Suven Life Sciences, a clinical stage biopharmaceutical company that discovers and develops novel medicines to treat Central Nervous System (CNS) disorders, has recently announced that the United States Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application and granted a “Study may proceed Letter” to evaluate SUVN-I6107 in a first-in-human phase-1 clinical trial.
In the filing, the company shared, “The FDA acceptance of the IND for SUVN-I6107 allows 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 statement further reads that the purpose of the Phase-1 trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects. It is a randomized, double-blind, placebo-controlled research using single and repeated ascending oral doses. Part 1 will be a single ascending dose (SAD) study with roughly 40 individuals randomly assigned to one of five 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 main endpoint will evaluate SUVN-I6107’s safety and tolerability by monitoring adverse events (AEs), clinical laboratory results, vital signs and electrocardiographs. Secondary endpoints include SUVN-I6107’s pharmacokinetic assessment using plasma concentrations. Exploratory endpoints will examine the effects of SUVN-I6107 on quantitative electroencephalogram and event-related potential, among other measures.
