Alvine Pharmaceuticals Announces Positive Results from Phase 1 Clinical Trial of ALV003, Therapy in Development for Celiac Disease
SAN CARLOS, Calif., October 29, 2008 – Alvine Pharmaceuticals, Inc. today announced that it has proven its concept in a Phase 1 clinical trial of ALV003, an oral therapy in development focused on the combination of two proteases designed to detoxify gluten, and intended for patients with celiac disease. The results of this trial confirm that single doses of up to 1,800 mg of ALV003 have been shown to be safe and well tolerated by healthy volunteers. Doses of 300 mg were able, after 30 minutes in the stomach, to reduce up to 96% of the gluten contained in a meal and were well tolerated by celiacs. Additionally, doses as low as 100 mg demonstrated biological activity capable of breaking down gluten in the stomach.
“The results of the Phase 1 clinical trial of ALV003 represent a major step towards achieving a better quality of life for celiacs as there are currently no approved pharmaceutical therapies,” said Dr. Ciarán P. Kelly, medical director of the Celiac Center at Beth Israel Deaconess Medical Center and Harvard Medical School . “The gluten-free diet is difficult to follow and the potential health consequences of gluten exposure are serious, so there is a huge need for a drug like ALV003 or any other new therapy for celiac disease.”
The Alvine company also presented in October 2008, at the UEGW International Conference (United European Gastroenterology Week ) in Vienna, Austria, data from an Australian study of celiac patients. This study demonstrated that celiacs who ingested gluten previously treated with ALV003 showed an elimination of gluten-specific peripheral reactive T cells as measured by the ELISpot cellular response detection test. The study, carried out at Alfred Hospital and the Burnet Institute in Melbourne, Australia, suggests that the gluten-specific ELISpot response may be a useful test to assess the effectiveness of therapies in celiacs.
“The results of these studies support the use of ALV003 as a medication that can accompany a meal in order to counter unintentional exposure to gluten. In addition, the ELISpot study provides evidence that treatment of gluten with ALV003 may result in reduced immune response to gluten in patients with celiac disease,” reports Dr. Peter HR Green, Professor of Clinic of Medicine and director of the Center for Celiac Disease at Columbia University. “These results provide us with a strong reason to promote the clinical development of this drug as a treatment for celiac disease. ”
About the ALV003:
ALV003 is an orally administered combination of two proteases designed to break down gluten into non-toxic 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).
Alvine Pharmaceuticals, Inc., is a privately held biopharmaceutical company dedicated to the development and commercialization of therapies for gastrointestinal and autoimmune diseases. Alvine’s lead product candidate is ALV003, a combination of proteases designed to digest gluten. It is currently in development to treat patients with CD.