First patient randomised in a Phase 2A, Proof of Concept (PoC) clinical trial of SUVN-G3031

Suven Life Sciences, a clinical stage biopharmaceutical company developing novel medicines to treat life-threatening Central Nervous System (CNS) disorders, has announced dose administration of the first patient in a Phase 2A clinical trial of SUVN G-3031, a Histamine H3 receptor inverse agonist in a Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of 2 mg and 4 mg SUVN-G3031 compared to Placebo in patients with Narcolepsy with or without Cataplexy.

The clinical development programme being executed through Suven Neurosciences, Inc, a Delaware Company in USA, is a wholly owned subsidiary of Suven Life Sciences.

The primary objective of the trial is to evaluate the effectiveness of SUVN-G3031 compared with Placebo as measured by an improvement in the Maintenance of Wakefulness Test (MWT) score.

The secondary objective involves evaluation of the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the change in total Epworth Sleepiness Scale (ESS) score.

Patients will be randomised at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo, a total of 114 patients (38 per treatment group). This may be increased following a sample size re-estimation up to a maximum of 171 patients. Each patient will be dosed for 14 days.

Primary endpoint: Change from baseline in the mean MWT score at Day 14

Investigational Therapy : 2 mg SUVN-G3031 and 4 mg SUVN-G3031

The study is expected to last a total of 12-15 months.