AbbVie Inc. (ABBV) will pay at least $70 million in a collaboration deal with privately held Alvine Pharmaceuticals to develop an oral treatment for celiac disease.
The investigational drug — ALV003 — contains two enzymes that have been shown to degrade gluten under experimental conditions and in clinical tests on patients. It may reduce the symptoms and intestinal injury associated with celiac disease in patients struggling to comply with a gluten-free diet.
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 can't fully digest, and in some products such as vitamins and lip balms. Celiac disease does damage to the small intestine as the body's immune system reacts to the gluten by attacking the lining of the small intestine. With a damaged intestinal lining in place, the body cannot absorb the nutrients it needs. Eventually, celiac disease can cause anemia, infertility, weak and brittle bones, an itchy skin rash called dermatitis herpetiformis, or other health problems. Symptoms can include: stomach pain, gas, diarrhea, extreme tiredness, change in mood, weight loss, an itchy, blistering skin rash and delayed growth.
People afflicted with celiac disease may not always be aware of their condition as they may not feel sick. Even if they feel sick, they may not have a clue if celiac disease is the underlying cause. The dietary gluten continues to damage the intestines in celiac disease until the diet is modified.
The celiac disease often runs in families. Celiac disease can manifest in both adults and children if you have an affected parent, brother, or sister.
"Celiac disease is an area with significant unmet medical need," Scott Brun, vice president, pharmaceutical development at AbbVie, said in a news release. "Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment."
Under the deal, AbbVie will make an initial upfront payment of $70 million for an exclusive option to either acquire the assets relating to ALV003, or equity in the company. Alvine will be responsible for Phase 2 clinical development, in which the experimental drug ALV003 is given to a larger group of people (100-300) to check if it is effective and to further evaluate its safety.
Once the Phase 2b trials are done successfully, AbbVie may exercise its option for the agreed upon additional consideration. A milestone payment is due for Alvine as AbbVie's initiates the Phase 3 development, in which the drug is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect safety information.
