No one knows better than people with celiac disease how hard it is to stay on a completely gluten-free diet. Gluten is found naturally in many favorite foods, as well as being added in somewhat unexpected places, like soy sauce.
Any medication that could help treat celiac disease would be extremely welcome. Until fairly recently, there were no drugs in development for this condition. However, the knowledge that 1% of the population may have celiac disease has convinced pharmaceutical companies that it is worth their time and money to try and develop treatments for CD. There are a number of medications in various stages of development. Industry experts have estimated that there may be as much as 650 million dollars a year spent on drugs to treat celiac disease by the year 2019. That kind of potential market is a significant incentive for drug companies to develop treatments for CD.
ALV0003 is such a drug, in what is called phase 2 development in the United States. It is being tested on people with celiac disease for effectiveness and safety. Because there is no drug treatment available for CD, the FDA has put this drug on their “fast track,” allowing testing to be done as quickly as possible.
ALV0003 is made up of two enzymes that can digest the parts of gluten (gliadins) that cause damage in people with celiac disease. In theory, such a drug could be taken and break down gluten in the diet before it has a chance to get into the intestinal cells. Practically speaking, there may never be a drug that digests all of the gluten and can replace a gluten-free diet. However, a medication like ALV0003 might digest enough gluten to remove concerns about gluten contamination when a person with celiac disease is eating away from home, or allow a person to eat something that has small amounts of gluten in it.
ALV0003 is being developed by two companies working together, AbbVie and Alvine Pharmaceuticals. This partnership will involve testing the drug in both the USA and Europe, because some 6 million people in the United States and Europe are thought to have celiac disease. AbbVie is a global company, while Alvine is based in California. Both have expertise they can use to help test this drug. AbbieVie has done a lot of work in new treatments for gastrointestinal diseases.
In earlier studies, ALV0003 broke down gluten in a laboratory setting. A six-week, phase 2a study giving the drug to patients with CD was completed, and its findings were reported at Digestive Disease Week in 2012. Patients with celiac disease who took the drug showed less evidence of intestinal inflammation while eating gluten than those who did not take the drug. This was determined by intestinal biopsy.
In addition, researchers have developed what they call a “patient-reported outcome tool” to evaluate success or failure of the drug. This would be used in addition to intestinal biopsies in future research, and involves patients’ reports of their symptoms
The next step, Phase 2b will be a larger study involving 500 people. This is expected to be completed in 2014 or 2015.
Alvine itself has other potential treatments for celiac disease that are in very early stages of investigation. At the current time, there are other drugs in active development besides ALV0003. One drug makes it harder for parts of gluten to get into intestinal cells. Another is a vaccine (Nexvax2, made by Immusan T) that may help the majority of people with CD who have a specific genetic HLA type, HLA-DQ2.
The fact that money is being spent on research for celiac disease treatments and that there has been a successful phase 2a trial for ALV0003 should be encouraging to people with CD. It may not be so very far away that there are other things beyond the gluten-free diet to help people manage their disease.