Gut-Brain Axis Therapeutics is developing microbiota transplant therapy for treating gut-brain disorders in autism and related conditions. The company’s founding is deeply personal. Dr. James Adams, who leads the organization, has a daughter with autism, which motivated him 25 years ago to focus his research on treatments for the condition. 15 years ago, he led a study which demonstrated that gastrointestinal symptoms strongly correlated with autism symptoms, and that children with autism were missing beneficial bacteria and had harmful yeast. That led to their first clinical trial of microbiota transplant, which was very successful and led to 5 more, with the last 2 funded by Gut-Brain Axis Therapeutics.
What Key Challenge Is Gut-Brain Axis Therapeutics Focused on Addressing?
Autism now affects 1 in 31 children in the US, and there is no FDA-approved treatment for the core symptoms. The impact extends well beyond childhood. Most adults with autism are unemployed or underemployed and unable to live independently. Many suffer from loneliness, leading to depression. For families navigating this without access to effective treatment options, the challenges are lifelong.
How Is Gut-Brain Axis Therapeutics’ Approach Making a Meaningful Impact?
Their clinical trials have demonstrated substantial improvements in gastrointestinal symptoms and autism symptoms, with improvements generally continuing at 2 years post-treatment. The results have been meaningful across all ages. One 10-year-old boy started the study with only single-word sentences, and 7 months later was talking in 4 to 6-word sentences. Across their trials, they have seen children and adults improve in core autism symptoms, including language, social interaction, and behavior, as well as in many co-occurring symptoms such as gut issues, anxiety, irritability, self-injury, and sleep. The most common comment from families is that their child is happier after treatment.
How Has Being Based in Arizona Supported Their Growth, Innovation, or Progress?
Their clinical trials are conducted at ASU, which has been a cornerstone of their research. Beyond that, their annual Zoowalk for Autism Research at the Phoenix Zoo has been a key fundraiser supporting their early research and helping build community awareness around their mission.
What Does the Future Look Like for Gut-Brain Axis Therapeutics?
They are now raising funding for their final phase 3 studies to achieve FDA approval of microbiota transplant therapy for autism and related conditions. FDA approval would make the treatment available for everyone and would likely mean insurance coverage for the cost. They hope to have approval in 3 years or less if they are able to raise the funds needed for their final phase 3 clinical trial.
,
About the Author
Ava Woods is the Marketing & Communications Intern at AZBio, supporting digital communications, content creation, and member engagement initiatives. In her role, Ava assists with social media management, marketing campaigns, event promotion, and storytelling efforts that highlight Arizona’s growing bioscience community. Connect with Ava
About AZBio Member Spotlights
AZBio Member Spotlights are just one of the ways AZBio is building awareness of the health innovations being developed and delivered across the state of Arizona. Telling Arizona’s Bioscience Story is a key goal of Arizona’s Bioscience Roadmap, the nation’s longest-running statewide strategic plan designed to build a robust bioscience sector. Share and enjoy!