Thrombolytic Science Receives FDA Investigational New Drug Clearance

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Thrombolytic Science (TSI) has received approval from the US Food and Drug Administration (FDA) regarding its Investigational New Drug application. Said application relates to the clinical-stage biotech company’s mutant for prourokinase (mproUK), a recombinant fibrinolytic pro-enzyme. This reconfirms the safety and tolerability of TSI’s mproUK in healthy volunteers.

Alexis C. Wallace, MSc. Eng., MBA, CEO of TSI said, “We are thrilled to achieve this important milestone with the FDA clearance for our first U.S. clinical trial of mproUK. Our innovative approach to fibrinolytic therapy has the potential to transform the treatment landscape for life-threatening thrombotic conditions, offering patients a faster, safer, and more effective reperfusion option. Following promising Phase II results from the DUMAS trial in stroke patients in the Netherlands, we’re now advancing to a Phase II trial in the UK for myocardial infarction following MHRA approval. This IND clearance is a significant step toward expanding access to our low-dose fibrinolytic treatment for broader patient populations globally.”

Naturally, the physiological mechanism of clot lysis. While tissue plasminogen activator (tPA) initiates clot lysis, prourokinase completes the dissolution of the fibrin clot.

Victor Gurewich, MD, Co-Founder and Discoverer of Prourokinase at TSI said, “This difference is comparable to the starter of a car and its engine. tPA is like the starter, whereas prourokinase is the engine. Physiological fibrinolysis requires a mini bolus of r-tPA followed by an infusion of a low dose of mproUK. In recent clinical studies, this treatment has been shown to be free of bleeding risk and rethrombosis while having the potential to re-establish blood flow earlier and being more cost-effective than in-hospital surgical solutions.”