Founded about a year ago to develop treatments for celiac disease, Alvine Pharmaceuticals Inc. recently raised $21 million in its Series A round to advance its lead product through proof-of-concept studies.

Celiac disease, also known as celiac sprue, is an inherited autoimmune disorder triggered by the consumption of foods containing gluten, a cereal grain protein. Believed to be fairly common - affecting as many as one in 100 people in the U.S. - celiac disease historically has been under-diagnosed with no available drug therapy, said Alvine co-founder Chaitan Khosla, a professor at Stanford University who has "a long-standing interest" in the disease and conducted a research program out of his lab.

"We bandy around the term 'unmet medical need' in this day and age," he said, "but [celiac disease] really does fall into this category. When a doctor diagnoses celiac now, he basically just gives the patient a referral card to a dietician."

The only option for most celiac patients is to eliminate gluten from their diet, but that's not an easy feat given that it's found in so many foods: generally anything containing wheat or flour.

Gluten "is somewhat unusual in the landscape of dietary proteins in that it's much more slowly digested," Khosla said. But, in a celiac patient, "the immune system in the small intestine has been misprimed, so that when it detects gluten it mounts an autoimmune type of response."

He compared the effects of gluten on the intestines to "what diabetes is to the pancreas."

Alvine, which gets its name from a medical term referring to gastrointestinal activity, aims to develop a drug therapy that would allow celiac patients to consume "reasonable quantities" of gluten into their diets, Khosla told BioWorld Today.

The company's lead product, ALV001, a protease, is expected to enter the clinic next year as an oral product, which would be taken with food and designed to break down and detoxify the gluten.

"Basically, it accelerates the digestion of gluten to the point where it's mostly digested, before the gluten arrives in the small intestine," Khosla said.

The recent financing should fund clinical development of ALV001 through proof of concept, and possibly support development of other products. Behind ALV001, Alvine has some "more potent versions of the same kind of product," he said.

For now, Alvine intends to focus exclusively on celiac disease, which Khosla said is "enough of a niche market for us to probably penetrate it in a meaningful way with a small sales force," at least initially. But the company likely would have to consider partnering when celiac disease becomes more frequently diagnosed and addressed.

"If you look at [the celiac space] as an iceberg, where most of it's under the surface and still needing to be diagnosed," he said, "then having a senior partner with a deep reach in the market would help us in the future."

Focused on getting its first product to the clinic, Alvine is planning to build its staff out to 10 or 15 people, with an emphasis on preclinical and clinical development, manufacturing and regulatory expertise.

"We're going to be a very product-focused company in the near term," Khosla said.

Alvine's Series A was led by San Francisco-based Sofinnova Ventures, with support from Palo Alto, Calif.-based Prospect Venture Partners, Menlo Park, Calif.-based InterWest Partners, San Mateo, Calif.-based Cargill Ventures and Cambridge, Mass.-based Flagship Ventures.

The company also named members to its board: Nicola Campbell, of Sofinnova; Ilan Zipkin, of Prospect Venture; Nina Kjellson, of InterWest; and Khosla.

Company co-founders Blair Stewart and Kevin Kaster joined Alvine's management team, assuming the roles of president and vice president of corporate development, respectively.

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