Suven Life Sciences, a clinical stage biopharmaceutical company discovering and developing novel medicines to treat Central Nervous System (CNS) disorders, has announced the acceptance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) and grant of “Study may proceed Letter” to evaluate SUVN-I6107 in a first-in-human phase-1 clinical trial.

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects.

The FDA acceptance of the IND for SUVN-I6107 allows us to proceed with the Phase 1 study for this novel true muscarinic M1 receptor positive allosteric modulator, a potential new treatment to address the significant dementia market. Preclinical evidence has shown that treatment with SUVN-I6107 results in precognitive properties in diverse animal models. Additionally, SUVN-I6107 was devoid of cholinergic side effects at doses effective in animal models. Based on these results, SUVN-I6107 may have a better efficacy and safety profile than the currently available cholinesterase inhibitors due to its allosteric modulation of muscarinic M1 receptor. We look forward to dosing the first subject with SUVN-I6107 during the H2-2024 with an expected data readout in the H1-2025.

The Phase-1 trial is a 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. Part-1 will be a single ascending dose (SAD) study, expected to enroll approximately 40 participants, randomized into one of 5 planned cohorts. Part-2 will be a multiple ascending dose (MAD) study, expected to enroll approximately 24 participants, who will be randomized into 3 planned cohorts, each to receive 14 consecutive days of SUVN-I6107 or placebo.

The primary endpoint will assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs. Secondary endpoints include the pharmacokinetic evaluation of SUVN-I6107, assessed via plasma concentrations. Exploratory endpoints will examine the effects of SUVN-I6107 on quantitative electroencephalogram and event-related potential, among other measures.