SUVN-I6107, the fifth internally discovered compound from Suven to progress into clinical trials, represents a promising addition to the company's broad, fully-owned pipeline of oral small molecules designed to address major disease areas with significant unmet needs in neuroscience.
The Phase 1 trial is a two-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy participants.
The first part is a single ascending dose (SAD) study, enrolling approximately 40 subjects across five cohorts. The second part is a multiple ascending dose (MAD) study, which will include around 24 subjects, randomized into three cohorts, each receiving SUVN-I6107 or a placebo for 14 consecutive days.
The primary objective of the trial is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory results, vital signs, and electrocardiograms. The secondary objective is to determine the pharmacokinetic profile of the compound in healthy participants. Exploratory endpoints will evaluate the effects of SUVN-I6107 on changes in quantitative electroencephalogram and event-related potential parameters, the impact of food on its pharmacokinetics, and the compound's pharmacokinetic properties in cerebrospinal fluid.
Suven Life Science is a biopharmaceutical company focused on discovering, developing, and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies using GPCR targets.
The company reported net loss of Rs 49.64 crore in Q2 FY25 as against net loss of Rs 12.68 crore in Q2 FY24. Net sales declined 16% YoY to Rs 2.57 crore in the September 2024 quarter.