Suven Life Sciences announced the randomization of first patient in the Phase-2 clinical trial of Ropanicant (SUVN-911) for the treatment of moderate to severe Major Depressive Disorder (MDD) study in USA. The trial is a multicenter, randomized, open-label, parallel-group study planned across 10 sites in the USA. The study will enroll approximately 36 patients who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for MDD without psychotic features and a diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).

Patients will be randomized in a 1:1:1 ratio (12 patients in each treatment group) to receive ro panicant either 45 mg once a day, 30 mg twice a day, or 45 mg twice a day. Following a screening period of up to 4 weeks, the patients will be treated for 2 weeks. The primary objective is to evaluate the safety and tolerability of ro panicant in patients with MDD.

The secondary objective (efficacy objective) is to assess the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 2. Topline data from the trial is expected to be available by Oct 2024.