IAMA Therapeutics Announces First Subject Dosed in Phase 1 Study of IAMA-6 for the Treatment of Autism and Epilepsy

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IAMA-6, IAMA’s lead program, is being evaluated for the treatment of autism and epilepsy in a Phase 1 first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study.

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Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Tuesday, January 23, 2024
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Tags: 
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, IAMA, Spectrum, Myenteric plexus, Epilepsy, NKCC1, DSM-IV codes, FIH, SAD, Therapy, Pharmaceutical industry
Geotags: 
EUROPE, UNITED STATES, ITALY, NORTH AMERICA, MAD
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Organisation: 
IAMA THERAPEUTICS, IAMA-6
Summary
Key Points: 
  • IAMA-6, IAMA’s lead program, is being evaluated for the treatment of autism and epilepsy in a Phase 1 first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study.
  • “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 program, IAMA-6,” stated Andrea P. Malizia, CEO of IAMA Therapeutics.
  • This significant milestone brings us one step closer to fulfilling our commitment to address the unmet medical needs in this patient population."
  • Initial interim data from this study is expected in June 2024.


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 first subject was treated with IAMA-6, an orally administered small molecule therapeutic targeting NKCC1. IAMA-6, IAMA’s lead program, is being evaluated for the treatment of autism and epilepsy in a Phase 1 first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study.

“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 program, IAMA-6,” stated Andrea P. Malizia, CEO of IAMA Therapeutics. “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."

Initial interim data from this study is expected in June 2024.

About the IAMA-6 Phase 1 Clinical Trial

The phase 1 clinical trial is a randomized, double blind, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study. The study will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.

About IAMA-6

IAMA-6, the lead clinical program of IAMA, is an orally administered small molecule therapeutic designed to directly target and inhibit NKCC1-associated neuronal hyperexcitability. The elevated activity of NKCC1 is implicated in various pathological conditions, underscoring the significant potential of NKCC1 inhibition in the treatment of both idiopathic and secondary forms of autism (autism spectrum disorder, or ASD), refractory epilepsy, Dravet Syndrome, and other neurological disorders. With the capability to be applied across multiple central nervous system (CNS) indications, IAMA-6 has demonstrated its safety and favorable tolerability in pre-clinical studies.

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 https://iamatherapeutics.com/

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