Takeda, Zedira and Dr Falk Pharma Agree to Develop Celiac Disease Drug Therapy

Celiac.com 12/19/2022 - Major drug firms Takeda, Zedira, and Dr. Falk Pharma GmbH, have announced a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational drug for the treatment of celiac disease. 

According to the Takeda press release, TAK-227 is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the gut.

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TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease. It works by "targeting the dysregulated transglutaminase to prevent mucosal damage in the small intestine by preventing the body’s immune response to gluten, a disease process mediated by activation of gluten-specific T cells," according to Takeda

A Phase 2a proof-of-concept study published in the New England Journal of Medicine showed that, in addition to being safe and well tolerated during a six-week gluten challenge, TAK-227 conveyed a protective effect on the duodenal mucosa, and celiac-related symptoms. 

“Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life,” said Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma

The collaboration agreement gives Takeda exclusive license to develop and commercialize ZED1227/TAK-227 in the United States and countries outside of Europe, Canada, Australia and China, and adds a third investigational drug to Takeda’s development pipeline for celiac disease treatment.

Obviously, any drug that can help to prevent mucosal damage in the gut when people consume gluten will be interesting and potentially helpful to a great many people with celiac disease.  We'll need to keep an eye on the details, especially any side-effects, and the degree of protection, etc. to know for sure. Still, the deal is important because it reiterates the companies' commitment to this celiac disease drug, and to continue doing the heavy lifting in developing other drugs to treat celiac disease.

Stay tuned for more on this and related stories.

Read more in the Takeda Press Release