Clinical trials of coeliac disease therapy

The latest issue of the Australian Coeliac magazine features an article on an oral protease preparation, ALV003, which is currently being trialled as a coeliac disease therapy.

USA-based Alvine Pharmaceuticals has developed the preparation which consists of a mixture of two protease enzymes. These enzymes are highly targeted to particular regions responsible for gluten toxicity, and result in very effective degradation of toxic gluten fragments in the test tube. It is proposed that such a preparation, when ingested at the same time as a meal containing small amounts of gluten, may potentially degrade the toxic gluten fragments and overcome the problems of unintentional gluten contamination.

A phase-1 clinical trial was conducted in mid 2008, involving 20 coeliac disease volunteers from The Coeliac Society of Victoria. The trial results confirmed single doses of up to 1,800 mg of ALV003 were safe and tolerable in healthy volunteers. Doses at the 300 mg level achieved up to a 96% reduction of gluten in a meal in the stomach at 30 minutes. In addition, doses as low as 100 mg were shown to be biologically active in degrading gluten in the stomach.

While supplements like ALV003 are unlikely to allow a normal gluten containing meal to be consumed, they may reduce or eliminate the harmful effects of meals containing trace amounts of gluten.

These results are encouraging; however, they are early findings in a small number of people, conducted primarily to demonstrate the safety of the product. Larger studies involving participants with coeliac disease, and importantly, assessment of small bowel biopsies are yet to be conducted. Planning for such 'Phase 2' studies of ALV003 are currently underway.

The full article can be accessed on the Coeliac Society website.