ProMetic Begins Rolling Submission of their BLA for Plasminogen
DECEMBER 19, 2016
ProMetic has begun rolling submission of their Biologics License Application (BLA) for plasminogen, their orphan drug treatment of plasminogen congenital deficiency. Their BLA includes data from the Phase 2/3 clinical trial assessing plasminogen which met its primary endpoint in October.
The Phase 2/3 trial reached a 100% success rate with an increase in the blood plasma concentration level of plasminogen as a surrogate target in the patients involved in the trial. Also, all patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment.
ProMetic’s plasminogen previously received Fast Track Designations by the FDA, and ProMetic is highly anticipating accelerated approval for their treatment.
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
What is plasminogen congenital deficiency?
Recently, we spoke with Sarah Bein, MD, who is a physician but also a patient with plasminogen deficiency. She talks about the pathophysiology and genetics of this rare condition.