Axial Biotherapeutics Doses First Patient in Ph Ib-IIa Trial of AB-2004 for Treatment of Autism Related GI Dysfunction and Behavioral Symptoms

July 18, 2019

Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, announced on 7/16/19 the dosing of the first patient in its Phase 1b/2a clinical trial of AB-2004. In animal models, AB-2004 has demonstrated the ability to repair leaky gut and improve repetitive behavior, anxiety and Autism Spectrum Disorder (ASD)-related sensorimotor gating deficits by removing key microbial metabolites.

“The dosing of the first patient in the Phase 1b/2a clinical trial of AB-2004 is an important milestone for Axial as we advance this program further into the clinic. ASD is an indication that currently has no approved therapies for the treatment of the core symptoms. We believe that AB-2004 has the potential to be a first-in-class drug targeting gastrointestinal (GI) symptoms and core behavioral symptoms,” said David H. Donabedian, Ph.D., co-founder and CEO of Axial Biotherapeutics. “The Axial hypothesis proposes that altered microbial metabolites may drive GI and behavioral symptoms in ASD subjects. We look forward to collecting Phase 1b/2a results to further study the potential of AB-2004 and its impact on improving GI and behavioral symptoms associated with ASD.”

The Phase 1b/2a clinical trial is designed to examine the safety and tolerability of AB-2004 in up to 25 male adolescent subjects with ASD. Exploratory endpoints include changes in bacterial metabolite levels, GI function, gut microbiome and behavior.

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