Mucositis

Mucositis is an inflammation and ulceration of the mouth and gastrointestinal tract caused by cancer chemotherapy and radiation therapy. It is the major debilitating side effect of many cancer treatment regimens and frequently limits the dose or duration of cancer treatment that can be administered to the afflicted patient. The few treatments available for mucositis are of modest efficacy and are only approved for a limited number of indications. Avaxia is developing Guardian Antibodies™ for mucositis. These antibodies will be applied topically prior to and during cancer treatment to reduce the development of this painful condition.

Inflammatory bowel disease

Inflammatory bowel disease (IBD) is a debilitating autoimmune disease associated with significant inflammation in the intestinal tract. Systemically delivered anti-TNF antibodies have been approved for the treatment of both types of IBD, Crohn’s disease and Ulcerative Colitis. Although highly effective, these antibodies are associated with significant safety issues, including the reactivation of tuberculosis and an increased risk of malignancy. Avaxia is developing Guardian Antibodies™ to neutralize inflammatory cytokines in the small intestine. Polyclonal anti-cytokine antibodies are expected to be more effective than the monoclonal antibodies currently in use. Furthermore, local delivery to the site of inflammation is expected to result in fewer side effects than are seen with injected monoclonal antibodies.

Celiac disease

Celiac disease is an autoimmune disease caused by an inappropriate response to gluten in ingested grains. The disease has a variety of clinical manifestations, including diarrhea, abdominal pain, osteoporosis, anemia, and an increased risk of diabetes and malignancies. The overall prevalence of celiac disease in the U.S. and Europe is approximately 1:133. There are no products on the market for celiac disease; the only available treatment for celiac disease is a strict gluten-free diet.

Avaxia is developing orally administered anti-gluten antibodies for celiac disease. The antibodies will neutralize low levels of gluten in the small intestine and are designed for use in association with a gluten-free diet. The product will primarily be taken with meals when low levels of gluten cannot be avoided (travel, social and business functions). Patients who cannot control their disease with a gluten-free diet may be dosed chronically.

Obesity / diabetes

The small intestine expresses multiple receptors and transporters for simple sugars. These receptors both sense the nutrient content of an ingested meal and mediate the direct transport of the sugars. Avaxia is developing Guardian Antibodies™ to modulate sugar transporters and receptors in the small intestine. The goal of this program is to modulate the post-prandial rise in glucose without inhibiting incretin release. Such antibodies would be expected to be effective in the treatment of obesity and type II diabetes.