Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, announced that the United States Patent and Trademark Office has issued four key patents: 7,943,312; 7,928,056; 7,923,532; and 7,910,541, protecting various aspects of Alvine’s core technology. These patents cover gluten degradation with gluten-specific proteases, methods for identifying proteases useful in degrading gluten and reagents for diagnosing celiac disease. Alvine has an exclusive worldwide license to these patents from Stanford University.
The patents provide additional intellectual property protection around ALV003, which is in phase II clinical development in patients with celiac disease. In addition, they also provide protection for: the use of other proteases to degrade gluten into non-immunogenic fragments, methods for identifying such proteases, and methods for degrading gluten ex vivo and in vivo. In the diagnostic area, they provide protection for reagents that may be useful in new diagnostic methods to detect celiac disease.
“The issuance of these patents is a significant achievement for Alvine as they provide further intellectual property protection for the company’s protease development programme,” said Abhay Joshi, PhD, Alvine’s president and CEO. “With our strong patent portfolio and ongoing clinical trials of ALV003, Alvine is building a strong foundation for the successful development of proteases as potential therapeutic agents.”
ALV003 is an orally administered mixture of two recombinant proteases engineered to degrade gluten into non-immunogenic peptide 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). ALV003 is being developed by Alvine as a potential treatment for patients with celiac disease.
Celiac disease is the most common hereditary autoimmune disease with prevalence as high as 1-2% in the US and EU. Intestinal inflammation in celiac disease is triggered by the ingestion of gluten in genetically susceptible individuals. Gluten is a protein found naturally in wheat, rye, and barley, and is one of the most common and nutritionally significant ingredients in the human diet. Patients with celiac disease mount an immune response to gluten and gluten fragments, resulting in systemic immune mediated damage in the gut and other organs. Gluten ingestion can be associated with symptoms such as nausea, diarrhoea, constipation and rash.
Complications of celiac disease can include osteoporosis, anaemia, dermatitis, weight loss, diabetes, autoimmune diseases, intestinal malignancies, peripheral and central nervous system conditions including depression. The only available option for individuals diagnosed with celiac disease today is a life-long adherence to a strict gluten-free diet, which is difficult to follow.
Alvine Pharmaceuticals, Inc. is a privately held biopharmaceutical company dedicated to developing and commercializing therapeutics for autoimmune/gastrointestinal diseases.