Celiac disease, a chronic autoimmune disorder triggered by the ingestion of gluten in genetically predisposed individuals, has long had limited treatment options—primarily requiring a strict gluten-free diet. However, ongoing research and development in the celiac disease pipeline are bringing promising new celiac disease drugs into the spotlight. These therapies are being designed to address the root cause of the disease, offering patients more flexibility in managing their condition and potentially improving quality of life.

This article explores six celiac disease therapies currently in mid-stage development, highlighting their mechanisms of action and potential to revolutionize celiac disease treatment.

1. Alvine Pharmaceuticals’ ALV-003

ALV-003 is a promising oral therapy currently in Phase II trials. It aims to degrade gluten in the stomach before it can trigger an immune response in people with celiac disease. By breaking down gluten into smaller peptides, ALV-003 seeks to prevent the activation of the immune system, which is the hallmark of celiac disease. If successful, it could enable patients to consume foods containing gluten without triggering adverse effects.

Celiac Disease Pipeline Status: Mid-stage, Phase II.

2. ImmusanT’s Nexvax2

Nexvax2 is an immunotherapy currently undergoing Phase II clinical trials, designed to treat celiac disease by desensitizing patients to gluten. The therapy works by introducing small amounts of gluten peptides into the body to retrain the immune system to tolerate gluten, potentially reducing the need for a lifelong gluten-free diet. This treatment targets the root cause of celiac disease, offering a more long-term solution.

Celiac Disease Drugs: Immunotherapy-based, Phase II.

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3. Provention Bio’s PRV-015

PRV-015 is an anti-interleukin-15 (IL-15) monoclonal antibody that aims to modulate the immune response in individuals with celiac disease. By inhibiting IL-15, a protein involved in the activation of immune cells that attack the intestinal lining, PRV-015 could reduce the inflammation and damage caused by gluten ingestion. The therapy is currently in Phase II trials and holds promise as a disease-modifying treatment.

Celiac Disease Pipeline: Targeted immune therapy, Phase II.

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4. Bioline RX’s BL-7010

BL-7010 is an oral, non-digestible polymer currently being evaluated in clinical trials for its ability to bind gluten in the gastrointestinal tract and prevent its absorption. By binding gluten, BL-7010 prevents the harmful interaction between gluten and the immune system, reducing the inflammatory response in celiac patients. This drug represents a novel approach to managing celiac disease by offering patients an option for gluten protection rather than avoiding gluten altogether.

Celiac Disease Drugs: Oral polymer therapy, Phase II.

5. Zedira’s ZED1227

ZED1227 is an oral enzyme therapy that aims to treat celiac disease by breaking down gluten in the digestive system before it can interact with the immune system. Currently in Phase II trials, ZED1227 could offer an alternative treatment for patients who are unable or unwilling to strictly follow a gluten-free diet. If successful, it may enable patients to consume gluten-containing foods without the associated immune reactions.

Celiac Disease Treatment: Enzyme-based therapy, Phase II.

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6. Theravance Biopharma’s TD-1473

TD-1473 is an oral small molecule that targets the gut’s immune pathways, specifically the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) pathway, which plays a key role in the inflammatory process in celiac disease. This therapy aims to reduce the inflammation and damage to the small intestine caused by gluten exposure. Currently in Phase II clinical trials, TD-1473 has the potential to provide patients with a more effective treatment option than current anti-inflammatory drugs.

Celiac Disease Pipeline: Small molecule inhibitor, Phase II.

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Conclusion

These six celiac disease therapies in mid-stage development represent a significant leap forward in the quest for more effective and convenient treatments for the disorder. By targeting different mechanisms—whether breaking down gluten, modifying the immune response, or reducing inflammation—these celiac disease drugs offer the potential for a broader range of treatment options. As these therapies advance through clinical trials, they could reshape the celiac disease treatment landscape, providing patients with new tools to manage their condition and possibly improving their quality of life.

With increasing investment and research into the celiac disease pipeline, these therapies offer a hopeful outlook for those affected by celiac disease, moving beyond the restrictive gluten-free diet to more accessible and personalized treatment strategies.

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