Thrombolytic Science has received Investigational New Drug (IND) application clearance for mutant prourokinase from the US Food & Drug Administration (FDA).
The recombinant fibrinolytic pro-enzyme is designed to dissolve clots in patients with thrombosis without triggering bleeding, and has shown promise in clinical trials.
In the Phase II DUMAS trial, stroke patients were found to benefit from the therapeutic — though this trend was not significant, according to researchers.
To further determine the impact of mutant prourokinase, the company will run a US-based clinical trial to confirm the safety and tolerability of the drug in healthy volunteers.
There will also be a Phase II trial run in the UK for myocardial infarction, following approval from the MHRA.
"In the natural, physiological mechanism of clot lysis, while tissue plasminogen activator (tPA) initiates clot lysis, prourokinase completes the dissolution of the fibrin clot," explained TSI's co-founder and MD, Victor Gurewich. "Physiological fibrinolysis requires a mini bolus of r-tPA followed by an infusion of low dose 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 bloodflow earlier."
TSI's CEO, Alexis Wallace, commented: "Our approach to fibrinolytic therapy has the potential to transform the treatment landscape for thrombotic conditions, offering patients a faster, safer and more effective reperfusion option,"
"This IND clearance is a significant step toward expanding access to our low-dose fibrinolytic treatment for broader patient populations globally."