Press Release
15.10.21

EMA grants TOP-N53 Orphan Drug Designation for the Treatment of Digital Ulcers

Zurich-Schlieren, Switzerland, October 15th, 2021. TOPADUR Pharma AG, a clinical-stage biopharmaceutical start-up company developing first-in-class drugs for aging diseases, today is pleased to announce that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to TOP-N53, the company’s lead product, for the treatment of digital ulcers in patients with systemic sclerosis (SSc).

“This ODD by EMA marks an important milestone in the clinical development of TOP-N53 and supports our conviction that innovative treatments for chronic wounds are urgently needed” said Reto Naef, Chairman of the Board of Directors and CEO at TOPADUR Pharma AG. “TOP-N53 potency, tolerability and efficacy were demonstrated in First-in-Human study. We believe that this novel drug candidate has the potential to transform the standard of care of digital ulcers in SSc patients and to provide a valuable treatment option for this disabling condition.”

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