TOPADUR Pharma AG is a biopharmaceutical start-up company developing a new class of compounds based on their innovative action on the cGMP-Enzyme Regulation System, targeting high medical needs. The company focusing on diabetes mellitus one of the major health concerns affecting 425 million people, and its prevalence is expected to increase to 629 million in 2045. One serious complication of diabetes mellitus is Diabetic Foot Ulcer (DFU) resulting from impaired local blood circulation compromised wound healing, and digital ulcers (DU) in scleroderma, a rare, debilitating autoimmune disease of the connective tissue.
TOPADUR’s compounds correct the deficit in cell-cell communication, which can be the cause of chronic wounds. Its TOP-N53 is a first-in-class wound healing drug candidate, which, when locally applied, increases microcirculation and induces the formation of new blood vessels. TOP-N53 has demonstrated unprecedented potency and efficacy in preclinical models.
In September the company kicked off the first in human trials to evaluate the safety and tolerability of single ascending doses of TOP-N53 in healthy subjects. Results from an interim analysis of an on-going Phase I clinical trial of the first two dose groups suggest that the drug was safe and well-tolerated. Moreover, data from the first two groups demonstrated an increase in skin microcirculation.
“These first results support the important role of TOP-N53 in the treatment of chronic wounds exemplified by diabetic foot ulcer (DFU) and digital ulcers (DU)”, said Reto Naef, Chairman of the Board of Directors and CEO at TOPADUR Pharma AG. “I’m encouraged by these initial clinical trial results of TOP-N53 as they further build on the positive clinical evidence supporting its novel mechanism of action,” he added.