Avaxia Biologics has treated the first patient in a Phase1b clinical study using AVX drug dosage, designed for the treatment of ulcerative colitis.
The gut-targeted anti-TNF antibody drug is injected into the body to suppress the immune system and reduce inflammation in the colon.
The study, which will enroll 24 patients from the US, Canada and Europe, will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of AVX-470 in ulcerative colitis patients.
The company said it will randomize patients in three dose groups, with six patients to receive the study drug and two patients to receive placebo in each dose group for a period of 28 days.
The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers. Avaxia Biologics CEO Barbara Fox said currently marketed injectable anti-TNF therapeutics comes with potentially dangerous side effects due to generalized immunosuppression.
“We hope that AVX-470 will provide patients with an important new treatment option,” Fox added.
“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.