SOM Biotech announces the completion of recruitment in the Phase IIb study of the treatment of chorea in Huntington’s disease patients with SOM3355

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 commercialized 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 multicentric 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 FDA and EMA for further guidance on the path to marketing approval.

About SOM Biotech: SOM Biotech (www.sombiotech.com), headquartered in Barcelona, Spain, is a biopharmaceutical company founded in 2009. It is based on a unique proprietary AI platform (SOMAIPRO) to identify new mechanisms of action of existing small molecule drugs for the treatment of diseases of high unmet medical need with a focus on orphan disorders of the CNS. SOMAIPRO is the only AI drug discovery platform whose products have achieved positive Phase II outcomes in patients, demonstrating the high clinical predictive value of the platform. SOM leverages on an extensive pipeline of products developed for the treatment of orphan indications including Transthyretin Amyloidosis, chorea in Huntington's disease, Phenylketonuria, Duchenne Muscular Dystrophy and Tardive Dyskinesia. The Transthyretin Amyloidosis product was out-licensed upon positive Phase IIa data.

SOM is led by an experienced team with a successful track record in both drug development and AI platforms development.

For more information about SOM Biotech, please contact: info@sombiotech.com"