Suven Life Sciences’ SUVN-I6107 Receives FDA Approval for Phase 1 Trial

Suven Life Sciences Limited has announced that the United States Food and Drug Administration (US FDA) has given a nod to its Investigational New Drug (IND) application for SUVN-I6107, granting a “Study may proceed” letter to start a first-in-human Phase 1 clinical trial.

SUVN-I6107 is a novel muscarinic M1 receptor-positive allosteric modulator, which represents a potential breakthrough in treating dementia. Preclinical studies have demonstrated that SUVN-I6107 exhibits precognitive properties in various animal models, with the added advantage of lacking cholinergic side effects at effective doses. This suggests that SUVN-I6107 could offer a better efficacy and safety profile compared to existing cholinesterase inhibitors, which are the current standard of care.

The Phase 1 clinical trial will be conducted in two parts: a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD portion will involve approximately 40 healthy participants, randomised into 5 cohorts, each receiving varying doses of SUVN-I6107 or a placebo. The MAD portion will include around 24 participants, randomised into three cohorts, each receiving 14 consecutive days of SUVN-I6107 or placebo.

The primary objective of the trial is to assess the safety and tolerability of SUVN-I6107, monitored through adverse events (AEs), clinical laboratory results, vital signs, and electrocardiographs. Secondary objectives will focus on the pharmacokinetics of the drug, measured through plasma concentrations. Additionally, exploratory endpoints will investigate the effects of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potentials, among other metrics.

Suven Life Sciences is set to commence dosing in the second half of 2024, with an expected data readout in the first half of 2025. This trial marks a significant milestone in the development of SUVN-I6107, which could potentially address a major unmet need in the dementia treatment market.

About Suven Life Sciences Limited

Suven Life Sciences is focused on the discovery and clinical development of innovative medicines that address unattended medical requirements in central nervous system (CNS) disorders.

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