Plasminogen Wound Healing for DFUs & TMPs

What is Plasminogen Wound Healing?

Wound healing is a physiologic process that works well most of the time but can be disrupted. Abnormal wound healing represents a significant unmet medical need.

One example is chronic tympanic membrane perforation (TMP). Most TMPs heal spontaneously within a few to several weeks. However, an estimated 6-20% persist beyond 3 months as a chronic condition, depending on factors such as size, location, and presence or absence of infection. TMP can cause hearing loss, recurrent ear infection, pain, ringing/buzzing in the ears, and dizziness. Chronic TMP may require surgery and various types of grafts. A novel method of non-surgical treatment that offers the potential for a more natural tissue repair would be an attractive alternative. Although TMP is considered a common disorder, its incidence in the general population is not well-known.

Plasminogen has been implicated in multiple cell processes during all phases of wound healing – inflammatory, proliferative, and remodeling. These processes include fibrin degradation, platelet activation, release of cytokines and growth factors, clearance of apoptotic cells, activation of keratinocytes and epithelial-to-mesenchymal transition of fibroblasts, cell migration, and extracellular matrix degradation. Local administration of plasminogen has demonstrated promise in animal models of wound healing and may prove to be a useful adjunct for the clinical treatment of challenging wounds.

Clinical Trials – Development Stage:

In the fourth quarter of 2017, we received CTA approval from the Swedish Medical Products Agency (MPA) for a phase 1/2a clinical trial of subcutaneous plasminogen therapy in patients suffering from chronic TMP. The study began enrolling subjects in 2018. Nine adult subjects have been enrolled on the completed low dose cohort of the study. A new, more concentrated plasminogen formulation is under development. Once available, study enrolment will resume and the new formulation will be used to treat subjects at higher dose levels. The study is being conducted in Sweden, under the supervision of Dr. Cecilia Engmér Berglin, MD, PhD from the Department of Otorhinolaryngology at Karolinska University Hospital in Stockholm, Sweden.