Suven Life Sciences, a clinical stage biopharmaceutical company discovering and developing novel medicines to treat Central Nervous System (CNS) disorders, today announced positive topline results from its Phase-2a proof-of-concept signal detection open label fixed-dose study assessing the safety and efficacy of Ropanicant (SUVN-911) for the treatment of moderate to severe Major Depressive Disorder (MDD). The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD. There are no significant differences in the safety profile across different doses and regimens. The secondary objective (efficacy objective) was to assess the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 2. 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.
"These findings from the Phase-2 study mark a significant milestone in our efforts to address the unmet medical need in treating moderate to severe Major Depressive Disorder patients. We are deeply grateful to the patients and investigators for their contributions." said Mr. Venkat Jasti, Chairman & MD of Suven Life Sciences.
"We are greatly encouraged by the strong signal and rapid onset of action observed in this study. The study met the criteria for a positive outcome, supporting our decision to advance Ropanicant to the double-blind, placebo-controlled Phase-2b study which we expect to initiate in early 2025." said Ramakrishna Nirogi, Vice President, Drug Discovery & Development, Suven Life Sciences.
Topline data from this clinical study will be presented at the Neuroscience-2024 (Society for Neuroscience annual meeting) to be held at Chicago, USA during 5-9th October, 2024.
Shares of Suven Life Sciences Limited was last trading in BSE at Rs. 156.50 as compared to the previous close of Rs. 164.75. The total number of shares traded during the day was 95928 in over 2276 trades.
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