Topadur submits clinical trial application

The vascular endothelium is a single layer of cells lining blood vessels that plays a key role in regulating migrocirculation and nutritive blood flow, which provide oxygen and nutrients to the tissues in our body. Endothelial dysfunction is the cause of many diseases, which have a high medical need, due to insufficient local blood flow resulting in tissue hypoxis and nutrient deficiency. Topadur has invented a new class of drugs with a dual mode of action. They stimulate capillary blood flow with an unprecedented potency and efficacy, and to address the problems caused by endothelial dysfunction.

Topadur’s lead product TOP-N53 will be used for healing of chronic wounds. Diabetic foot ulcer and chronic wounds are the leading cause of hospitalizations in diabetes. They are responsible for a higher risk of amputation and a huge burden to patients and payors causing annual costs of more than € 12 billion. The biotech start-up founded in 2015 is in transition from a pre-clinical to a clinical stage company. In May the application documents (Clinical Trial Application – CTA) for approval of its phase 1 study for diabetic foot ulcer (DFU) have been submitted. For the first clinical trial in the EU, TOPADUR Pharma Germany, was incorporated in May 2020. 

In addition, the start-up announced that the Journal of Investigative Dermatology accepted a manuscript describing results of in vitro and in vivo tests of TOP-N53. According to a press release, these results demonstrate a remarkable healing-promoting activity of TOP-N53 by targeting the major resident cells in the wound tissue.

(SK)

Picture: Reto Naef, CEO and founder Topadur