Celiac disease (CD) represents an area of high unmet clinical need as there are no products that have been approved specifically for this indication. Historically, patients have needed to maintain a strict gluten-free diet (GFD) in addition to using corticosteroids and immunosuppressants. However, the disease landscape is set to evolve significantly in the coming years. Notably, the approval of 9 Meters Biopharma’s larazotide acetate, expected within the next several years, will mark the first CD-specific agent to enter the market. There are 12 more drugs currently in the pipeline, four of which could gain approval within the next ten years, says GlobalData, a leading data and analytics company.

Chris Pilis, Immunology Analyst at GlobalData, comments: “Currently, the only medically accepted way to manage CD is a strict GFD. However, GFD is challenging to maintain, either due to cost or unexpected presence of gluten in products such as cosmetics. Although a low- or no-gluten diet will still be required even after administration of these treatments, the late-stage pipeline products represent exciting new options for patients that will be able to better manage symptoms and risks, including infertility, bone disorders, and malignancies.”

9 Meter Biopharma’s larazotide acetate, an oral zonulin receptor antagonist, is one of the key CD drugs expected to make a change in the CD space. Larazotide acetate tightens the junctions between small intestinal cells, effectively prohibiting gluten from passing into the blood circulation and thereby causing an autoimmune response. Having the first-to-market advantage, larazotide could establish a good reputation among physicians and patients and therefore gain an important and stable market share, even after approval of other CD products. Moreover, larazotide’s mechanism of action could prove effective against other autoimmune conditions and is also being investigated as a treatment for COVID-19.

Pilis continues: “Another important contestant for the CD market is ImmunogenX’s latiglutenase, a combination of orally administered gluten proteases. Although latiglutenase is expected to be the second product to market, its different mechanism of action could still prove useful for patients not responding to larazotide acetate.”

Latiglutenase specifically tackles CD by degrading gluten, which could prove advantageous for larazotide in securing an exclusive market share of patients suffering from more than one autoimmune disorder. However, ImmunogenX has also developed the minimally invasive CypCel diagnostic technology, aiming to provide both the therapeutic and the diagnostic tools to treat and monitor CD patients. GlobalData expects that latiglutenase will have a strong market uptake in CD. Notably, latiglutenase’s patent is set to expire in 2028, a significant threat to the brand unless a strategy such as patent extension is pursued in the coming years.

There are several drugs currently in Phase I and II of development, yet they will require several more years of clinical trials before gaining approval. It is noteworthy that there were no signs that the COVID-19 pandemic slowed down the CD pipeline.

Pilis concludes: “CD is a space with promising potential, a fact underlined by the absence of a treatment on the market as well as by the attraction of Big Pharma companies such as Pfizer and Takeda. Larazotide acetate and latiglutenase are candidates setting high expectations, but they will only partially fulfil the unmet needs of the CD field as patients will still have to maintain no to low gluten levels in their diet. A multidisciplinary approach with patient education and awareness is currently the most useful tool in managing CD and it will still be expected even after approval of these drugs.”