Suven Life Sciences Completes FIH Phase-1 Study of SUVN-I6107, Advances Muscarinic M1 Modulator to Phase-2 Development

Suven Life Sciences Completes FIH Phase-1 Study of SUVN-I6107, Advances Muscarinic M1 Modulator to Phase-2 Development​

Suven Life Sciences Limited, a biopharmaceutical company focused on Central Nervous System (CNS) disorders, has announced the successful completion of the First-in-Human (FIH) Phase-1 clinical study for SUVN-I6107. The compound is a novel Muscarinic M1 Positive Allosteric Modulator (M1-PAM). The study demonstrated favorable safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics, supporting the company's decision to advance SUVN-I6107 into Phase-2 clinical development.

Phase-1 Study Overview and Scope

The completed FIH Phase-1 study (NCT06705088) was a two-part, randomized, double-blind, placebo-controlled evaluation of SUVN-I6107 in healthy human volunteers to assess its safety, tolerability, PK, and PD.

The research involved:

• Single Ascending Dose (SAD): Enrolled 40 participants across five cohorts and assessed food effects and potential sex-related differences in PK.
• Multiple Ascending Dose (MAD): Enrolled 24 participants across three cohorts, with participants receiving SUVN-I6107 or placebo daily for 14 consecutive days.

The study also utilized translational biomarkers to assess CNS activity, providing evidence of the compound's pharmacological effects on brain function and supporting its mechanism of action.

Key Phase-1 Study Findings

SUVN-I6107 exhibited a favorable safety and tolerability profile across all evaluated dose levels. There were no predefined dose-escalation stopping criteria met, and no treatment related adverse event resulted in drug discontinuation or participant withdrawal. No serious adverse events (SAEs) or deaths were reported during the study. All treatment emergent adverse events observed were mild to moderate in severity and resolved before study completion.

Pharmacokinetic and Pharmacodynamic Results

PK assessments showed predictable, dose-proportional kinetics, with exposure (Cmax and AUC) increasing proportionally with the increased dose. The compound demonstrated a median time to peak plasma concentration (Tmax) of approximately 2 to 6 hours and an mean elimination halflife (t½) of approximately 7 to 11 hours across the assessed dose range.

Crucially, PK exposures associated with projected therapeutic efficacy were achieved. Assessments indicated no clinically meaningful differences between male and female participants, suggesting that gender-based dose adjustment is unlikely to be necessary. Furthermore, food intake had no clinically relevant impact on the PK of SUVN-I6107, allowing for a flexible dosing regimen in future studies.

Pharmacodynamic biomarker assessments confirmed evidence of increased alertness and enhanced information processing, supporting the central pharmacological activity of SUVNI6107 and its effects on brain function.

Expert Commentary and Program Progression

Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, stated that the Phase-1 completion represents a significant development milestone for the M1-PAM program. As the fifth internally discovered candidate (NCE) to enter clinical development, SUVN-I6107 reflects the productivity of the organization's research efforts. He added that the company looks forward to progressing the program into Phase-2 clinical studies to evaluate its potential in areas of significant unmet medical need.

Mr. Ramakrishna Nirogi, President and Chief Scientific Officer of Suven Life Sciences, commented on the successful completion of the study. The data generated not only provide evidence of CNS activity but also support the advancement of SUVN-I6107 into Phase-2 clinical evaluation, thereby guiding future development plans.

About SUVN-I6107

SUVN-I6107 is a novel, potent, and selective muscarinic M1 positive allosteric modulator (M1-PAM) with minimal intrinsic agonist activity. It does not show significant affinity for muscarinic subtypes M2 to M5. The compound demonstrates excellent pharmacokinetic properties and good brain penetration, achieving high cerebrospinal fluid concentrations in rats. SUVN-I6107 has shown robust efficacy in animal models of cognition and possesses a wide margin of safety based on 28-day toxicity studies and anticipated efficacy. Suven Life Sciences holds the intellectual property rights for SUVN-I6107 in all major markets.

SUVEN Stock Price Movement​

Suven Life Sciences Limited's shares are slipping by 0.24% in live trading, currently registering at ₹269.20 as of 9:32 AM, down ₹0.65 from the previous close. The equity traded volume stands at 389,955 shares in this Live Market session.