Ensysce Biosciences, a clinical-stage biotech company, is making strides in developing safer prescription drugs to combat opioid abuse and overdose. The company's two lead programs, utilizing the Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR™) technology platforms, aim to provide effective pain relief while reducing the risks associated with traditional opioid medications.
Clinical Progress with PF614
PF614, Ensysce's lead product, is a TAAP™ oxycodone prodrug designed to be highly resistant to tampering and abuse. In 2022, Ensysce initiated three clinical studies to advance PF614. A bioequivalence study (PF614-102) compared PF614 to OxyContin, with data suggesting that PF614 could potentially substitute OxyContin in the market. The company believes the data supports the 505(b)(2) regulatory pathway for clinical development of PF614.
Two Human Abuse Potential (HAP) studies, PF614-103 and PF614-104, were conducted to assess the "drug liking" of PF614 versus oxycodone in recreational drug users. The first inhalation study (PF614-103) showed positive topline results, with PF614 demonstrating significantly reduced "drug liking" compared to inhaled crushed immediate-release oxycodone. Enrollment for the second HAP study (PF614-104), comparing oral administration of PF614 versus oxycodone or placebo, was completed in December 2022, with data expected in early 2023.
Advancing Overdose Protection with PF614-MPAR™
Ensysce is also developing PF614-MPAR™, a combination product that adds overdose protection to the abuse-deterrent properties of TAAP™. The MPAR™ technology is designed to halt the release of the opioid in an overdose situation. This program has received funding from the National Institute on Drug Abuse (NIDA) and the HEAL (Helping End Addiction Long-term) initiative.
In November 2022, Ensysce completed Part A of the clinical portion of the overdose protection trial PF614-MPAR-101. The data indicated successful demonstration of opioid overdose protection with PF614-MPAR™. The study is being expanded into a Part B in 2023 to further confirm the overdose protection capabilities of PF614-MPAR™.
Financial and Operational Updates
Ensysce Biosciences has taken several steps to strengthen its financial position, including an $8.0 million convertible note financing and a $4.1 million public offering. The company is focused on executing its clinical development timeline, with plans for regulatory discussions with the FDA and additional clinical studies for PF614 by the end of the year.
The Opioid Crisis and Ensysce's Mission
The opioid crisis continues to be a significant public health issue, with over 100,000 lives lost each year due to overdose. Ensysce Biosciences is committed to providing powerful pain relief while addressing the prescription drug abuse epidemic. The company's technology platforms have the potential to be applied to various classes of prescription drugs, offering safer medication options globally.
