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.”
TOPADUR announces the submission of an application to the European Medicines Agency to receive Orphan Drug Designation Status.Read more
The European Patent Office granted a patent covering the lead drug candidate, TOP-N53 used for the treatment of chronic wounds.Read more
Dual-Mode Vasodilator M119 Delivery to Hair Follicle via Dissolving Microneedle for Advanced Alopecia Treatment.Read more