WOBURN, Mass.--(BUSINESS WIRE)--Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to improving the lives of people with neurological disorders and conditions, today announced that its scientific founder and California Institute of Technology (Caltech) Professor, Sarkis Mazmanian, Ph.D., will be presenting at TACA’s Autism Action Conference, taking place virtually from April 8-9, 2022. The presentation titled, “Gut-Brain Axis: How substances produced by the microbiome may contribute to Autism Spectrum Disorder,” will be held on Saturday, April 9 from 1:00-2:00 pm PST.
Dr. Mazmanian, Ph.D., Luis B. and Nelly Soux Professor of Microbiology and Heritage Medical Research Institute Investigator at Caltech, is a leader in the field of microbiology, the interaction between the gut microbiome and the brain, and the impact of this gut-brain axis on neurological disorders and conditions. His groundbreaking work established several key concepts in the biology of the gut-brain axis and its influence on complex behaviors and brain function, including how the gut microbiome may impact certain characteristics in people with Autism Spectrum Disorder (ASD). This research serves as the foundation for Axial Therapeutics’ potential new treatment, AB-2004, for managing irritability associated with ASD in children.
The data being presented by Prof. Mazmanian at the TACA conference draw from recently published articles in the February 14 editions of Nature Medicine and Nature. The Nature publication, led by Prof. Mazmanian, reported on preclinical research that found microbial metabolites produced by gut bacteria commonly found in the gastrointestinal (GI) tract can impact brain activity and influence complex behaviors in mice. The Nature Medicine article, a collaborative effort between Axial and Caltech led by A. Stewart Campbell, Ph.D., chief executive officer and head of Research & Development for Axial Therapeutics, highlights the first translation of the preclinical findings into a population with ASD. It provides mechanistic evidence supporting the potential of AB-2004 as a novel therapeutic approach for treating co-occurring conditions associated with ASD, including irritability and anxiety, that can severely impact the quality of life of children with autism.
To register and learn more about the TACA conference, visit https://tacanow.org/conferences/autism-action-conference/. Access to the recording of Dr. Mazmanian’s presentation will be made available on the Newsroom section of Axial’s website.
About AB-2004
AB-2004 is a first-in-class, molecular therapeutic that targets the microbiome gut-brain axis and its role in co-occurring conditions associated with ASD. AB-2004 has a unique mechanism of action that selectively 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.
About The TAPESTRY Study
Axial is evaluating AB-2004 in the TAPESTRY study, a global, randomized, double-blind, placebo-controlled Phase 2b clinical trial to assess the efficacy, safety, and tolerability of the drug in children aged 13 to 17 who have been diagnosed with ASD and exhibit high irritability. The study will enroll an estimated 195 patients who will receive low or high doses of AB-2004 or placebo. More information is available at www.theautismstudy.com or clinicaltrials.gov, identifier NCT04895215.
About Autism Spectrum Disorder (ASD)
According to the Centers for Disease Control and Prevention (CDC), approximately 1 in 44 children has been identified with ASD. Core features of ASD include impairments in 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. Among these is irritability, which can be extremely challenging to manage, involving behavioral issues such as aggression, self-injury, severe tantrums, emotional meltdowns, and need for isolation. Based on research, of the 1.1 million children with ASD in the United States, as many as 50% seek treatment to manage irritability. Physicians have reported that irritability impacts a large portion of children with ASD. The presentation of ASD-associated irritability 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 mental health conditions.
About The Autism Community in Action (TACA)
The Autism Community in Action (TACA) is a national nonprofit 501(c)(3) organization founded in 2000 with the mission to provide education, support and hope to families living with autism. Headquartered in Irvine, Calif. with staff and volunteers working across the country annually serving over 75,000 families and adding 700 new families every month. TACA holds two annual National Autism Conferences hosted on the west and east coasts. For more information visit www.tacanow.org.
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.
