Suven Life Sciences has recently informed exchanges about the positive topline results from its Phase-2a proof-of-concept signal detection open label fixed-dose study that assessed the safety and efficacy of Ropanicant for the treatment of moderate to severe Major Depressive Disorder (MDD).
The primary goal was to assess the safety and tolerability of Ropanicant in patients with MDD. As per the company, there are no notable changes in the safety profile between doses and regimens. Evaluating the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 2 was the secondary goal (efficacy objective).
In the exchange filing, the company also shared, “The changes from the baseline in MADRS score at Week 2 are highly statistically significant (p < 0.0001) for all treatment groups and are consistent with the approved agents used to treat MDD patients. Treatment with Ropanicant resulted in mean improvement from the baseline in MADRS total score of 5.9 to 13.4 points at Day 7, and 10.4 to 12.7 points at Day 14 across different doses. The baseline MADRS score of patients entering the study was 32.1, representing moderate to severe depression.”
