A biopharmaceutical company that’s already raised at least $42 million for its celiac disease drug now has $6 million more as it works through a second phase 2 trial.
Alvine Pharmaceuticals’ lead candidate is a mix of two recombinant gluten-specific proteases that’s designed to be used along with a gluten-free diet to prevent immune reactions associated with celiac disease. As disclosed in a recently filed U.S. Securities and Exchange Commission document, the company has raised at least $6 million in debt and other nonequity securities, and could raise up to $500K more. Chief business officer James Watson did not respond to a request for comment.
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Celiac disease is characterized by an immune response elicited by the ingestion of gluten, a storage protein found in wheat, rye and barley. That response affects the process of the small intestine and can inhibit the absorption of nutrients into the body, which can potentially cause a host of deficiency complications and other physical symptoms. It’s typically managed with a gluten-free diet, but in a 200-patient study conducted by Alvine, 90 percent of celiac patients who followed a gluten-free diet still reported symptoms of the disease.
ALV003 is designed to be taken orally by people with celiac disease at the time of a meal. It mixes with and breaks down the gluten in food before it can reach the small intestine, where it would cause inflammatory responses. In a phase 2a study, the drug met its endpoints and demonstrated that it diminished gluten-induced intestinal injury in celiac patients who also followed a gluten-free diet. According to clinicaltrial.gov, it’s currently in a study (likely phase 2b) with a March 2013 completion date.
The U.S. Food and Drug Administration fast-tracked the experimental drug last fall, which means the company can interact more frequently with the FDA during clinical development and could potentially receive a speedier review of a New Drug Application.
The San Carlos, California biopharmaceutical company was founded in 2006 based on technology developed at Stanford University. It’s backed by investors including Abbott Biotech Ventures, Panorama Capital, InterWest Partners, Prospect Venture Partners, Sofinnova Ventures, Black River Asset Management and Flagship Ventures.
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In the market for alternative celiac disease treatments, Alvine appears to be leading the way. Alba Therapeutics is also conducting a phase 2b clinical study of its celiac disease drug, but that drug has delivered disappointing results in previous studies. ImmusanT is conducting phase 1 trials of its vaccine, Nexvax2.
An estimated 3 million Americans have celiac disease — although as many as 85 percent of them may be undiagnosed.