Japanese pharmaceutical firm Takeda, and Germany-based Zedira and Dr. Falk Pharma GmbH have announced a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational therapy for the treatment of celiac disease.

TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage to the small intestine. There are currently no approved therapies for the treatment of celiac disease.

Under the terms of the agreement, Takeda and Dr. Falk Pharma will conduct global clinical studies for TAK-227 in celiac disease. Takeda will receive an exclusive license to develop and commercialise TAK-227 in the United States and other territories outside of Europe, Canada, Australia and China.

Zedira and Dr. Falk Pharma will receive an upfront payment and are eligible to receive potential development, regulatory and commercial milestones, as well as royalties on net sales. Originally discovered by Zedira, Dr. Falk Pharma licensed the European rights to ZED1227 from Zedira in 2011 and assumed responsibility for preclinical and clinical development of the programme.

Takeda is advancing a portfolio of investigational therapies for the potential treatment of celiac disease. In addition to TAK-227, Takeda is developing two other investigational celiac disease therapies that recently entered Phase 2 clinical trials.