Celiac Disease Drug Therapy: Alvine Pharmaceuticals

As I wrote yesterday, this is the second part of the drug therapies that are currently under development for CD. The first therapy, Larazotide acetate, being developed by Alba Therapeutics is a pill that is being studying to reduce the "leaky gut" condition of CD. Any ingested Gluten will not be allowed to permeate in the intestines and thus the auto-immune reaction will be suppressed. That pill and the one I am writing about today are to be taken in conjunction with a Gluten Free diet and NOT meant to replace being GF.

Alvine Pharmaceuticals is based in San Carlos, California and is currently in Phase I trial of a drug called ALV003. The drug is meant to be taken with your meals (like lactose intolerant medications) to degrade the gluten to a point where the auto-immune response would be non-existant. This would be extremely helpful for those of us who get accidentially "Glutened" while eating out. Read more about their press release announced 10-29-08 below...

Alvine Pharmaceuticals Inc., of San Carlos, Calif., reported proof-of-concept in a Phase I trial of ALV003, an oral protease therapy in development to detoxify gluten, for use by patients with celiac disease. The trial results confirmed that 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 percent reduction of gluten in a meal in the stomach at 30 minutes, and were well tolerated by patients with celiac disease. In addition, doses as low as 100 mg were shown to be biologically active in degrading gluten in the stomach. Based on these results, Alvine plans to initiate Phase 1/2a multidose trials in early 2009.

The trial for this drug began in February 2008 and is currently recruiting participants.

About ALV003
ALV003 is an orally administered combination of two proteases engineered to degrade gluten into non-immunotoxic fragments, by targeting the glutamine and proline residues that are common in gluten. ALV003 consists of a glutamine specific cysteine protease (EP-B2) and a proline specific prolyl endopeptidase (PEP).

Click here for the Alvine Pharmaceuticals Web site.
Contact:
Kirk Essenmacher M.D., M.B.A.
Phone: (650) 596-2434
Vice President of Marketing, Corporate and Strategic Development
or
Revati Shreeniwas M.D.
Phone (650) 596-2433 (Clinical Contact)
Vice President, Clinical Research and Development