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DecoDerma granted orphan-drug designation for rare disease epidermolysis bullosa by FDA

Published on 2.2.2023
Tampere University
DecoDerma is happy to announce that U.S. Food & Drug administration (FDA) has granted orphan-drug designation for DecoDerma´s intended drug for lethal rare disease epidermolysis bullosa (EB).

The DecoDerma team is led by Professor & Chief Surgeon Tero Järvinen (M.D., Ph.D.) from Tampere University (Finland). The team is developing a potentially life-saving drug for rare pediatric skin disease, epidermolysis bullosa. Their molecule is a recombinant, multi-functional fusion protein that has both a targeting peptide (tCRK peptide) for a delivery to normal skin and skin wounds and Decorin (DCN) anti-inflammatory and anti-fibrotic protein as an active therapeutic component. The team has demonstrated the best-in-class position in the lethal, pre-clinical disease model of EB.

The DecoDerma team is focused to create novel treatment for lethal skin disease, EB, but the molecule has other potential disease indications; among them suppression of tumor growth.

DecoDerma has carried out proof-of-concept studies successfully, already received the orphan drug designation for their molecule from EMA in Europe and the company was selected as one of the most promising startup companies in Scandinavia by both the Nordic Innovation Fair (NIF) and the Nordic Life Science days (NLSD) in 2022. Recently, SPARK Stanford and SPARK Global startup incubator programs selected DecoDerma among the best 10 global academic biotech startup companies. DecoDerma is currently raising capital for moving the molecule to clinical trials in EB patients to address the unmet medical need in one of the most devastating diseases in mankind.

More info can be found on our project website DecoDerma.

Orphan drug designation at FDA