On March 8, 2019, the SOMCT02 clinical trial successfully closed recruitment, marking 100% fulfillment of its targeted number of patients. SOM Biotech is very proud of all the efforts being done by the participating sites, and we are expecting to achieve good results from this clinical trial which will cover a great medical need in patients with Huntington’s disease.
SOMCT02 is a Phase 2a proof-of-concept and is designed as a randomized, double-blind, placebo-controlled, 2-arm, 27-week study to evaluate the safety and efficacy of SOM3355 in Huntington’s disease (HD) patients with chorea movements. Recruitment started in August 2018 and a total of 30 patients were aimed to be enrolled to the study. The primary efficacy endpoint is the improvement in Total Maximal Chorea score, and the secondary endpoints involve the different domains of the disease such as impression of change, functional capacity, gait and motor scores, as well as safety.
The clinical trial is conducted in four major hospitals in Barcelona, Spain: Hospital de la Santa Creu i Sant Pau, Hospital Universitari de Bellvitge, Hospital Clínic de Barcelona and Hospital Universitari Vall d’Hebron, under the leadership of neurologist investigators Dr. Jaume Kulisevsky, Dr. Matilde Calopa Garriga, Dr. Esteban Muñoz and Dr. Josep Gàmez, respectively.