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Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

Advancement of first program from Axial platform into a randomized Phase 2b clinical trial signifies key milestone for company

Trial is enrolling approximately 195 autistic adolescents at clinical trial sites in the United States, Australia and New Zealand

Phase 2 trial is based on positive results from open-label Phase 1b/2a trial that demonstrated a favorable safety profile for AB-2004 as well as improvement in irritability scores

Excerpt from the Press Release:

WOBURN, Mass.–(BUSINESS WIRE)–Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to improving the lives of people with neurological conditions, today announced that the first subjects have successfully received their first dose in the company’s global Phase 2b clinical trial for lead candidate, AB-2004, a gut-targeted, molecular therapeutic that is being studied for alleviating the irritability associated with Autism Spectrum Disorder (ASD). The subjects received their first dose of either AB-2004 or placebo at CNS Healthcare in Orlando, FL and Optimal Clinical Trials in Auckland, New Zealand, respectively.

“In keeping with Axial’s mission to fundamentally improve the management of neurological conditions through our focus on the microbiome gut-brain axis, we are truly excited to progress the clinical development of AB-2004 with the dosing of our first subjects in this double-blinded Phase 2b study,” said A. Stewart Campbell, Ph.D., chief executive officer of Axial Therapeutics. “We are proud of our team for their continued commitment to improving the lives of children with autism, and thank the investigators at our global study sites for their collaboration in successfully advancing our first-in-class, molecular therapeutic into Phase 2 development.”

Approximately 1 in 54 children in the U.S. and 1 in 160 children worldwide have been identified with ASD according to the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO), respectively. Core traits of autism include altered social interaction, communication, and the presence of stereotyped repetitive behaviors. Co-occurring conditions that impact quality of life are extensive and diverse, and include irritability, anxiety, Attention Deficit Hyperactivity Disorder (ADHD), allergies, autoimmune disorder, neuroinflammation, and epilepsy. Physicians have reported that irritability impacts a majority of the autistic pediatric population. The presentation of irritability associated with autism can vary with severity and age and can be caused by a broad array of different factors, including lack of sleep, the inability to communicate pain and discomfort, and mental health conditions.

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