Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical firm dedicated to developing novel prescription drugs for the treatment of severe pain in the United States, with a specific focus on preventing opioid addiction, misuse, abuse, and overdose. The company leverages two primary technological frameworks: the Trypsin Activated Abuse Protection (TAAP) platform, which creates opioid prodrugs designed to resist abuse, and the Multi-Pill Abuse Resistance (MPAR) platform, engineered to offer protection against overdose through its advanced opioid prodrug technology. Ensysce's pipeline features several key candidates, including PF614, an oxycodone prodrug developed using the TAAP platform, currently undergoing Phase II clinical trials for both acute and chronic pain management. Another product, PF614-MPAR, is a combination of PF614 and nafamostat, in Phase I clinical development to provide overdose protection against excessive oral consumption. Furthermore, the company is exploring an oral and inhaled formulation of nafamostat for potential use against coronaviral infections and other pulmonary diseases, such as cystic fibrosis. The company's development efforts also include PF329, an extended-release hydromorphone prodrug similar to PF614. In the area of ADHD treatment, Ensysce is advancing PF8001 and PF8026, which are extended-release and immediate-release amphetamine prodrugs, respectively, aimed at deterring medication abuse. Additionally, PF26810, an extended-release methadone prodrug, is in development for opioid use disorder. Ensysce Biosciences, Inc. operates from its headquarters in La Jolla, California.
Ensysce Biosciences Phase 2 Protocol for CY200 - A Neuroplastigen for the Treatment of CRPS - Submitted to the UK MHRA
Ensysce Biosciences submitted the Phase 2a protocol (CYBIO_001) for CY200, a neuroplastigen, to the UK MHRA for treatment of Complex Regional Pain Syndrome Type 1.
The multicenter, randomized, double-blind, placebo-controlled proof-of-concept study will evaluate CY200's analgesic efficacy, safety, and tolerability in adults.
CY200 comes from the recently acquired Cy Biopharma Inc.; MHRA review is a pivotal step toward trial initiation. No financial figures were disclosed, and forward-looking statements flag possible Nasdaq delisting and financing risks.