Avaxia initiates AVX-470 Phase 1b clinical study in ulcerative colitis

Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, announced today that the first patient has been dosed in a Phase 1b clinical study of AVX-470, an oral anti-TNF antibody, for the treatment of ulcerative colitis. Ulcerative colitis is a serious disease characterized by chronic inflammation in the colon. This chronic inflammation causes numerous debilitating effects for patients and often results in colon removal for patients with uncontrolled disease.

This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of AVX-470 in ulcerative colitis patients. Avaxia plans to enroll 24 patients in three dose groups, with six patients receiving the study drug and two patients receiving placebo in each dose group for a period of 28 days. The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers. Avaxia is enrolling patients in the U.S., Canada and Europe and expects to have top-line results by the end of this year.

"Avaxia is thrilled to take this first step in the clinical development of AVX-470. Patients need better treatments for inflammatory bowel disease (IBD), including ulcerative colitis," said Barbara S. Fox, CEO of Avaxia. "Although currently marketed injectable anti-TNF therapeutics are effective in IBD, they also come with potentially dangerous side effects due to generalized immunosuppression. We hope that AVX-470 will provide patients with an important new treatment option. As a gut-targeted therapeutic, AVX-470 is an oral anti-TNF antibody that is designed to stay in the gut, suppressing inflammation only where the disease occurs. We believe that this approach has the potential to reduce or eliminate the side effects associated with other anti-TNF therapeutics while retaining their efficacy in IBD."