Clinical-stage biopharmaceutical company Avaxia Biologics has dosed the first patient in a Phase Ib clinical study of its gut-targeted anti-TNF antibody, for the treatment of ulcerative colitis.
AVX-470, which is orally administered, specifically suppresses the gastrointestinal tract's immune response to reduce inflammation in the colon.
The drug has the potential to become a first-line therapy for inflammatory bowel disease (IBD), which also includes Crohn's disease.
The study will enrol 24 patients from the US, Canada and Europe to demonstrate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AVX-47.
Patients will be randomised into 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, according to the company.
The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers.
Avaxia Biologics CEO Barbara Fox said currently marketed injectable anti-TNF therapeutics come with potentially dangerous side effects due to generalised immunosuppression.
"We hope that AVX-470 will provide patients with an important new treatment option," Fox said.
"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."
The company is expecting to present the study results by the end of 2013.
Image: H&E stain of a colonic biopsy showing a crypt abscess, a classic finding in ulcerative colitis. Photo: Courtesy of KGH.