Ensysce Biosciences, Inc. (ENSC)

Ensysce Biosciences is a clinical stage pharmaceutical company developing treatments for severe pain relief that aim to reduce the potential for opioid misuse, abuse and overdose. Its product candidates are designed to improve the safety of prescription drugs, with a primary focus on opioid pain products and opioid use disorder products. The company was incorporated in Delaware in April 2003 as PharmacoFore, Inc., was renamed Signature Therapeutics in 2012, and became Ensysce through a 2015 merger. In June 2021 it completed a merger with LACQ, which took the Ensysce Biosciences name, and the former Ensysce became its subsidiary, EBI OpCo, Inc.

The pipeline rests on two prodrug platforms and includes three clinical-stage candidates. The Trypsin Activated Abuse Protection (TAAP) platform is designed to release active drug only when the drug is ingested and exposed to the digestive enzyme trypsin, so that crushing, chewing, extraction, injection or snorting should not release the opioid. The Multi-Pill Abuse Resistant (MPAR®) platform combines a TAAP prodrug with nafamostat, a trypsin inhibitor, so that taking more than the prescribed number of doses inhibits activation and limits overdose. The lead candidate, PF614, is a TAAP oxycodone prodrug. It has completed a Phase 1 single-ascending-dose study, a Phase 1b multiple-ascending-dose and bioequivalence study (100 mg PF614 was bioequivalent to 40 mg OxyContin), nasal and oral human abuse potential studies, and an efficacy study completed in December 2023 whose data will inform Phase 3 design. The company says the bioequivalence data may allow the 505(b)(2) regulatory path. PF614-MPAR, the combination with nafamostat, showed overdose protection in Phase 1 and received FDA Breakthrough Therapy designation in January 2024. Nafamostat is also being developed in oral form for coronaviral infections and pulmonary diseases such as cystic fibrosis, and a Phase 1 trial was completed in 2021. That program is not the current primary focus. The company also has other TAAP and MPAR opioid and amphetamine candidates that could be developed.

The company targets patients with acute and chronic pain in the United States, citing 153 million opioid prescriptions in 2021 and a $4.2 billion market, along with the burden of prescription opioid abuse, overdose deaths and opioid use disorder. It also points to the misuse of stimulants such as amphetamines as a further area where abuse-resistant products could apply. It describes PF614 as a potentially safer alternative to the abuse-deterrent formulation products now on the market, such as OxyContin OP and Xtampza ER.

Clinical trials have been run through contract research organizations, including PRA Health Sciences (now ICON) for the PF614 Phase 1 and 1b studies. The company is testing MPAR with Quotient Sciences, using its Translational Pharmaceutics® platform, to find a formulation that converts to oxycodone within the prescribed range but not at higher doses. Its principal executive office is at 7946 Ivanhoe Avenue, Suite 201, La Jolla, California.