New research and development news for ulcerative colitis (UC) indicates that a promising, new front-line therapy for the disease that can be taken in pill form may be making its way toward becoming a viable option.
AvaxiaBiologics Inc. recently stated in a press release that they will announce the results from a Phase 1b clinical trial to assess AVX-470 to treat active ulcerative colitis at the United European Gastroenterology Week in Vienna Austria, and at the Annual Scientific Meeting of the American College of Gastroenterology in Philadelphia.
AVX-470 is the first gut-targeted anti-TNF antibody being developed as a therapeutic for ulcerative colitis clinical applications. Other anti-TNF drugs are available to treat intestinal bowel disease. However, these have to be injected and can have serious side effects, though rare, such as increasing the risk for infections. Such drawbacks pushed these therapeutics to second and third-line therapeutics, but earlier use would benefit patients. AVX-470 represents a potentially significant improvement, since is orally administered and specifically targets the gut. The company is expecting AVX-470 to be approved as a first-line treatment to IBD.
Barbara S. Fox Ph.D., Chief Executive Officer for the company, commented, “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. 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.”
The results will be presented as two communications entitled “AVX-470 an Orally Delivered Anti-TNF Antibody for Treatment of Acute Ulcerative Colitis: Results of a First-in-Human Trial” and “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”, presented by M. Scott Harris M.D. Chief Medical Officer in Austria and Barbara S. Fox Ph.D. Chief Executive Officer and Deborah S. Hartman Ph.D. Vice President of Research in Philadelphia.
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