Plasminogen Wound Healing for DFUs & TMPs

What is Plasminogen Wound Healing?

Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot. Wound healing is an innate mechanism of action that works reliably most of the time. A key feature of wound healing is stepwise repair of lost extracellular matrix (ECM) that forms the largest component of the dermal skin layer. But in some cases, certain disorders or physiological insult disturbs the wound healing process. Diabetes mellitus is one such metabolic disorder that impedes the normal steps of the wound healing process. Many studies show a prolonged inflammatory phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue and a parallel reduction in wound tensile strength.

Diabetic foot ulcers and chronic tympanic membrane perforations are conditions where impaired wound healing represents a significant unmet clinical need. Local administration of plasminogen has demonstrated promise in animal models and may prove a significant addition to the tools available to physicians caring for these patients.

Clinical Trials – Development Stage:

Clinical trials in patients with diabetic foot ulcers (DFUs) and in patients with tympanic membrane perforations (TMPs) are initiating in Sweden. In the fourth quarter of 2017, we received two CTA approvals from the Swedish Medical Products Agency (MPA) to commence the following trials:

  • a Phase 1b/2 clinical trial of its Plasminogen (sub-cutaneous) therapy in patients suffering from DFUs; and
  • a Phase 1b/2 clinical trial of its Plasminogen (sub-cutaneous) therapy in patients suffering from chronic TMPs.