Avaxia Biologics, a biotechnology company developing oral antibodies for diseases of the GI tract, has announced that it has been awarded a Phase I Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, to support the development of a novel antibody therapeutic for inflammatory bowel disease (IBD). This Phase I award provides Avaxia with $213,000 in research and development funds. If early results are promising, the company could receive an additional $750,000 in Phase II funding.

Avaxia is developing a proprietary anti-TNF antibody to be administered orally to patients suffering from IBD. IBD is a chronic inflammatory disorder of the gastrointestinal tract. There are two types of inflammatory bowel disease: Crohn’s disease, primarily affecting the small intestine, and ulcerative colitis, affecting only the colon.

Approximately one million people in the US suffer from IBD. Currently marketed parenteral anti-TNF antibodies are highly effective in treating both Crohn’s disease and ulcerative colitis; however, because they are delivered by injection they neutralize TNF throughout the body and their use is associated with serious side effects, including the reactivation of tuberculosis and a long-term risk of malignancy. Avaxia’s approach will develop an anti-TNF antibody that has a lower risk of systemic immunosuppression and can be used as a first-line therapy for inflammatory bowel disease. The grant Avaxia just received will fund key pre-clinical studies of the antibody in a well-established animal model of IBD.

“We are delighted to have been awarded this grant from the NIH,” said Barbara S Fox, PhD, Avaxia’s founder and CEO. “Our preliminary in vivo animal data indicates that AVX-470, our orally active anti-TNF antibody, protects the intestinal lining from the damaging effects of radiation. This support from the NIH now provides the funding we need to advance the development of this antibody into pre-clinical models of IBD.”

Avaxia is carrying out the grant-funded research in collaboration with Biomodels, a Watertown-based pre-clinical drug research organization. Biomodels specializes in animal models of gastrointestinal diseases, such as IBD. “We are looking forward to working closely with Avaxia Biologics’ scientists in developing and testing a drug that could lead to an orally effective therapy for IBD,” said Edward Fey, managing partner of Biomodels.