Celiac disease sufferers unfortunately can't give up the gluten-free food just yet, but there is a chance of at least some relief in the future: AbbVie is collaborating with celiac disease therapeutics developer Alvine Pharmaceuticals to develop a novel oral treatment for patients with celiac disease, currently in Phase II development.
The treatment in question, ALV003, is an investigational oral therapy composed of two recombinant, gluten-specific enzymes—a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP)—that degrade gluten in vitro and in human clinical testing, and may reduce the symptoms and intestinal injury associated with celiac disease in patients attempting to adhere to a gluten-free diet. Data from a Phase IIa study reported at Digestive Disease Week 2012, showed reduction of intestinal inflammation in patients exposed to gluten and treated with ALV003 compared to patients treated with placebo. ALV003 received Fast Track designation from the U.S. FDA for the potential treatment of patients with celiac disease back in September.
Under the deal, AbbVie will make an initial up-front payment of $70 million for an exclusive option to either acquire the assets relating to ALV003, or the equity of the company. Alvine will maintain responsibility for Phase II clinical development, and upon successful completion of the approximately 500 patient Phase IIb study, AbbVie may exercise its option for the agreed upon additional consideration. Alvine will also be entitled to receive a milestone payment upon AbbVie's initiation of Phase III development.
"Celiac disease is an area with significant unmet medical need," said Scott Brun, M.D., vp, pharmaceutical development, AbbVie. "Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment. AbbVie has significant experience within immunology and gastroenterology and the exclusive option to acquire this asset complements AbbVie's broad mid-stage pipeline."
AbbVie was an early investor in Alvine Pharmaceuticals, in collaboration with AbbVie Biotech Ventures, a subsidiary of AbbVie dedicated to making early investments in emerging biotech and pharmaceutical companies.