SAN CARLOS, Calif.--()--Alvine Pharmaceuticals, Inc., a leader in celiac disease therapeutics development, announced today that its lead candidate, ALV003, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with celiac disease. Alvine is currently conducting phase 2 clinical trials with ALV003.
“Building on the data from our earlier phase 2A trial that demonstrated the ability of ALV003 to diminish gluten-induced intestinal injury in well-controlled celiac disease patients, we look forward to pursuing phase 2 and phase 3 trials under the Fast Track program.”
“We are very pleased that the FDA has granted ALV003 this Fast Track designation. The decision reflects the seriousness of celiac disease and the potential of ALV003 to address the unmet medical needs of celiac disease patients. Currently there are no approved therapeutic treatment options available to patients and their physicians,” said Abhay Joshi, Ph.D., Alvine’s President and Chief Executive Officer. “Building on the data from our earlier phase 2A trial that demonstrated the ability of ALV003 to diminish gluten-induced intestinal injury in well-controlled celiac disease patients, we look forward to pursuing phase 2 and phase 3 trials under the Fast Track program.”
Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA during clinical development and for the possibility of priority review, which can reduce the time required for FDA review of a New Drug Application.
ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2 clinical development.
About Celiac Disease
Celiac disease is the most common autoimmune disease, affecting approximately 6 million people in the U.S. and E.U. Celiac disease is an acquired autoimmune disorder that develops in genetically susceptible individuals after exposure to dietary gluten, the protein found in wheat, rye and barley that humans cannot fully digest. Celiac disease is a systemic illness that can affect many organ systems, causing chronic gastrointestinal symptoms, such as nausea, diarrhea, and constipation, and can potentially cause serious medical consequences, including malabsorption, osteoporosis, anemia, infections and malignancies. Currently there is no approved therapy for celiac disease and the only option for patients is to attempt to follow a strict, life-long gluten-free diet.
Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, Calif., focused on the development of biologics targeting autoimmune and inflammatory diseases, including celiac disease. Alvine is focusing clinical development efforts on ALV003, an investigational drug in phase 2 trials that could potentially be the first approved therapeutic treatment for patients with celiac disease. For additional information about the company, please visit http://www.alvinepharma.com.