02. March 2015

Press Release: Dr. Falk Pharma and Zedira enter phase I clinical trials for a celiac disease drug



Dr. Falk Pharma and Zedira announce 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.

About Zedira:
The Darmstadt-based biotech company has a focus on celiac disease and other transglutaminase-linked conditions in the arena of autoimmunity, fibrotic disease and coagulation. The company develops, produces and markets specialist reagents and kits for research and development as well as for clinical diagnostics. Zedira is also establishing a pipeline of drug candidates adapted to specific indications based on its patented family of low-molecular transglutaminase blockers. ZED1227 is the first direct acting transglutaminase inhibitor entering clinical development. The company is actively progressing follow-on candidate molecules informed by the know-how gained with development of ZED1227 and aims at new approaches in thrombosis prophylaxis. Zedira is a portfolio company of the German High-Tech Gründerfonds.

About Dr. Falk Pharma:
Dr. Falk Pharma specializes in the development and marketing of pharmaceuticals used in hepatology and gastroenterology. Falk is one of the leading European companies in the field marketing its products by means of subsidiaries in selected countries and a network of sales partners. Further, the Falk Foundation, an independent organization associated with Dr. Falk Pharma, is well-known for its international symposia, forums and educational literature supporting medical doctors, patients and their families.

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  • Zedira offers a huge portfolio of reliable specialist transglutaminase related products meant to catalyze research and development, both in academia and industry.

News  

  • Pressemitteilung: Dr. Falk Pharma und Zedira geben den Abschluss der Phase 1b-Studie für ZED1227 zur Zöliakie-Therapie bekannt und planen Start der Wirksamkeitsstudie
  • Press release: Dr. Falk Pharma and Zedira announce completion of phase 1b clinical trial of ZED1227 for the treatment of celiac disease and move on to proof of concept study
  • Press Release: Dr. Falk Pharma GmbH and Zedira enter a phase 1b clinical trial for a celiac disease drug
  • Zedira publication: Microbial transglutaminase has a lower deamidation preference than human tissue transglutaminase on a celiac disease relevant wheat gliadin T-cell epitope
  • Press release: Additional subsidy funding for clinical development of a celiac disease drug
  • Pressemitteilung: Zusätzliche Fördermittel für die klinische Entwicklung eines Zöliakie-Medikamentes
  • Press Release: Cooperation between Zedira and Cardiff University - Transglutaminase 6 is the focus of new research into ataxia
  • Press Release: Dr. Falk Pharma and Zedira enter phase I clinical trials for a celiac disease drug
  • Press release: Zedira receives further funding to develop Factor XIIIa-blockers for safe anticoagulation

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  • Gordon Research Conference on: Transglutaminases in Human Disease Processes

    16.06.2018 - 17.06.2018
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