Suven Life Sciences announces the randomisation of first patient in the Phase-2 clinical trial of Ropanicant (SUVN-911) for the treatment of moderate to severe Major Depressive Disorder (MDD) study in US. The trial is a multicenter, randomised, open-label, parallel-group study planned across 10 sites in the US.
The study will enroll approximately 36 patients who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for MDD without psychotic features and a diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI). Patients will be randomised in a 1:1:1 ratio (12 patients in each treatment group) to receive ropanicant either 45 mg once a day, 30 mg twice a day, or 45 mg twice a day. Following a screening period of up to 4 weeks, the patients will be treated for two weeks.
The primary objective is to evaluate the safety and tolerability of ropanicant in patients with MDD. The secondary objective (efficacy objective) is to assess the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 2.
Topline data from the trial is expected to be available by Oct 2024. Additional information on the trial can be found at ClinicalTrials.gov Identifier NCT06126497.
About Ropanicant (SUVN-911)
Ropanicant, a novel, potent, and selective α4β2 nAChR antagonist, is being developed for the treatment of MDD. Ropanicant has shown robust efficacy in various animal models of depression. Ropanicant addresses major limitations of current depressive disorder therapeutics by offering rapid onset of action, does not cause sexual dysfunction, and shows pro-cognitive effects. Ropanicant non-clinical safety has been established in various safety pharmacology and toxicity studies (up to 9-month duration). In the first in human study, ropanicant was tested in healthy subjects in two phase-1 studies (NCT03155503 and NCT03551288). It was well tolerated up to the highest tested dose in both single dose and multiple dose studies. No significant effect of food and age was noted on ropanicant pharmacokinetics. Ropanicant intellectual property rights are well protected in all major markets.