Press Release
6.7.21

TOPADUR Pharma AG announces completion of TOP-N53 First-in-Man Study

Zurich-Schlieren, Switzerland, July 6th, 2021. TOPADUR Pharma AG, a biopharmaceutical start-up company today announced the completion of a Phase 1 dose escalation study of its lead compound, TOP-N53, a first-in-class wound healing drug candidate. The study was designed to allow for an increase to the next higher dose with six patients per dose level and a total of 30 healthy subjects were enrolled. As a result of the excellent safety profile of TOP-N53, the clinical study advanced through all five intended dose levels. The final results of this study will be reported once full datasets are available for pharmacokinetics, pharmacodynamics, and clinical observations for all enrolled subjects. "The absence of dose-limiting toxicity gives us great confidence that TOP-N53 will be safe for use in patients following longer-term administration," said Reto Naef, Chairman of the Board of Directors and CEO at TOPADUR Pharma AG. “I’m encouraged by the completion of this study as this is an essential first step into the clinical development of TOP-N53” commented Dr. Naef.

Download DocumentDokument herunterladen
27.5.21
News

Innosuisse innovation project starting May 2021

TOPADUR in collaboration with the University Hospital of Zurich and the University of Zurich was awarded CHF 859k by Innosuisse.

Read more
5.10.21
Press Release

TOPADUR Pharma AG announces positive results from TOP-N53 First-in-Human Study

TOPADUR Pharma AG announces positive results from a First-in-Human study evaluating the safety, tolerability and efficacy of TOP-N53.

Read more
15.10.21
Press Release

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

EMA grants TOP-N53 Orphan Drug Designation for the Treatment of Digital Ulcers in Systemic Sclerosis.

Read more