Alvine targets Phase IIb celiac disease trial this year

Alvine Pharmaceuticals Inc. is inching closer to a treatment for debilitating celiac disease.

The privately held San Carlos companyreported data Tuesday from a Phase IIa trial of its drug, called ALV-003, that it believes makes it the first mid-stage celiac disease study to meet predetermined goals. It plans to start a Phase IIb trial later this year.

One-on-One with Dan Adelman, chief medical officer of celiac disease drug developer Alvine Pharmaceuticals

A gluten-free diet is great for celiac disease patients, but even the strictest adherents to dietary restrictions can experience flare ups or chronic symptoms.
That’s where Alvine Pharmaceuticals Inc. comes in with a drug that could make a huge impact. The San Carlos company earlier this month reported results of a Phase IIa trial that showed that its drug, ALV-003, could make a difference in helping patients with gluten-limiting celiac disease. It is the first mid-stage study to get positive results in modulating the immune system’s response to the storage protein.
The 15-employee company is backed by Sofinnova Ventures, InterWest Partners, Prospect Venture Partners, Flagship Ventures, Black River Asset Management and Panorama Capital.

After strong results in one trial, Alvine readies another Phase II in celiac disease

A small trial by Alvine Pharmaceuticals Inc. indicated that its experimental celiac disease drug may reduce the effect of the intestinal disease, the company said Tuesday.
The 41-patient Phase IIa trial by San Carlos-based Alvine found that certain celiac disease patients taking ALV-003 over six weeks had less severe gluten-induced injury to the lining of their intestine.
Alvine Chief Medical Officer Daniel Adelman said in a press release that the company hopes to start a Phase IIb trial next year.