First patient randomized in Ropanicant Phase 2b trial for Major Depressive Disorder: Suven Life Sciences

Hyderabad: Suven Life Sciences has announced that the first patient has been randomized in its Phase-2b clinical trial evaluating Ropanicant, a novel oral α4β2 nicotinic acetylcholine receptor (nAChR) antagonist, for the treatment of Major Depressive Disorder (MDD).

The Phase-2b double blinded, placebo controlled study builds on the positive results of the completed Phase-2a trial, which demonstrated favorable safety, clinically meaningful and significant improvement in depressive symptoms from baseline based on the MontgomeryÅsberg Depression Rating Scale (MADRS) score, with indication of rapid onset of action in MDD patients distinguishing Ropanicant from existing standard therapies. Insights from Phase-2a evolved the study design, dose selection, and dosing regimen for the current Phase2b trial being conducted in exclusively in USA under FDA IND.

“Randomizing the first patient in our Phase-2b study of Ropanicant is an important milestone for Suven Life Sciences. It reflects our continued commitment to developing innovative treatments for patients suffering from MDD.” said Mr. Venkat Jasti, Chairman and MD of Suven Life Sciences.

“There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated. Ropanicant, with its unique, novel mechanism of action as an α4β2 antagonist, combined with its rapid onset, no sexual side effects, potential pro-cognitive benefits, achieves the position as a first-in-class, differentiated clinical candidate that could reshape the approach to the treatment of Major Depressive Disorders (MDD),” said Mr. Ramakrishna Nirogi, Ph. D., President & Chief Scientific Officer of Suven Life Sciences.

Ropanicant has shown robust efficacy in various animal models of depression. Ropanicant may have potential to overcome significant limitations of existing treatments for depressive disorders by providing a rapid onset of action, avoiding sexual dysfunction, and enhancing cognitive functions. Ropanicant non-clinical safety has been established in various safety pharmacology and toxicity studies (up to 9-month duration). Ropanicant was evaluated in healthy subjects in two Phase-1 studies (NCT03155503 and NCT03551288). It was well tolerated up to the highest tested dose in both single and multiple ascending dose studies. No significant effect of food and age was noted on Ropanicant pharmacokinetics. Ropanicant intellectual property rights are owned by Suven and are well protected in all major markets.