The National Institutes of Health’s (NIH) National Institute of Diabetes and Digestive and Kidney Diseases recently granted Symbiotix Biotherapies $2 million to support research and of development of Polysaccharide A (PSA), the first potentially therapeutic molecule to emerge from the human microbiome and a possible new therapeutic avenue for diseases such as inflammatory bowel disease (IBD).

The Phase II Small Business Technology Transfer award will enable completion of fundamental translational research activities and also support the development/manufacturing process to move PSA into human trials as a new treatment for immune-mediated conditions such as IBD.

PSA is a first-in-class oral therapy that activates regulatory T cells, which exert an anti-inflammatory effect through the production of IL-10, an anti-inflammatory cytokine that plays an essential immunoregulator role in the intestinal tract.

This is the fourth award that Symbiotix has received from NIH for its development programs, now totalling more than $5 million in NIH support.

“Many of the existing FDA-approved drugs for IBD are ineffective in large subsets of patients or have significant side effects,” Sarkis Mazmanian, PhD, the Louis & Nelly Soux Professor of Microbiology in the Division of Biology & Biological Engineering at the California Institute of Technology, said in a press release. “This award will provide funding to advance PSA as a possible safe and effective new oral therapy for many patients suffering with IBD,” said Mazmanian, co-founder of Symbiotix. The studies funded through this award will be conducted by Symbiotix in collaboration with the California Institute of Technology.

“We are grateful for the continued support by NIH as we move forward the first molecule from the human microbiome with therapeutic potential. Backed by over two decades of rigorous scientific research and robust intellectual property from leading institutions, Symbiotix is pioneering the development of molecular therapeutics from biologically active organisms found in the human microbiome,” said Nader Yaghoubi, M.D., PhD, president and chief executive ffficer of Symbiotix.

Inflammatory bowel disease (IBD) is an idiopathic disease caused by a dysregulated immune response to host intestinal microflora. The two major types of inflammatory bowel disease are ulcerative colitis, which is limited to the colon, and Crohn’s disease, which can affect any segment of the gastrointestinal tract from the mouth to the anus. In the U.S., it is estimated that up to 1.3 million people suffer from IBD.