Announcement • Jun 18
Suven Life Sciences Announces Positive Topline Results from Phase-2B Clinical Proof-Of-Concept Trial of Ropanicant for the Treatment of Major Depressive Disorder
Suven Life Sciences Limited announced topline results from the Phase-2b clinical proof-of-concept trial of Ropanicant for Major Depressive Disorder (MDD). Ropanicant is an investigational nicotinic a4ß2 receptor antagonist in development as a potential treatment for patients with MDD. The Phase-2b clinical trial demonstrated that twice daily oral administration of Ropanicant 45 mg resulted in a clinically meaningful change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS) total score at Week 6, the primary endpoint. The maximum likelihood (ML) - estimated mean difference from baseline versus placebo is -3.572 in the Full Analysis Set (p = 0.038), -3.570 in the modified Full Analysis Set (p = 0.038) and -4.067 in the Per-Protocol Set (p = 0.023). Existing clinical evidence identifies a difference of approximately 2 points in MADRS total score versus placebo as clinically meaningful. Evidence of treatment benefit was observed across secondary endpoints, including Clinical Global Impression–Severity of Illness (CGI-S) and the Sheehan Disability Scale (SDS), as well as the exploratory Quality of Life in Depression Scale. Improvements in anhedonia correlated with improvements in measures of functioning and quality of life. No withdrawal symptoms after discontinuation of Ropanicant treatment. No evidence of Dissociation. Global Phase-3 registrational study in MDD is being planned. Evidence of treatment benefit of twice daily Ropanicant 45 mg was observed across secondary endpoints, including Clinical Global Impression–Severity of Illness (CGI-S; p = 0.094) and the Sheehan Disability Scale (SDS; p = 0.039), as well as the exploratory Quality of Life in Depression Scale (QLDS; p = 0.068). The baseline demographic and clinical characteristics were comparable across the placebo and Ropanicant treatment groups. The mean scores for depression severity (MADRS ~31), global illness severity (CGI-S ~4.3–4.5), functional impairment (Sheehan Disability Scale Total score ~19.6–21.2), quality of life (Quality of Life in Depression Scale Total score ~21.7–22.4), pleasure (Snaith-Hamilton Pleasure Scale Total score ~39.4–39.6), and depressive symptoms (Patient Health Questionnaire-9 Total score ~16.7) were similar across all groups, indicating a well-balanced study population at baseline. Ropanicant was generally well tolerated in patients with MDD. The majority of treatment-emergent adverse events (TEAEs) reported during the study were mild to moderate in severity, with no unexpected safety signals identified. Most adverse events were transient in nature and resolved without clinically significant intervention. Assessment of clinical laboratory parameters revealed no meaningful treatment-related changes and no patterns suggestive of adverse effects on haematology, clinical chemistry, or urinalysis evaluations. Likewise, there were no clinically relevant effects on electrocardiogram (ECG) parameters. No clinically meaningful changes were identified in vital signs, including blood pressure, heart rate, respiratory rate, body weight, or body temperature. Physical examination findings remained generally unchanged throughout the study, with no treatment-related abnormalities or trends of clinical concern noted. Overall, the safety and tolerability findings indicate that the Ropanicant was well tolerated, with no clinically meaningful effects on laboratory assessments, ECGs, vital signs, or physical examination findings, supporting its continued clinical development in patients with MDD. Detailed findings from the clinical study will be presented in future medical conference and/or peer-reviewed journal publications. On additional findings, use, method of treatment etc, a priority patent application has already been filed and an International Application claiming priority from the priority application will be filed in a few days. The study is a randomized, double-blind, placebo-controlled trial that enrolled 214 patients across 35 sites for a treatment duration of six weeks. The trial was conducted exclusively in the United States of America. The study evaluated the efficacy and safety of Ropanicant 45 or 30 mg administered twice daily in patients with MDD, compared with placebo administered twice daily, in improving symptoms of depression as measured by the MADRS. For more information about the Phase-2b study visit ClinicalTrials.gov. Identifier NCT06836063. Ropanicant is a novel, selective nicotinic a4ß2 receptor antagonist in development for MDD. It has shown strong efficacy in animal models of depression and may address key limitations of current treatments, including rapid onset of action, reduced sexual dysfunction, and enhanced cognitive function. Non-clinical safety has been established through extensive pharmacology and toxicity studies (up to 9 months). In Phase-1 trials, Ropanicant was safe and well tolerated at the highest doses, with no significant effects from food or age. The Phase-2a trial demonstrated a favorable safety profile and significant improvements in depressive symptoms, as measured by the MADRS score. Suven fully owns all the intellectual property rights of Ropanicant.
