Clinical development plan
We focus on delivering transformative treatment for chronic wounds where there is little to no pharmacologically active treatment available today.
We have shown in a number of investigator led studies that treatment with plasminogen can heal chronic wounds where futile progress had been made with traditional care. Production of our drug product, recombinant plasminogen, will start early fall 2021 and we expect to start our first clinical Phase I study by the end of 2022.
For our initial clinical proof-of-concept studies we will focus on wound healing in diabetic patients. Diabetic patients are a patient group that has an impaired wound healing capacity where development of chronic wounds is a common and disabling complication. Diabetic wounds with impaired healing capacity are the most severe types of chronic wounds that every year affect millions of people. Worldwide, 10-15 million patients undergo amputation each year due to non-healing foot ulcers. Current treatment of diabetic ulcers comprises mainly conventional wound treatment with different types of dressings, bandages, and antibiotics. At present, no biologically active treatment that speeds up the healing of diabetic wounds exists that is widely used on the market. In addition, studies have shown that diabetics due to uncontrolled blood sugar levels have a decreased plasminogen activity.
We plan to further expand our clinical development into ear-drum perforations and periodontitis where pre-clinical studies have shown beneficial use of plasminogen.