Axial Therapeutics Expands Clinical Development Capabilities with Key Appointments

– Clinical development operations focused on ongoing Phase 2b clinical trial of AB-2004 in autism; data anticipated in 2023 –

– Team also supporting additional microbiome-based small molecule candidates in neurology and oncology indications –

WOBURN, Mass., Oct. 11, 2022 (GLOBE NEWSWIRE) — Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to the development of gut-targeted, small molecule therapeutics for neurological conditions and oncology, today announced that it is building on its clinical development science and operations capabilities through recent key appointments. These appointments include: Gabriel Belfort, MD, PhD, Vice President, Clinical Development Sciences and Operations, Kelly Bourdon, Head of Clinical Operations, Philinia Lehr RN, MSN, Head of Clinical Trial Recruitment and Margaret Nelson-Lowe, PhD, Associate Director, Clinical Operations.

“We are excited to be moving to this next stage of the company’s growth with the addition of these key clinical development team members as we advance our Phase 2b clinical trial for AB-2004 to treat irritability associated with autism,” said Stew Campbell, CEO of Axial Therapeutics. “Their proven expertise and experience will further strengthen our abilities as we advance additional microbiome-based small molecules toward the clinic in neurology and oncology indications particularly in Parkinson’s Disease. We welcome them to the Axial team.”

Dr. Gabriel Belfort joined Axial in June 2022. He is a central nervous system (CNS)-focused physician-scientist with neuroscience research expertise and more than a decade of industry experience dedicated to advancing the clinical development of novel medicines to treat CNS disorders. Gabriel received his MD and PhD from the Boston University School of Medicine, trained as a resident in Neurology at the Beth Israel Deaconess Medical Center and completed a postdoctoral fellowship in molecular and behavioral neuroscience at the Massachusetts Institute of Technology.

“The Axial team has a deep expertise in the gut-brain axis and its correlation to neurological diseases and disorders. This knowledge serves as the basis for a differentiated approach to developing microbiome-based target-specific small molecule therapeutics,” said Dr. Belfort. “I am excited to work with the team to investigate the clinical utility of our drug candidates leveraging a platform that has the potential to deliver new ways of treating an array of neuropsychiatric diseases as well as other therapeutic areas.”

About Axial Therapeutics
Axial Therapeutics is a clinical-stage biopharmaceutical company dedicated to improving the lives of people with neurological disorders and conditions. The company is a scientific leader in the biological role of the microbiome-gut-brain axis and its influence on the central nervous system. Harnessing its unique expertise in the microbiome, Axial is developing small molecule drugs with defined mechanisms of action that act on new targets to mitigate the impact of metabolites and bacteria in the gut linked to neurological disorders and disease pathology, progression, and symptoms. The company is advancing a pipeline of “microbial-inspired therapeutics™” for conditions with significant unmet patient need, including autism and Parkinson’s disease, and is also pursuing pre-clinical discovery of gut-targeted therapies in oncology. Axial’s lead product candidate is AB-2004, a molecular therapeutic in Phase 2b clinical trials for the treatment of irritability in children with autism. For more information, visit https://axialtx.com.

About AB-2004

AB-2004 is a first-in-class, molecular therapeutic that targets the microbiome gut-brain axis and its role in autism. AB-2004 has a unique mechanism of action that selectivity sequesters certain gut-derived metabolites before they enter the bloodstream and reach the brain. Axial believes this gut-targeted approach minimizes the potential for side effects in part due to a lack of systemic exposure to the drug. In a Phase 1b/2a clinical trial in adolescents with autism, AB-2004 was safe and well-tolerated and exhibited no drug-related serious adverse events. AB-2004 was also shown to reduce several microbial metabolites implicated in autism and showed evidence of improving key behaviors, including irritability and anxiety. A randomized, double-blind, placebo-controlled global Phase 2b clinical trial is currently ongoing to evaluate the efficacy, safety and tolerability of AB-2004. More information about the study can be found at www.theautismstudy.com.

CONTACT: Contacts for Axial Therapeutics

Media:
Mike Beyer
Red House Communications
312-961-2502
mikeb@theharbingergroup.com

Investors:
Jeffrey Young, CFO
781-701-8467
jeffrey@axialtx.com