May marks Coeliac Disease Awareness Month in the US. Coeliac disease is an autoimmune disorder initiated in the small intestine where the patient’s immune system causes damage to the villi after the intake of gluten. The disease represents an area of high unmet clinical need, because no products have been approved specifically for this indication.

Patients have historically needed to maintain a strict gluten-free diet in addition to using corticosteroids and immunosuppressants. But GlobalData expects the disease landscape to evolve significantly in the coming years. The approval of 9 Metres Biopharma’s larazotide acetate, expected within the next several years, will mark the first coeliac disease-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. Figure 1 summarises all the pipeline products in Phase I, II and III development for coeliac disease.

At the moment, the only medically accepted way to manage coeliac disease is a strict gluten-free diet. But this diet is challenging to maintain, either due to cost or the unexpected presence of gluten in products such as cosmetics.  Although a low-gluten or gluten-free diet will still be required even after these treatments are administered, 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 Metre Biopharma’s larazotide acetate, an oral zonulin receptor antagonist, is one of the key drugs expected to make a change in the coeliac disease 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 other products are approved. Larazotide’s mechanism of action could also prove effective against other autoimmune conditions and is also being investigated as a treatment for coronavirus disease 2019 (Covid-19).

Another important contestant for the coeliac disease 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 who do not respond to larazotide acetate. Latiglutenase specifically tackles the disease by degrading gluten, which could prove advantageous for larazotide in securing an exclusive market share of patients suffering from more than one autoimmune disorder.

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ImmunogenX has also developed the minimally invasive CypCel diagnostic technology, which aims to provide both the therapeutic and diagnostic tools to treat and monitor coeliac disease patients. GlobalData expects that latiglutenase will have a strong market uptake. The drug’s patent is set to expire in 2028, which poses a significant threat to the brand unless a strategy such as patent extension can be 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 coeliac disease pipeline.

Coeliac disease is a space with promising potential, a fact underlined by the absence of a treatment on the market as well as 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 coeliac disease field, as patients will still have to have little to no gluten in their diet. A multidisciplinary approach, with patient education and awareness, is currently the most useful tool in managing the disease and it will still be expected even after these drugs are approved.