Ensysce Biosciences Inc. (NASDAQ: ENSC) has announced the completion of part A of the previously announced PF614-102 clinical trial, “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,” carried by Matthew Johnston.
Part A study evaluated different doses
Part A of the study looked at three different doses of PF614 given orally twice per day for 5 days to healthy volunteers. Additional individuals in the trial were given OxyContin at three different dose levels. Following the completion of each cohort, the trial’s independent Safety Review Committee gave the experiment the green light to move on to the next dose level. All 3 dosage cycles have now been finished successfully. The company is now moving on to the BE phase of the study after successfully completing the MAD phase. MAD data will be fully examined in Q1 2022, with BE study results following in Q2 2022.
CEO Lynn Kirkpatrick stated, “The final enrollment of the last cohort of subjects and positive safety review at the highest dosage level represents 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, negatively impacts 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.”
MAD phase study exceeded expectations
“The MAD phase of the trial exceeded our expectations and further advances the possibility of bringing our ‘next generation’ opioids to the market. In addition, 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,” added chief medical officer William Schmidt.
