Suven's Ropanicant Meets Primary Endpoint in Phase-2b Trial for Major Depressive Disorder
Hyderabad: Suven Life Sciences Limited has announced topline results from its Phase-2b clinical proof-of-concept trial evaluating Ropanicant, an investigational nicotinic α4β2 receptor antagonist, in patients with Major Depressive Disorder (MDD).
According to the company, the study met its primary endpoint, with twice-daily oral administration of Ropanicant 45 mg demonstrating a clinically meaningful improvement from baseline in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score at Week 6 compared to placebo.
The maximum likelihood (ML)-estimated mean difference from baseline versus placebo was reported as -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).
Suven Life Sciences stated that evidence of treatment benefit was also observed across several secondary endpoints, including the Clinical Global Impression–Severity of Illness (CGI-S) scale (p=0.094) and the Sheehan Disability Scale (SDS) (p=0.039). Improvements were additionally seen in the exploratory Quality of Life in Depression Scale (QLDS) (p=0.068).
The company noted that baseline demographic and clinical characteristics were comparable across placebo and treatment groups, indicating a balanced study population. Mean baseline scores for depression severity, global illness severity, functional impairment, quality of life, pleasure, and depressive symptoms were reported to be similar across all study arms.
On safety, Suven said Ropanicant was generally well tolerated among participants. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity, with no unexpected safety signals identified during the trial. The company reported that most adverse events were transient and resolved without clinically significant intervention.
The assessment of clinical laboratory parameters reportedly showed no meaningful treatment-related changes and no patterns suggesting adverse effects on haematology, clinical chemistry, or urinalysis evaluations. Similarly, no clinically relevant effects were observed on electrocardiogram (ECG) parameters.
The company further stated that no clinically meaningful changes were detected in vital signs, including blood pressure, heart rate, respiratory rate, body weight, or body temperature. Physical examination findings remained generally unchanged throughout the study.
Commenting on the results, Venkat Jasti, Chairman and Managing Director of 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."
Ramakrishna Nirogi, President and Chief Scientific Officer of Suven Life Sciences, added, "MDD is the leading cause of disability worldwide, and approximately 50% 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."
The company said detailed findings from the study will be presented at future medical conferences and/or published in peer-reviewed journals.
Suven also disclosed that a priority patent application covering additional findings, therapeutic use and treatment methods related to Ropanicant has already been filed. An international patent application claiming priority from the filing is expected to be submitted shortly.
