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Press Release

Avaxia Biologics To Present AVX-470 Phase 1b Clinical Results at Upcoming Medical Conferences

Avaxia Biologics,Inc.
Posted on: 17 Oct 14

Avaxia Biologics Inc. a clinical-stage biopharmaceutical company developing gut-targeted antibody therapeutics for gastrointestinal diseases announced today that next week it will present results from its successful Phase 1b clinical trial of AVX-470 in active ulcerative colitis at two medical conferences. AVX-470 is a gut-targeted anti-TNF antibody.

A presentation entitled “AVX-470 an Orally Delivered Anti-TNF Antibody for Treatment of Acute Ulcerative Colitis: Results of a First-in-Human Trial” will be given by M. Scott Harris M.D. Chief Medical Officer on Tuesday October 21 from 2:24 p.m. to 2:36 p.m. at United European Gastroenterology Week in Vienna Austria.

A poster entitled “Pharmacokinetics Pharmacodynamics Immunogenicity and Safety of AVX-470 an Oral Bovine-Derived Anti-TNF Antibody in Patients with Active Ulcerative Colitis (UC): Initial Human Experience” poster number P1058 will be presented by Barbara S. Fox Ph.D. Chief Executive Officer and Deborah S. Hartman Ph.D. Vice President of Research on Monday October 20 from 10:30 a.m. to 4:00 p.m. at the Annual Scientific Meeting of the American College of Gastroenterology in Philadelphia.

“We are thrilled to report positive results from our first-in-human Phase 1b clinical trial of AVX-470 in patients with active ulcerative colitis” said Dr. Fox. “Not only did the trial meet its primary and secondary endpoints but we observed consistent efficacy signals across multiple clinical and biomarker datasets that were exploratory endpoints in this trial. These results fully support moving the program into Phase 2 clinical development.”

About AVX-470

AVX-470 is the first gut-targeted anti-TNF antibody in clinical development. The lead indication is inflammatory bowel disease (IBD) a serious disease involving chronic inflammation of the intestinal tract. Currently marketed anti-TNF drugs are highly effective for the treatment of IBD. However despite their success these drugs have two significant drawbacks. One is that they must be infused or injected whereas patients prefer oral medications. More importantly they cause rare but serious side effects such as risk of serious infection because they dampen the immune system throughout the body not just in the intestines where the disease occurs. As a result these drugs are used mostly as a second- or third-line therapy despite evidence that earlier use may improve patient outcomes. In contrast AVX-470 is an orally administered antibody therapeutic that targets the gut potentially improving safety and efficacy over existing anti-TNF therapies. Avaxia believes that AVX-470 has the potential to become a first-line therapy that transforms the treatment of IBD.

About Avaxia Biologics

Avaxia leads the field of gut-targeted antibody therapeutics — orally administered minimally absorbed antibody drugs that are designed to act locally in the gastrointestinal tract. Avaxia’s clinical candidate AVX-470 is an oral anti-TNF antibody for inflammatory bowel disease (IBD). This transformative product offers potentially improved safety and efficacy over existing anti-TNF therapies by focusing immune suppression only where needed in the diseased gut. Avaxia is focused primarily on gastrointestinal diseases such as IBD celiac disease and necrotizing enterocolitis though our proprietary gut-targeted antibody platform can address any disease that has a biological target accessible via the gastrointestinal tract.

Business Wire

Last updated on: 17/10/2014

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