In 2022, Ensysce Biosciences made significant progress in its mission to improve prescription drug safety, focusing on reducing abuse and overdose through its innovative technology platforms, TAAP™ and MPAR™. The company achieved key milestones in its clinical development programs, particularly with its lead product, PF614, a "Trypsin-Activated Abuse Protection" (TAAP™) oxycodone prodrug. PF614 is designed to offer strong efficacy while being highly resistant to tampering and abuse, marking a new generation of opioid pain medication.
Ensysce initiated three clinical studies for PF614, including a bioequivalence study that compared PF614 to OxyContin, showing positive results that could support PF614's substitution for OxyContin in the market. Additionally, Human Abuse Potential (HAP) studies were conducted to evaluate the abuse-deterrent properties of PF614, with promising results indicating reduced drug liking among users.
The company's second program, PF614-MPAR™, aims to add overdose protection to the abuse protection offered by TAAP™. This program has received significant support from the National Institute on Drug Abuse (NIDA) and the federal government HEAL initiative, with a total funding of $10.8 million. Ensysce also partnered with Quotient Sciences to advance the development and clinical testing of PF614-MPAR™, aiming to optimize the product for pain relief while preventing overdose.
Financially, Ensysce strengthened its position with an $8.0 million convertible note financing and a $4.1 million public offering. The company also expanded its Board of Directors with the appointment of Lee Rauch, bringing extensive experience in the biotech industry.
Looking ahead, Ensysce is focused on continuing its clinical development timeline, with additional data from its oral HAP study expected in the first quarter of 2023 and further development of PF614-MPAR™ planned for the second half of the year. The company aims to engage in regulatory discussions with the FDA and initiate additional clinical studies for PF614 by the end of 2023.
Ensysce Biosciences remains committed to addressing the prescription drug abuse epidemic, both in the U.S. and globally, through its innovative technology platforms and dedication to creating safer pain management solutions.