EMA Grants Orphan Status to Tarix's EB Candidiate
The European Medicines Agency (EMA) granted Orphan Drug status to Tarix Orphan LLC’s lead compound, TXA127, for the treatment of epidermolysis bullosa (EB).
TXA127 is a pharmaceutical grade formulation of the naturally occurring peptide Angiotensin (1-7), which Tarix Orphan is developing for the treatment of a number of orphan and genetic diseases, including EB. TXA127 has U.S. Orphan Drug and Fast Track designations and is expected to enter Phase 2 clinical testing in DMD in early 2018.
Orphan status is granted by the EMA to promote the development of products that demonstrate promise for the treatment of rare diseases. Orphan drug designation entitles Tarix Orphan to a 10-year period of marketing exclusivity in Europe for TXA127 if it is approved by the EMA for the treatment of epidermolysis EB.