SOM Biotech announces Phase 2b study results

SOM Biotech presents the Phase 2b study results with SOM3355 demonstrating a unique profile with robust improvements of chorea in Huntington’s Disease Patients and a safe profile with no somnolence, no akathisia and no impact on depression, suicidality or cognition.

• SOM3355 is a drug with a novel mechanism of action combining mild beta 1-adrenergic antagonism with vesicular monoamine transporter subtype 1 and 2 (VMAT1 and VMAT2 respectively) inhibition suited for the treatment of movement and psychiatric disorders
• The study showed clinically-significant improvements in chorea measured by the Total Maximal Chorea (TMC) scale in a predefined population including all subjects not taking neuroleptics as concomitant medications and with a stable baseline TMC score (defined as at least 12 and corresponding to the upper limit of the mild range), in the SOM3355 600 mg/day dose arm.
• The Clinical Global Impression of Change and Patient Global Impression of Change (CGI-C and PGI-C) showed a remarkably higher percentage of improved (“much improved” and “improved”) subjects with a stronger effect in the 600 mg/day group, thus supporting the clinical significance of the chorea improvement.
• SOM3355 did not worsen patients’ depression, suicidal ideation and cognitive function. No side effects of somnolence, fatigue and akathisia were associated with the treatment with up to 600mg/day of SOM3355. Consistent treatment benefit of SOM3355 is shown on chorea when given at the dose of 600mg daily in patients without concomitant neuroleptics which are known to have a confounding role due to their effects on the dopamine pathway. Moreover, the safety profile of SOM3355 is confirmed with the absence of depression worsening, even improvement and no increased suicidality, no somnolence, no cognitive disfunction and no akathisia induced by the drug up to 600mg/day. The study results support continued development of SOM3355 for Chorea in subjects with Huntington’s disease.

“The data from this study reinforce the efficacy and safety of SOM3355 observed in the previous phase 2a study, showing clinically significant improvements in Huntington chorea associated with a safety profile characterized by no worsening of depression and suicidal thoughts, no somnolence, no akathisia and no effect on cognition” said Rossella Medori, M.D., Chief Medical Officer, SOM Biotech. “These are important findings that mark the unique profile of SOM3355 among the current treatments options, given that more than a third of patients living with Huntington’s disease chorea suffer from depression and up to one fifth have suicidal ideation that together with somnolence and cognitive impairment associated with present treatments may significantly disrupt daily life.”

Read the full press release here.