Ensysce Biosciences Receives Notice of Award for Year 3 of Multi-Year NIDA Grant for the Clinical Development of its Next-Generation Opioid Products With Overdose Protection

Ensysce Biosciences, Inc. recently announced receipt of the third year award of a multi-year grant from the National Institute on Drug Abuse (NIDA). This award will provide $2.8 million to initiate a Phase 1 study of the first MPAR overdose protection product in the US, PF614-MPAR. This brings the total support of NIDA to $8 million. An additional $2.8 million award for year four is pending.

“We are honored to receive the UH3 award titled PF614 MPAR Abuse Deterrent opioid prodrug with overdose protection: Pre-Clinical Development and Phase 1 Clinical Trial from the National Institute on Drug Abuse, which provides us with additional resources to continue our work to bring PF614-MPAR into clinical development,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences. “Importantly, our next-generation opioid platform is highly differentiated from currently marketed opioid products and designed to significantly reduce abuse potential and overdose protection. We remain focused on our commitment to stem the prescription drug abuse epidemic and look forward to bringing our unique pipeline of products to the industry, which will ultimately provide safer options for both prescribers and patients.”

PF614-MPAR is designed as an extended-release oxycodone prodrug with both trypsin-activated abuse protection (TAAP) and overdose protection through multi-pill abuse resistance (MPAR) technology. TAAP chemical modification inactivates the active ingredient in PF614 to provide abuse deterrence, and the combination with the trypsin inhibitor, nafamostat, in MPAR provides the additional layer of overdose protection. The MPAR overdose protection has been demonstrated in animals and the Phase 1 study with PF614 is being conducted to further validate the MPAR overdose protection technology. The Phase 1 study trial, A Single Dose Study to Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614 Solution is Co-Administered with Nafamostat, as an Immediate Release Solution and/or Extended Release (ER) Capsule Formulations in Healthy Subjects is being conducted by Dr. Maricer Escalon, MD, MS, MBA, at Quotient Sciences.

“This award further confirms Ensysce’s important TAAP and MPAR technology, which has been recognized by NIH, NIDA and the Federal Government,” said Dr. William Schmidt, Chief Medical Officer of Ensysce. “We remain committed to addressing the significant unmet needs in the marketplace, and look forward to advancing our pipeline of opioid TAAP and MPAR™ products to combat the opioid crisis.”

Ensysce Biosciences, San Diego, CA, is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) platforms, the company is in the process of developing a new class of powerful, tamper-proof opioids that prevent both drug abuse and overdoses. Ensysce’s products are anticipated to provide safer options to treat severe pain and assist in preventing deaths caused by opioid abuse, reducing the human and economic cost. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, visit www.ensysce.com.