SOM Biotech, a clinical-stage drug discovery and development company based on a unique proprietary artificial intelligence (AI) platform, is pleased to announce the database lock of the Phase IIb study SOMCT03 with SOM3355 for the treatment of chorea in Huntington’s disease (HD).
SOM3355 was selected by SOM Biotech through its AI computer system SOMAIPRO®, as a potent inhibitor of vesicular monoamine transporter type 2 (VMAT2) with distinct chemical structure and distinct interaction with the VMAT2 receptor than existing monoamine depleting agents.
The Phase IIb study is a dose finding, 12-week, double-blind, randomised study assessing in parallel the efficacy and safety of two dose regimens of SOM3355 (200mg or 300mg given twice a day) compared to placebo. A total of 140 patients diagnosed with manifest HD, mildly to moderately impaired, suffering from choreic movements have been randomised.
The database was locked on 17 July 2024 and the initial data on the primary endpoint are expected in August.
“We are happy for the achievement of this important milestone and we look forward to the top-line results next month. We believe that SOM3355 has the potentiality to be a valid option for the treatment Huntington chorea patients,” says Raul Insa, CEO of SOM Biotech.
Silvia Panigone, executive chair, adds: “The company is planning to open a Series B round by the end of 2024 to potentially run a pivotal study with SOM3355, alone or in partnership, and advance with the other products in SOM’s pipeline. Our goal is to reach an exit inflection point or a listing on the NASDAQ in about two years.”