Dr. Falk Pharma and Zedira Enter Phase I Clinical Trials for ZED1227

Dr. Falk Pharma and Zedira have announced the start of phase I clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. The small molecule targets the dysregulated transglutaminase within the small intestine in order to dampen the immune response to gluten which drives the disease process.

This approach will offer patients additional safety when applied in support of a ‘mostly’ gluten-free diet thereby improving the quality-of-life of millions of people.

Already in 2011, Dr. Falk Pharma licensed the rights for ZED1227 in Europe and took charge of preclinical and clinical development of the new chemical entity.

The license agreement secured Zedira an upfront payment and further milestone payments as well as royalties. The rights outside Europe are jointly owned by the partners.

The project receives additional support through a grant from the German Ministry for Education and Research within the Cluster of Excellence program “Ci3-Cluster for Individualized Immune Intervention”.

Celiac Disease is the most common chronic inflammation of the small intestine. The autoimmune disease affects about 1% of the population and is caused by alimentary gluten in genetically susceptible individuals.