Avaxia Biologics gets nod from FDA for investigation of new drug

Avaxia Biologics Inc announced yesterday (November 27th) that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for AVX-470.

The privately held biotechnology company develops oral antibody drugs that act locally within the digestive tract and this approval from the FDA will enable it to utilise AVX-470 in trials for the treatment of ulcerative colitis.

AVX-470 is an anti-TNF (tumour necrosis factor) polyclonal antibody and is the first clinical contender to come from the firm's oral antibody platform.

TNF is a pro-inflammatory protein that has been involved in inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.

A phase 1b clinical trial of AVX-470 in patients with active ulcerative colitis will be scheduled by the company in the near future.

"Clearance of the IND allows us to advance AVX-470 into clinical development, which furthers our goal of providing patients afflicted with inflammatory bowel disease with a promising new treatment option," stated Barbara S Fox, chief executive officer of the enterprise.

AVX-470 is delivered straight to the gastrointestinal (GI) tract and because of this, it has less potential for systemic immunosuppression when compared to injectable anti-TNF treatments.

At the same time, it retains the proven advantages of anti-TNF antibody therapy for inflammatory bowel disease, explained Ms Fox.

Presently, injectable anti-TNF antibodies are utilised as a successful therapy for numerous IBD sufferers, generating around £1.5 billion in sales last year.

Suppression of the immune system right through the body, not just locally in the GI tract where the disease lives, is caused by the injections - resulting in potentially dangerous side-effects.

The aim of the research investigation is to have a safer anti-TNF drug for IBD.

AVX-470 is taken orally rather than injected and is intended to stay in the GI tract where the swelling arises, rather than be dispensed throughout the body.

Posted by Ben Evans