Spanish clinical-stage biopharmaceutical company SOM Biotech has begun a Phase lla clinical trial to examine the safety and efficacy of SOM3355 for the treatment of the chorea movements associated with Huntington's disease (HD), an orphan progressive neurodegenerative condition.
The proof-of-concept, randomised, double-blind, placebo-controlled, two-arm, 27-week trial aims to enrol 30 patients.
The trial’s primary efficacy endpoint is the improvement of Total Maximal Chorea score, while the secondary endpoints include impression of change, functional capacity, gait and motor scores, and safety.
Spain’s Hospital de la Santa Creu i Sant Pau representative Dr Jaume Kulisevsky is the principal investigator of the trial, which will be conducted at various sites in Spain, including Hospital Universitari de Bellvitge, Hospital Clínic de Barcelona and Hospital Universitari Vall d'Hebron.
SOM Biotech CEO Dr Jaime Kulisevsky said: “Currently, the treatment of movement disorders in Huntington's disease is limited by the side effects of the drugs used.
“SOM3355 offers a promising alternative to improve the tools available to treat the disease. The clinical trial that we begin has a double-blind and randomised design that will allow to verify objectively the ability of the drug to improve abnormal movements.
“The participation of four centres in our environment will facilitate the recruitment of the sufficient number of patients and guarantee the objectivity of the results.”
SOM3355 is an investigational repositioned drug previously approved for another indication.
The oral and brain penetrant drug is a cardioselective β1‐adrenoceptor antagonist discovered by SOM Biotech as a potential selective inhibitor of Vesicular Monoamine Transporter-2 (VMAT2).