Suven Life Sciences Reports Positive Topline Results from Phase-2b Trial of Ropanicant for Major Depressive Disorder

Suven Life Sciences Reports Positive Topline Results from Phase-2b Trial of Ropanicant for Major Depressive Disorder​

Suven Life Sciences Limited, a biopharmaceutical company specializing in treatments for Central Nervous System (CNS) disorders, has announced positive top-line results from its Phase-2b clinical proof-of-concept trial of Ropanicant for the treatment of Major Depressive Disorder (MDD). Ropanicant is an investigational nicotinic $\alpha 4 \beta 2$ receptor antagonist in development.

The Phase-2b trial demonstrated that twice daily oral administration of Ropanicant 45 mg resulted in a clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6, which served as the primary endpoint.

Key efficacy data from the study are presented below:


The results for the MADRS are notable, as existing clinical evidence identifies a difference of approximately two points in the MADRS total score versus placebo as clinically meaningful. Evidence of treatment benefit was also observed across several secondary endpoints.

Secondary endpoint outcomes included:

• Clinical Global Impression-Severity of Illness (CGI-S; p = 0.094)
• Sheehan Disability Scale (SDS; p = 0.039)
• Exploratory Quality of Life in Depression Scale (QLDS; p = 0.068)

Improvements observed in anhedonia correlated with improvements in measures of functioning and quality of life.

Safety and Trial Characteristics​

The study, which enrolled 214 patients across 35 sites exclusively within the United States of America, spanned a duration of six weeks. The trial was a randomized, double-blind, placebo-controlled assessment of Ropanicant 45 mg or 30 mg administered twice daily against placebo in improving depression symptoms measured by the MADRS.

Ropanicant was generally well tolerated by patients with MDD. Most adverse events (TEAEs) reported during the study were mild to moderate, and no unexpected safety signals were identified. The company noted that there was no evidence of dissociation and no withdrawal symptoms after discontinuing Ropanicant treatment.

Baseline demographic and clinical characteristics were comparable across both the placebo and Ropanicant treatment groups, indicating a well-balanced study population at baseline. Baseline mean scores across various indicators included:

• MADRS (Mean score approximately 31)
• CGI-S (Approximately 4.3 to 4.5)
• Functional Impairment (Sheehan Disability Scale Total score approximately 19.6 to 21.2)
• Quality of Life in Depression Scale (Total score approximately 21.7 to 22.4)
• Pleasure (Snaith-Hamilton Pleasure Scale Total score approximately 39.4 to 39.6)
• Depressive Symptoms (Patient Health Questionnaire-9 Total score approximately 16.7)

Future Strategy and Development of Ropanicant​

The company announced plans for a global Phase-3 registrational study in MDD following these results. Detailed findings from the clinical study are slated to be presented at future medical conferences and peer-reviewed journal publications. Furthermore, a priority patent application has been filed, with an International Application planned within days.

Ropanicant (SUVN-911) is described as a novel, selective nicotinic $\alpha 4 \beta 2$ receptor antagonist that holds promise for MDD by potentially addressing limitations of current treatments such as rapid onset of action and reduced sexual dysfunction. Phase-2a trials had previously demonstrated a favorable safety profile and significant improvements in depressive symptoms measured by MADRS score.

Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, stated that the Phase-2b outcome demonstrates clinically meaningful treatment benefits, positioning Ropanicant as a promising option given the significant unmet medical need in MDD. Mr. Ramakrishna Nirogi, President and CSO of Suven Life Sciences, added that the data supports Ropanicant’s potential, and the company looks forward to engaging with regulatory authorities worldwide regarding Phase-3 clinical development plans.

Suven Life Sciences Limited focuses on developing innovative medicines for CNS disorders, including Alzheimer's disease (AD), Sleep disorders, MDD, Parkinson's disease (PD), Schizophrenia, Pain disorders, and Gastrointestinal disorders.

SUVEN Stock Price Movement​

Shares of Suven Life Sciences Limited are edging higher to ₹272.05 as of 12:38 PM today, gaining 0.82% in live trading. The stock has traded within an intraday range defined by a low of ₹265.6 and a high of ₹276.9 during the session.