SOM Biotech has received on 18th June 2018 the approval of the Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct its Phase IIa, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of SOM3355 in patients with choreic movements associated with Huntington’s disease.
The study will be 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. The company expects to start enrollment this quarter.
The investigational product, SOM3355, is a repositioned drug previously approved for another indication. It is an oral and brain penetrant drug that selectively inhibits Vesicular Monoamine Transporter-2 (VMAT2). The molecule causes a decrease in the levels of Dopamine, which plays an essential role in the control of coordinated movements, thus reducing choreic movements associated with Huntington’s disease.