Suven Life Sciences announced the successful completion of the Phase-1 first-in-human (FIH) clinical study for SUVN-I6107, a novel muscarinic M1 positive allosteric modulator (M1-PAM), on June 16, 2026. The study results demonstrated a favorable safety and tolerability profile with no dose-limiting toxicities, alongside robust pharmacodynamic activity indicating central nervous system (CNS) engagement. These findings support the advancement of SUVN-I6107 into Phase-2 clinical development, marking a significant milestone in the company's pipeline for treating CNS disorders.

The randomized, double-blind, placebo-controlled study (NCT06705088) was conducted in two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD). The SAD segment enrolled 40 participants across five cohorts, assessing food effects and sex-related differences. The MAD segment enrolled 24 participants across three cohorts, with daily dosing for 14 consecutive days. Translational biomarkers were incorporated to assess CNS activity and confirm the compound's mechanism of action.

Key Study Findings

SUVN-I6107 exhibited predictable, dose-proportional pharmacokinetics, achieving projected therapeutic exposures in plasma and at the target site. The median time to peak plasma concentration was approximately 2–6 hours, with a mean elimination half-life of 7 to 11 hours. Pharmacokinetic assessments showed no clinically meaningful differences between male and female participants, and food intake had no clinically relevant impact on the drug's profile. Pharmacodynamic biomarker assessments indicated increased alertness and enhanced information processing.

Safety data indicated that no predefined dose-escalation stopping criteria were met, and no treatment-related adverse events led to discontinuation. No serious adverse events or deaths were reported, with all observed events being mild to moderate and resolving prior to study completion.

Management Commentary

Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, highlighted the significance of the milestone. "The completion of the Phase-1 study for SUVN-I6107 represents an important development milestone for the M1-PAM program and further expands our clinical-stage pipeline in neuroscience," he said. Mr. Ramakrishna Nirogi, President and Chief Scientific Officer, added that the data provides evidence of CNS activity and supports the transition to Phase-2 evaluation.

SUVN-I6107 is the fifth internally discovered candidate to enter clinical development for Suven Life Sciences. The company retains intellectual property rights for the asset in all major markets.

Suven Life Sciences Limited will present three posters detailing the clinical advancement of Samelisant (SUVN-G3031) at the SLEEP-2026 Annual Meeting in Baltimore, USA. The presentations, scheduled for June 14-17, 2026, will highlight positive Phase-2 efficacy data in excessive daytime sleepiness (EDS), the rationale for a Phase-2 study in cataplexy, and the Phase-3 development strategy for narcolepsy. The SLEEP meeting is the 40th annual conference of the Associated Professional Sleep Societies (APSS), a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.

The first poster, scheduled for June 15, 2026 (Poster # 374), will demonstrate the significant reduction in EDS in patients with narcolepsy based on Phase-2 results. Also on June 15, a second presentation (Poster # 368) will outline the study design and rationale for a Phase-2 trial of Samelisant for treating cataplexy in Type 1 narcolepsy. The third poster, set for June 16, 2026 (Poster # 332), will cover the Phase-3 clinical development, rationale, and study design for treating EDS in narcolepsy patients.

Samelisant is one of five clinical-stage assets in Suven Life Sciences 's portfolio focused on Central Nervous System (CNS) disorders. The company's pipeline includes Masupirdine (SUVN-502) for agitation in Alzheimer's disease, which is in a global Phase-3 study, and Ropanicant (SUVN-911) for Major Depressive Disorders. Suven retains all intellectual property rights for its assets across major markets.

Poster Presentations

Members of the Suven scientific team will hold meetings at Exhibit Booth # 1034 with Phase-3 study Principal Investigators, Key Opinion Leaders (KOLs), and potential partnering companies during the conference.