IAMA Therapeutics Announces Approval of Clinical Trial Application (CTA) by the Italian Medicines Agency (AIFA) to Initiate a Phase 1 Study of IAMA-6 for the Treatment of Autism and Epilepsy

2023-12-20

临床1期临床申请

GENOA, Italy--(BUSINESS WIRE)-- IAMA Therapeutics, a pharmaceutical company focused on the discovery, development, and commercialization of novel medicines for children affected by brain disorders, today announced that the Italian Medicines Agency (AIFA) has accepted the Clinical Trial Application (CTA) to initiate a Phase 1 first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA’s lead program IAMA-6, an orally administered small molecule therapeutic targeting NKCC1 for the treatment of autism and epilepsy. “We are proud to announce the first regulatory clearance for our lead program, IAMA-6, which has been shown to be safe and well-tolerated in preclinical studies,” said Andrea P. Malizia, Chief Executive Officer of IAMA Therapeutics. “Children living with central nervous system disorders, including autism and epilepsies, face significant unmet medical needs. This exciting milestone for IAMA-6 brings us one step closer to achieving our goal of making a meaningful impact on the individuals affected by these diseases and the families who care for them.” IAMA-6 has shown encouraging in vitro and in vivo proof of concept results in autism spectrum disorders and drug-resistant epilepsies. The compound is designed to directly target and inhibit NKCC1 and neuronal hyperexcitability. The Company expects to begin dosing healthy adults in the Phase 1 study in January 2024. About IAMA Therapeutics IAMA Therapeutics pushes the boundaries of neuroscience drug discovery to develop new therapeutic opportunities and make a difference in children affected by epilepsy, neurodevelopmental and cognitive disorders. IAMA Therapeutics is developing IAMA-6 for potentially treating drug-resistant epilepsies and autism spectrum disorders, in addition to other chloride modulators targeting neuropsychiatric conditions characterized by cognitive impairment. For more information, please visit .

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