Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107, for treating cognitive disorders

Suven Life Sciences is discovering and developing novel medicines to treat Central Nervous System (CNS) disorders. The company announced that the first subjects have been dosed in a Phase-1 clinical trial of SUVN-I6107 being conducted in the US under FDA acceptance of Investigational New Drug (IND) and the issue of Study May Proceed letter. 

SUVN-I6107 is the fifth internally discovered compound to advance into clinical trials and an addition to Suven’s fully-owned pipeline of oral small molecules aimed at addressing large disease populations with significant unmet need in neuroscience. 

The Phase-1 trial is a two-part randomised, double-blind, placebo-controlled, single and multiple ascending oral dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects. Part-1 will be a single ascending dose (SAD) study, expected to enroll approximately 40 subjects across 5 cohorts. Part-2 will be a multiple ascending dose (MAD) study, expected to enrol approximately 24 subjects, randomized into 3 cohorts, each to receive SUVN-I6107 or placebo for 14 consecutive days. 

The study’s primary objective is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs. A secondary objective is to determine the pharmacokinetic profile of SUVN-I6107 in healthy subjects. Exploratory endpoints will examine the effects of SUVN-I6107 on changes in quantitative electroencephalogram and event-related potential parameters, the effect of food on pharmacokinetics of SUVN-I6107 and pharmacokinetic evaluation of SUVN-I6107 in cerebrospinal fluid. 

SUVN-I6107 is a novel, potent, and selective muscarinic M1 positive allosteric modulator with minimal agonist-like activity. It exhibits no significant affinity for muscarinic subtypes M2 to M5. SUVN-I6107 demonstrates excellent pharmacokinetic properties and good brain penetration, achieving high cerebrospinal fluid concentrations in rats. It has shown robust efficacy in animal models of cognition. Additionally, it has a wide margin of safety based on 28-day toxicity studies and anticipated efficacy. Suven Life Sciences owns the intellectual property rights for SUVN-I6107 in all major markets.