On November 2, 2018, the SOMCT02 clinical trial successfully recruited its 15th patient, marking 50% fulfillment of its targeted number of patients. Recruitment rate is quite quick with all patients expected to be enrolled by the end of this year. 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 is 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 Vall d’Hebron, Hospital Universitari de Bellvitge, and Hospital Clínic de Barcelona, under the leadership of neurologist investigators Dr. Jaume Kulisevsky, Dr. Josep Gàmez, Dr. Matilde Calopa Garriga and Dr. Esteban Muñoz, respectively.