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Axial Therapeutics Receives Second Research Grant Award from The Michael J. Fox Foundation to Further Support Advancement of AX-5006 for Parkinson’s Disease

–Grant supports the continued preclinical development of AX-5006, a small molecule, gut-restricted amyloid inhibitor for symptomatic treatment and modification of disease in PD –

–IND-enabling studies ongoing to support Phase 1 clinical trial initiation in 2024 –

WOBURN, Mass.— June 20, 2023 — Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to the development of gut-targeted, small molecule therapeutics for neurological conditions and oncology, today announced it has received a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) through its Therapeutic Pipeline Program. The funding will support further preclinical development to assess the therapeutic efficacy of AX-5006, a small molecule, gut-restricted amyloid inhibitor for symptomatic treatment and modification of disease in Parkinson’s disease (PD). IND-enabling studies of AX-5006 are ongoing to support initiation of a Phase 1 clinical trial in 2024.

Parkinson’s disease affects 6 million people worldwide and is the second-leading neurodegenerative disease. While there are current treatments for PD that offer symptomatic relief, there are no FDA-approved therapeutics to slow disease progression or address the underlying disease mechanisms. In preclinical research, Axial has established that certain gut bacteria, specifically through the production of bacterial amyloids, contribute to gastrointestinal (GI) symptoms, motor symptoms, and disease pathology in PD. AX-5006 is designed to reduce bacterial amyloid aggregation in the gut, thereby alleviating symptoms and attenuating disease progression, and being gut-targeted, it is anticipated to have a favorable safety profile.

“We are proud to have continued funding support from The Michael J. Fox Foundation, the world’s largest nonprofit funder of PD research, to support the Axial team’s progress in the development of AX-5006 for the treatment of PD,” said Stewart Campbell, CEO of Axial Therapeutics. “Based on its mechanism of action, AX-5006 has the short-term potential to alleviate constipation, a major GI symptom in most cases of PD, and the long-term potential to favorably alter the course of disease progression. If successful, AX-5006 would establish a new class of meaningful treatment options for the PD population.”

“The Michael J. Fox Foundation aims to identify and develop programs with the potential to make an impact for those living with Parkinson’s disease,” said Luis Oliveira, PhD, Senior Associate Director of Research Programs, MJFF. “We are pleased to grant Axial a second funding award to support their research towards this goal.”

The MJFF Therapeutic Pipeline Program is open to industry and academic investigators proposing novel approaches or repositioning approved or clinically safe therapies from other disease indications. The Therapeutic Pipeline Program advances Parkinson’s disease therapeutic and intervention development along the pre-clinical and clinical path.

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 and NASH/fibrosis. 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.

Contacts for Axial Therapeutics

Media:
Maura Gavaghan
Red House Communications
maura@redhousecomms.com

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