Plasminogen Wound Healing for DFUs & TMPs

What is Plasminogen Wound Healing?

Wound healing is an innate mechanism 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.

Prevalence?

Tympanic membrane perforation is considered to be a common condition; however, its incidence in the general population is not well-known. Most TMPs heal spontaneously within a few to several weeks. An estimated 6-20% persists beyond 3 months as a chronic condition, depending on factors such as size, location, and presence or absence of infection. Chronic TMPs can be treated surgically. Non-surgical methods of treatment are currently under investigation.

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

Clinical Trials – Development Stage:

In the fourth quarter of 2017, we received two CTA approvals from the Swedish Medical Products Agency (MPA) to commence the following trials in Sweden:

  • a Phase 1/2a clinical trial of Plasminogen (sub-cutaneous) therapy in patients suffering from chronic TMPs, which began enrolling subjects in 2018; and
  • a Phase 1/2a clinical trial of Plasminogen (sub-cutaneous) therapy in patients suffering from DFUs, which has not yet started.