The launches of Alba/Teva’s larazotide acetate and Alvine/AbbVie’s latiglutenase for treating celiac disease could drive sales in the US and five major European markets (5EU: Germany, France, Spain, Italy and the UK) to reach approximately $551.1 million by 2023, according to an analyst with research and consulting firm GlobalData.

With larazotide acetate expected to enter the US and 5EU markets in Q1 2018 and Q1 2019, respectively, followed by latiglutenase in Q1 2019 and Q1 2020, respectively, there will be new therapy choices for the estimated 600,000 diagnosed patients in these countries, whose current standard of care is to follow a strict gluten-free diet (GFD).

Abhilok Garg, Ph.D., GlobalData’s Analyst covering Immunology, states that Key Opinion Leaders (KOLs) interviewed by GlobalData from May to September this year suggested that the two drugs are likely to be prescribed to celiac patients in combination, due to their differing but complementary mechanisms of action.

Furthermore, research presented at the recent United European Gastroenterology Week (UEGW) indicates that “on-demand” enzymatic treatment is the most preferred pharmacological therapy type among celiac patients.

Garg says: “This is positive news for the launch of latiglutenase, an enzymatic treatment that breaks down gluten peptides into non-toxic forms in the small intestine.

“While latiglutenase is currently being developed as a chronic drug treatment, GlobalData’s interviews with KOLs have indicated that clinical experience with this drug could dictate the way it is prescribed to patients, and that it may in some cases be used as an “on demand” treatment.”

The analyst adds that larazotide acetate has been designed to modulate tight junctions (TJs) in the small bowel epithelium, but excitement over the drug’s potential launch has been further fueled by research showing that celiac disease patients have altered intracellular spaces and TJ structures in the lower esophagus.

Garg continues: “These may explain the high prevalence of reflux symptoms in patients, which can be reversed by following a GFD.

“More importantly, this research identifies a pathological mechanism that a TJ modulator, such as larazotide acetate, could target in patients with celiac disease and other associated gastrointestinal disorders characterised by the breakdown of intraepithelial TJs, leading to increased intracellular permeability.”