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Axial Biotherapeutics Presents New Preclinical Data from AB-2004 Program Demonstrating Reduction of Microbiome-Derived Metabolites in Mouse Models with Autism Spectrum Disorder at the International Society for Autism Research (INSAR) 2019 Annual Meeting

May 2, 2019

WALTHAM, Mass.--(BUSINESS WIRE)--May 2, 2019--Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, presented new preclinical data on AB-2004, its orally administered, drug candidate that has demonstrated the ability to repair leaky gut and improve repetitive behavior, anxiety, and ASD-related sensorimotor gating deficits by removing key microbial metabolites in animal models with Autism Spectrum Disorder (ASD). The Company presented the data in a poster presentation at the International Society for Autism Research (INSAR) 2019 Annual Meeting in Montreal, Canada.

“We are pleased to present additional preclinical data which substantiates the potential of our platform to remove microbial based metabolites, by which we can restore gastrointestinal (GI) function and improve behavior associated with CNS and gut-derived diseases,” said David H. Donabedian, Ph.D., Co-founder and CEO of Axial Biotherapeutics. “We believe that altered microbial metabolite profiles can drive ASD symptoms, including behavior abnormalities, leaky gut and other GI issues. We believe that AB-2004 has the potential to alter these symptoms and we look forward to continuing patient screening for our Phase 1b/2a program and progressing this product further into the clinic.”

The main highlights from the poster presentation titled, “Characterization of GI barrier integrity and gut microbiome-derived metabolites in BTBR, Shank3 and Cntnap2 mouse models of ASD and demonstration of AB-2004 as a potential mitigating therapeutic” include:

Axial is currently screening ASD adolescents for its Phase 1b/2a clinical trial of AB-2004.

About Autism Spectrum Disorder

According to the Center for Disease Control (CDC) about 1 in 59 children has been identified with ASD. Core symptoms of ASD include impairments in social interaction, communication and the presence of stereotyped repetitive behaviors. Comorbidities are extensive and diverse, and include gastrointestinal (GI) disfunction, metabolic abnormalities, allergies, autoimmune disorders, neuroinflammation and epilepsy. GI disfunction is estimated to occur in 40-70% of individuals with ASD. The medical severity of core and non-core ASD symptoms, and the lack of safe and effective long-term treatments argue strongly for pursuing fundamentally new measures to address this significant unmet medical need.

About Axial Biotherapeutics

Axial Biotherapeutics is a clinical stage biopharmaceutical company pioneering novel science focused on the interaction between the brain and the gut to mitigate the causes and symptoms of CNS and other gut-derived diseases. The Company has built a pipeline of novel small-molecules and live biotherapeutics with lead programs to address the significant unmet patient needs associated with Parkinson’s Disease and Autism Spectrum Disorder. To learn more, visit https://www.axialbiotherapeutics.com/.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190502005560/en/

CONTACT: Investor:

Julie Seidel

Stern Investor Relations

(212) 362-1200

Julie.Seidel@sternir.com

KEYWORD: UNITED STATES NORTH AMERICA CANADA MASSACHUSETTS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH OTHER SCIENCE SCIENCE GENERAL HEALTH

SOURCE: Axial Biotherapeutics

Copyright Business Wire 2019.

PUB: 05/02/2019 11:00 AM/DISC: 05/02/2019 11:00 AM

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