Breakthrough Opioid Study Advances: Ensysce Biosciences Gets IRB Nod for Final Phase of PF614-MPAR-102
Summary
Ensysce Biosciences has secured Investigational Review Board (IRB) approval to initiate Part 3, the final stage, of its PF614-MPAR-102 clinical study. This is a significant step for the company's lead opioid candidate, PF614-MPAR, which incorporates Multi-Pill Abuse Resistance (MPAR®) technology and has received Breakthrough Therapy designation from the U.S. FDA. The approval allows the company to proceed with further characterizing the drug's overdose-protection capabilities, advancing a novel opioid designed to minimize abuse and overdose risk. This positive operational milestone provides a key clinical development for the micro-cap pharmaceutical company, following recent financing activities and a significant S-3 filing for potential share dilution.
At the time of this announcement, ENSC was trading at $0.54 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5M. The 52-week trading range was $0.31 to $4.85. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Access Newswire.