Ensysce Biosciences, listed on NASDAQ under ENSC, submitted a Phase 2a clinical study protocol to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its investigational drug CY200, targeting Complex Regional Pain Syndrome (CRPS) Type 1.
The proposed CYBIO_001 trial is designed as a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CY200 in adult participants with CRPS Type 1. The drug candidate was acquired from Cy Biopharma Inc.
CRPS Type 1 is a condition characterized by continuous pain, tenderness, stiffness, and swelling in a limb, severely impacting work and daily activities. It most commonly affects women and frequently develops after injury or surgery, with fractures being the most common trigger. Current treatments are either used off-label or provide supportive care focused on symptom management.
CY200 is believed to exert neuroplastogenic effects that may help reset abnormalities in the brain and reduce abnormal brain connections, according to the company.
Dr. Richard Langford, Chief Medical Officer of Cy Biopharma, said: "For people living with Complex Regional Pain Syndrome, the need for a meaningful new treatment could not be more urgent. The MHRA review marks a pivotal step toward initiating our Phase 2a study."
Ensysce shares closed at $0.4145 on the day of the announcement, down 3.38%, and traded at $0.40 in pre-market activity, representing a 3.50% decline.
