Suven Life randomizes first patient for CNS disorder treatment

Shares of Suven Life Sciences jumped more than 4 per cent after the company 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 program is being executed through Suven Neurosciences, Inc., wholly owned subsidiary of Suven Life Sciences.

The primary objective of the program 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 is to evaluate 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.

This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of 2 mg and 4 mg SUVN-G3031 compared with placebo in patients with narcolepsy with and without cataplexy. Patients will be randomized 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.

On Tuesday, stock of Suven Life closed at Rs 294.25, up by 3.6 per cent. During the day, it made intra day high and low of Rs 299 and Rs 283.30 respectively.