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.
TOPADUR announces the submission of an application to the European Medicines Agency to receive Orphan Drug Designation Status.Read more