new hope for those in severe pain, today announced that it has successfully completed Part A of the previously announced clinical study PF614-102, "A Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics (PK) and Safety of Multiple-Ascending Oral Doses (MAD) of PF614 and the Food Effect and Bioavailability/Bioequivalence (BE) of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects," conducted by Matthew Johnston, MD, PRA Health Sciences, Salt Lake City, Utah.

The Part A of the trial evaluated three dose levels of PF614 delivered orally, twice daily for five days to healthy subjects. Additional study participants received OxyContin at three comparable dose levels. Following completion of each cohort, a positive review from the trial's independent Safety Review Committee allowed the trial to proceed to the next dose level. All three dose levels have now been successfully completed.

With this successful completion of the MAD portion, the Company is progressing to the BE stage of the study. Fully analyzed MAD data is expected in the first quarter of 2022, with the BE study results to follow in the second quarter. Safety and PK data is scheduled to be presented at the 2022 Pain Therapeutic Conference to be held in London, UK, in May 2022.

Dr. Lynn Kirkpatrick, CEO, commented, "The final enrollment of the last cohort of subjects and positive safety review at the highest dosage level, represent a significant milestone for Ensysce. We believe we are well on our way to finding a safe and effective treatment for severe pain, which, if successful, delivers a major impact on the current abuse of prescription pain medications. We are eager to begin the second phase of the two-part study and anticipate having results by the end of the second quarter of 2022."

Dr. William Schmidt, Chief Medical Officer added, "The MAD phase of the trial exceeded our expectations, and further advances the possibility of bringing our 'next generation' opioids to the market. PK data confirmed similar dose-proportionate increases in plasma oxycodone following PF614 and OxyContin and there were no unexpected adverse events in either the PF614 or OxyContin dose groups. This creates a strong foundation for our mission of developing unique platforms to stop abuse and overdose of prescription drugs."

PF614 is designed as a delayed onset oxycodone prodrug with trypsin-activated abuse protection (TAAP). TAAP chemical modification inactivates the active ingredient in Ensysce's opioids products including PF614. This provides abuse deterrence, resistance to manipulation and other forms of recreational drug abuse, while providing a high degree of pain relief for those in severe pain. This study builds on the safety and pharmacokinetic results already seen in the prior Phase 1 study and improves the understanding of how PF614 compares to currently available commercial products.