31 May 2019 - - US-based biotechnology company Axial Biotherapeutics is highlighting the publication of new findings in Cell by Sarkis K. Mazmanian, Ph.D., the company's scientific co-founder, and California Institute of Technology (Caltech) researchers, demonstrating that the colonization of germ-free mice with gut microbiota from human donors with Autism Spectrum Disorder induces hallmark behaviors of ASD as compared to control, typically-developing gut microbiota, the company said.
The publication, entitled "Human Gut Microbiota from Autism Spectrum Disorder Promote Behavioral Symptoms in Mice," is the first to suggest a direct link between gut microbiota and the pathophysiology and behavioral outcomes of ASD.
This link further supports Axial Biotherapeutics' foundational scientific rationale, suggesting that the gut microbiome regulates behavior in mice via the production of neuroactive metabolites.
In November 2016, Axial Biotherapeutics entered into a license agreement with Caltech for worldwide exclusivity to related intellectual property in applications for neurological diseases and disorders. Patient screening for the Phase 1b/2a clinical trial of AB-2004 was initiated in the first quarter of 2019.
According to the Center for Disease Control about 1 in 59 children has been identified with ASD. Core symptoms of ASD include impairments in social interaction, communication and the presence stereotyped repetitive behaviors.
Comorbidities are extensive and diverse, and include gastrointestinal 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.
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.