First subjects dosed in Phase-1 clinical trial of Cognitive Disorder drug SUVN-I6107: Suven Life Sciences

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-01-09 07:00 GMT | Update On 2025-01-09 07:01 GMT

Hyderabad: Suven Life Sciences, a clinical stage biopharmaceutical company discovering and developing novel medicines to treat Central Nervous System (CNS) disorders, has announced that the first subjects have been dosed in a Phase-1 clinical trial of SUVN-I6107 being conducted in USA under FDA acceptance of Investigational New Drug (IND) and 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 extensive, fully-owned pipeline of oral small molecules to address large disease populations with significant unmet need in neuroscience.

The Phase-1 trial is a two-part randomized, 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 (Clinicaltrials.gov Identifier NCT06705088). 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 enroll approximately 24 subjects, randomized into 3 cohorts, each to receive SUVN-I6107 or placebo for 14 consecutive days.

The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs. 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, 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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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First subjects dosed in Phase-1 clinical trial of Cognitive Disorder drug SUVN-I6107: Suven Life Sciences

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