Suven Life Sciences announced topline results from the phase 2b clinical proof-of-concept trial of Ropanicant for Major Depressive Disorder (MDD). Ropanicant is an investigational nicotinic α4β2 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). 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 (AEs) 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 AEs on hematology, 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.

Venkat Jasti, Chairman and Managing Director (MD), Suven Life Sciences, said, “We are very excited to announce Ropanicant phase 2b outcome, demonstrating clinically meaningful treatment benefits highlighting Ropanicant potential as a promising treatment for MDD. There is still a significant unmet medical need despite the availability of multiple approved therapies for MDD. We strongly believe that Ropanicant would offer differentiated treatment option to meet the unmet medical need.”

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.”

Ramakrishna Nirogi, President and CSO, Suven Life Sciences, said, “MDD is the leading cause of disability worldwide, and approximately 50 percent of patients do not adequately benefit from standard first-line antidepressant therapies. The phase 2b data strongly supports the potential of Ropanicant as a promising treatment for MDD. We look forward to engaging with regulatory authorities worldwide to discuss phase 3 clinical development plans of Ropanicant.”