A new therapeutic microbiome company was officially launched on Wednesday, with the help of a $19.15 million Series A financing round led by Longwood Fund and Domain Associates.
According to the company news release, Axial Biotherapeutics aims to indirectly treat central nervous system (CNS) disorders by modifying the patient’s microbiome.
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This builds on an array of preclinical research that has shown a link between gut bacteria and neurological conditions such as autism spectrum disorders (ASD) and Parkinson’s Disease.
The field has received a lot of buzz in recent years, but a major leap is still needed to move from mouse models to patients with diseases.
In an email response to questions, cofounder and CEO of Axial Biotherapeutics David Donabedian said the scientific theories are now well-established.
“Growing evidence suggest that the composition of the microbiota, specifically in the gut, plays an important role in human health and disease and that misregulations can contribute to a variety of diseases,” Donabedian said, adding that additional studies are needed “to further elucidate the distinct roles of gut microbiota in relation to different CNS disorders.”
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Axial’s technology platform was licensed from the Mazmanian Lab at Caltech in Pasadena, California. Led by Professor Sarkis Mazmanian, the lab was one of the first to show that autism spectrum disorders (ASD) could be altered in mouse models by modifying the microbiome.
Mazmanian helped found Axial and will serve as a company director. His research has been far broader than ASD, which is reflected in the companies development aims.
“We will build a unique microbiome discovery platform targeting the gut-brain axis and generate a diverse pipeline of new therapies and potential biomarkers for vastly underserved neurological diseases and disorders,” Donabedian said. “Our product candidates could be quite diverse depending on the indication and regulatory strategy that we choose to pursue.”
Until now, the low-hanging fruit in the field has been gastrointestinal infections and disorders, and to a lesser extent, metabolic and immune disorders. The benefit here is that the bacteria is at the scene of the crime — in the gut or directly interacting with the blood and immune systems.
San Francisco-based Second Genome targets inflammatory bowel disease (IBD) and metabolic disease. In Boston, Seres Therapeutics has a Phase 2 candidate for recurrent Clostridium difficile infections, as well as earlier clinical and preclinical programs for IBD, metabolic diseases, and drug-resistant bacterial infections.
Another Boston company, Synlogic, has clinical programs for two rare diseases, urea cycle disorder (UCD) and phenylketonuria (PKU), which are mediated through the liver.
At least one other company is targeting the gut-brain axis. Kallyope launched in Dec. 2015, with a $44 million Series A. Founded and headquartered in New York City, the company has not announced any clinical trials. Like Axial, it is developing a drug development platform that could be applied to many CNS disorders.
When asked about the competition, Donabedian acknowledged that the field was hot, but said he believes Axial has an edge.
“A growing understanding of how imbalances in the microbiome contribute to disease is leading to a boom in funding and new company creation and we’ve seen one or two other companies focused on the gut-brain axis,” Donabedian said. “We believe Axial Biotherapeutics has a leading position in the CNS-microbiome space.”
Alongside Domain Associates and Longwood Fund, Axial’s Series A included financing from Kairos Ventures, Heritage Medical Systems, and “a group of high net worth individuals based in Southern California.”
Donabedian said the organization is currently virtual, working with consultants in both Southern California and Boston.
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