SOM Biotech, a clinical-stage drug discovery and development company based on a unique proprietary artificial intelligence platform (SOMAIPRO®), is pleased to announce that the recruitment of the Phase IIb clinical study with SOM3355 as a treatment for Huntington’s chorea has been completed.
SOM3355, identified through SOMAIPRO®, is a potent inhibitor of vesicular monoamine transporter type 2 (VMAT2) with a different chemical structure than the other commercialised VMAT2 inhibitors.
Following a Phase IIa study in Huntington patients which confirmed the good safe profile and clinical benefit on choreic movements, SOM Biotech conducted a 12-weeks double-blind, placebo-controlled dose-finding Phase IIb study, assessing the efficacy and safety of two dose regimens. A total of 140 patients were included. The primary efficacy outcome is the change of the Total Maximal Chorea score (TMC) from baseline to the end of treatment. This international multi-centre study was endorsed by the European Huntington’s Disease Network and conducted with the support of the Enroll-HD clinical research platform.
“We thank all the clinical sites and the people involved in the study that worked hard to meet this important milestone,” said Dr Catherine Scart, SOM’s chief medical officer. “There have been no safety concerns to date and final report on the Phase IIb results is expected by the end of the year. Given the significant unmet need, SOM3355 can be a first option to treat chorea in Huntington patients thanks to its extremely safe profile compared to the current standard-of-care.” SOM Biotech intends to consult with the US Food and Drug Administration (FDA) and European Medical Agency (EMA) for further guidance on the path to marketing approval.