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IAMA Therapeutics Commences Phase 1 Clinical Trial for IAMA-6 in Autism and Epilepsy Treatment, Marking First Subject Dosage

Wednesday, January 24, 2024

IAMA Therapeutics, a pharmaceutical company dedicated to advancing medicines for children affected by brain disorders, has announced the initiation of the first-in-human trial for IAMA-6. This orally administered small molecule therapeutic targets NKCC1 and is currently undergoing evaluation for the treatment of autism and epilepsy in a Phase 1 clinical trial.

Andrea P. Malizia, CEO of IAMA Therapeutics, expressed pride in the launch of the Phase 1 trial, aiming to establish a safe dose range for the ongoing clinical development of IAMA-6. Malizia highlighted the potential impact of this treatment, deemed safe and well-tolerated in preclinical studies, on children and families grappling with central nervous system disorders such as autism and epilepsy. This milestone brings the company closer to fulfilling its commitment to address unmet medical needs in this patient population.

The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study involving single ascending doses (SAD) and multiple ascending doses (MAD) of IAMA-6. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of orally administered IAMA-6 in healthy adults.

IAMA-6, as the lead clinical program of IAMA, is a small molecule therapeutic designed to directly target and inhibit NKCC1-associated neuronal hyperexcitability. Elevated NKCC1 activity is implicated in various pathological conditions, highlighting the potential of NKCC1 inhibition in treating both idiopathic and secondary forms of autism (autism spectrum disorder, or ASD), refractory epilepsy, Dravet Syndrome, and other neurological disorders. Demonstrating safety and favorable tolerability in pre-clinical studies, IAMA-6 exhibits the capability to be applied across multiple central nervous system (CNS) indications.



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