No Longer Gluten-Free: Exploring Potential Biologics Treatments for Celiac Disease

Biologics Development

The growing number of people suffering from celiac disease has prompted the healthcare community to search for answers. Can biologics provide relief to patients struggling with the gluten-free lifestyle?
Image source: Flickr CC user Robert Couse-Baker

Imagine being unable to eat bread without experiencing abdominal discomfort. Or, for that matter, having to avoid any food containing wheat-related by-products for fear of suffering from gastrointestinal issues. That’s the case for over 3 million people in the United States. These people live with celiac disease, an autoimmune disorder that leaves its sufferers unable to digest gluten. Instead, the body’s immune system misidentifies fragments of the gluten protein and attacks the small intestine, damaging it.

Presently, there is no cure for celiac disease. In fact, there is only one approved treatment plan for the condition. Patients must follow a gluten-free diet (GFD), avoiding any intake of the grain protein. But while the treatment plan sounds obvious, it’s not a perfect solution. Biologics companies have begun looking at ways to develop a more lasting, permanent cure.

Biologics Can Bring Relief to Patients with Celiac Disease

On paper, following a strict GFD seems like the best way to manage the illness. After all, if sufferers don’t consume gluten, there’s nothing to trigger the body’s immune system. Unfortunately, the reality of observing a GFD presents a few complications. First of all, it’s a heavy burden to eliminate gluten from dietary intake. Not only does it make shopping for groceries difficult, it limits options should patients want to eat at a restaurant. On top of that, it’s virtually impossible to prevent all intake of gluten. This isn’t necessarily because of nonadherence either, but rather poor labelling on food packages.

To further emphasize the necessity of an alternate treatment plan, the number of people with celiac disease is growing. Are they simply expected to cope with the disorder for the rest of their lives? Without an existing drug treatment, this seems to be the only option.

Biologics, however, can offer another choice. Because there is currently no FDA-approved treatment for celiac disease, companies have an open field in which to develop biotherapeutics. In this instance, the field provides more opportunities than most because of the variety of approaches possible.

For example, a potential biotherapeutic could contain an enzyme that renders gluten harmless by slicing the protein into pieces. Maybe the answer lays with a regulator that prevents gluten from stimulating an immune response.1 Or a company could try methods used to treat other autoimmune diseases and suppress the immune response.2

With so many avenues to pursue though, it can be difficult to determine which method is best. Ultimately, the choice depends on strategy. Is the firm focusing on therapy to be used in conjunction with a GFD to alleviate symptoms? Or are they aiming for a permanent cure? If seeking a biologic with long-term effects, then they might develop a treatment that acts more like an allergy shot and trains the body to tolerate gluten. But if a firm wants something that is more consistent from patient to patient, then a vaccine that acts quickly and tells the body to ignore gluten might be more appropriate.3 The downside of the latter, of course, is that it’s not permanent in the same way a treatment that induces tolerance would be.

With so many targets and approaches available, a wide array of potential treatments is expected. And until the FDA approves a specific therapy, that number is sure to increase. After all, there is no guarantee clinical trials will be successful. If anything, companies need to develop multiple candidates due to the high chances of failure at that particular stage. Even if the FDA approves a treatment for celiac disease, others may still prove necessary. Since the disorder exhibits differently from patient to patient, it’s highly unlikely that one drug will be successful for all. For example, a treatment that targets tight junction modulators might be better suited for patients with highly-damaged small intestines, whereas individuals with relatively undamaged guts might prefer the so-called vaccine method.

No matter which approach is taken in the treatment of celiac disease, any biologics development requires support to aid discovery. Let’s imagine a company is trying to determine which antibodies can suppress the cytokines responsible for the immune response. What are the requirements to make that process more efficient? First, they need easy access to sequence and assay information. Next, they need to analyze and manage the data in such a way that it can offer deeper insight, enabling better decisions and choices in the R&D process. And finally, they could use a way to visualize antibody candidates, allowing them to predict critical traits.

The BIOVIA Biologics Solution is an innovative digital suite that supports the discovery and development of novel biotherapeutics. Not only does it provide tools that can process high volume antibody data, it has the ability to design and manage the screening assays required to ascertain the viability of potential candidates. To further test candidates, the solution also features a 3D modeling environment that allows users to predict and optimize physical properties. Separately, these tools can benefit any biologics R&D laboratory but together, they provide an integrated solution that can give companies the edge they need to compete in a crowded field full of candidates seeking FDA approval. Contact us today to learn more.

  1. “Novel Therapeutic Approaches for Celiac Disease,” May 22, 2014,
  2. “Big News for Celiac Treatment Comes in a Small Package,” February 10, 2011,
  3. “Selecta Takes Nanotech to Gene Therapy, Celiac With New Deals,” May 13, 2015,

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