IAMA Therapeutics has treated the first subject in the Phase I clinical trial of IAMA-6, a small molecule therapeutic aimed at treating autism spectrum disorder and epilepsy.

The first-in-human, randomised, placebo-controlled, double-blind trial will have single ascending dose and multiple ascending dose phases.

It will evaluate the tolerability, safety, pharmacokinetics, pharmacodynamics and the effect of food on the oral administration of IAMA-6 in healthy adult participants.

A lead clinical programme of the company, IAMA-6 is designed to act on and hinder NKCC1-associated neuronal hyperexcitability, a condition associated with various neurological disorders.

The hindering of NKCC1 has shown potential in treating both idiopathic and secondary forms of autism, refractory epilepsy, Dravet Syndrome and other neurological conditions.

The company anticipates reporting the preliminary interim data from the ongoing trial in June 2024.

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Prior to this trial, IAMA-6 has already established a safety profile and favourable tolerability in pre-clinical studies, suggesting its potential as a cross-indication central nervous system therapeutic.

IAMA Therapeutics focuses on creating new treatment options for children impacted by epilepsy, neurodevelopmental and cognitive diseases.

The development of IAMA-6 is part of a broader initiative to address drug-resistant epilepsies and autism spectrum disorders, as well as other neuropsychiatric conditions characterised by cognitive impairment along with chloride modulators.

IAMA Therapeutics CEO Andrea Malizia said: “We are proud to announce the commencement of the first-in-human trial aimed at establishing a safe dose range for the continued clinical development of our lead programme, IAMA-6.

“This treatment, proven to be safe and well-tolerated in preclinical studies, holds the promise of making a genuine and meaningful impact on children and families grappling with central nervous system disorders, including autism and epilepsies.

“This significant milestone brings us one step closer to fulfilling our commitment to address the unmet medical needs in this patient population.”