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Ensysce Biosciences Achieves Successful Completion of Part A of Multiple-Ascending Dose (MAD)/Bioequivalents (BE) Trial for its Next Generation Opioid, PF614
SAN DIEGO, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, Jan. 04, 2022 (GLOBE NEWSWIRE) -- 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 e...