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.