India-based Suven Life Sciences has announced the dosing of the first subjects in its Phase I clinical trial of SUVN-I6107 to treat cognitive disorders.
The trial is being carried out in the US following the Food and Drug Administration’s (FDA) acceptance of the investigational new drug application.
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SUVN-I6107 is a muscarinic, M1 positive allosteric modulator (M1 PAM) and represents the fifth internally discovered compound by Suven to enter clinical trials.
The Phase I study is a two-part, double-blind, randomised, placebo-controlled trial designed to evaluate single and multiple ascending oral doses of SUVN-I6107.
It is evaluating the compound’s safety, tolerability, and pharmacokinetics in healthy participants.
Approximately 40 subjects across five cohorts are expected to participate in part one, which will be a single-ascending dose study. Part two will enrol nearly 24 participants in a multiple-ascending dose study, receiving the compound or a placebo for 14 consecutive days.
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By GlobalDataThe trial’s primary goal is to monitor the safety and tolerability of SUVN-I6107 by observing clinical laboratory results, adverse events, vital signs, and electrocardiographs.
Secondary objectives include determining the pharmacokinetic profile of the compound in healthy subjects.
Exploratory endpoints will investigate the effects on quantitative electroencephalograms and event-related potential parameters, as well as the impact of food on pharmacokinetics. In addition, it will also evaluate the pharmacokinetics of cerebrospinal fluid.
Suven has secured intellectual property rights for SUVN-I6107 in key markets globally.
In addition to SUVN-I6107, Suven’s clinical stage assets include Masupirdine (SUVN-502) for Alzheimer’s-related agitation, Samelisant (SUVN-G3031) for narcolepsy-related excessive daytime sleepiness, Ropanicant (SUVN-911) for major depressive disorder, and Usmarapride (SUVN-D4010) for cognitive disorders, among others.
The company also has eight research projects in progress, spanning several potential indications, with all intellectual property rights owned by Suven in major markets.
