Suven Life Sciences has commenced a Phase 1 clinical trial in the United States for SUVN-I6107, a novel compound aimed at treating cognitive disorders. The trial, initiated following FDA acceptance of the Investigational New Drug (IND) application, marks a significant step in Suven's efforts to address unmet needs in neuroscience.
The Phase 1 trial is structured as a two-part, randomized, double-blind, placebo-controlled study. It will evaluate single and multiple ascending oral doses of SUVN-I6107 in healthy subjects. The primary objective is to assess the safety and tolerability of the compound, with secondary objectives focused on determining its pharmacokinetic profile.
Trial Design and Objectives
The trial is divided into two parts. Part 1 is a single ascending dose (SAD) study, involving approximately 40 subjects across five cohorts. Part 2 is a multiple ascending dose (MAD) study, with around 24 subjects randomized into three cohorts. Participants in the MAD study will receive either SUVN-I6107 or a placebo for 14 consecutive days.
Endpoints include monitoring adverse events, clinical laboratory results, vital signs, and electrocardiographs to evaluate safety and tolerability. The study will also explore the effects of SUVN-I6107 on quantitative electroencephalogram and event-related potential parameters, the impact of food on the drug's pharmacokinetics, and its pharmacokinetic profile in cerebrospinal fluid.
SUVN-I6107: A Novel Approach
SUVN-I6107 is a novel, potent, and selective muscarinic M1 positive allosteric modulator with minimal agonist-like activity. Preclinical studies have demonstrated its efficacy in animal models of cognition, and it exhibits excellent pharmacokinetic properties with good brain penetration, achieving high cerebrospinal fluid concentrations in rats. Suven Life Sciences holds the intellectual property rights for SUVN-I6107 in all major markets.
Suven's Pipeline and Focus
Suven Life Sciences is dedicated to discovering and developing innovative medicines for central nervous system (CNS) disorders. SUVN-I6107 is the fifth internally discovered compound to advance into clinical trials. Suven's pipeline includes other clinical-stage assets such as Masupirdine (SUVN-502) for Alzheimer's-related agitation, Samelisant (SUVN-G3031) for narcolepsy-related excessive daytime sleepiness, Ropanicant (SUVN-911) for major depressive disorder, and Usmarapride (SUVN-D4010) for cognitive disorders.
