Suven Life Sciences has announced the successful completion of phase 1 first-in-human clinical study of SUVN-I6107, a novel, potent, and highly selective muscarinic M1 Positive Allosteric Modulator (M1-PAM). The study demonstrated favorable safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, supporting the advancement of SUVN-I6107 into phase 2 clinical development.

The completed first-in-human phase 1 study (NCT06705088) was a two-part, randomised, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SUVN-I6107 in healthy human volunteers. The Single Ascending Dose (SAD) segment enrolled 40 participants across 5 cohorts and included assessments of food effects and potential sex-related differences in PK.

The Multiple Ascending Dose (MAD) segment enrolled 24 participants across three cohorts, with participants receiving SUVN-I6107 or placebo daily for 14 consecutive days. The study also incorporated translational biomarkers to assess CNS activity, providing evidence of the compound's pharmacological effects on brain function and supporting its mechanism of action.

SUVN-I6107 demonstrated a favorable safety and tolerability profile across all dose levels evaluated in the study. No predefined dose-escalation stopping criteria were met, and no treatment related Adverse Event (AE) led to study drug discontinuation or participant withdrawal. Importantly, no Serious Adverse Events (SAEs) or deaths were reported. All treatment-emergent AEs observed during the study were mild to moderate in severity and resolved prior to study completion.      

SUVN-I6107 demonstrated predictable, dose-proportional pharmacokinetics, with exposure (Cmax and AUC) increasing with increase in dose. The compound exhibited a median time to peak plasma concentration (Tmax) of approximately 2-6 hours and a mean elimination halflife (t½) of approximately 7 to 11 hours across the evaluated dose range.

Importantly, PK exposures associated with projected therapeutic efficacy were achieved. PK assessments showed no clinically meaningful differences between male and female participants, indicating that dose adjustment based on gender is unlikely to be necessary. Food intake also had no clinically relevant impact on the PK of SUVN-I6107, supporting a flexible dosing regimen that can be administered irrespective of meals in future studies.

Venkat Jasti, Chairman and Managing Director, Suven Life Sciences, said, “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. As the 5^th internally discovered candidate (NCE) to enter clinical development, SUVN-I6107 reflects the productivity of our research organisation and our continued focus on advancing differentiated CNS therapies. We look forward to progressing the program into phase 2 clinical studies and further evaluating its potential in areas of significant unmet medical needs."

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

Ramakrishna Nirogi, President and Chief Scientific Officer, Suven Life Sciences, said, “The successful completion of this first-in-human study marks an important milestone in the clinical development of SUVN-I6107. The study incorporated translational biomarkers, alongside comprehensive evaluations of safety, tolerability, pharmacokinetics, and pharmacodynamics. The data generated provided the evidence of CNS activity, support the advancement of SUVN-I6107 into phase 2 clinical evaluation, and will help guide future development plans.”