Basking Biosciences has announced positive data from a Phase I single ascending dose safety trial of its thrombolytic agent, BB-031, in healthy volunteers.
The company’s new von Willebrand Factor (vWF)-targeting thrombolytic agent BB-031 demonstrated tolerability and safety after a single intravenous dose, and dose-dependent vWF binding patterns and changes in function of platelets.
Healthy volunteers in the Phase I trial were given BB-031 or a placebo in a 6:2 ratio by intravenous bolus at single ascending doses ranging from 0.1mg/kg to 4mg/kg.
It was found that the agent was well tolerated and safe throughout the study period of 28 days, and no significant or treatment-emergent adverse events were reported.
Additionally, BB-031 demonstrated an apparent mean terminal half-life ranging from 18 minutes at 0.1 mg/kg to 61 minutes at 4mg/kg.
Dose-dependent changes in vWF binding were also reported in the study.
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BB-031 is being developed by Basking as a potential solution to the major unmet need in acute thrombosis for a short-acting, rapid-onset drug that can reopen blocked arteries quickly.
Its thrombolytic activity has been designed to be neutralised rapidly during bleeding with the help of a complementary agent, BB-025, which is being developed in tandem.
Basking Biosciences CEO Richard Shea said: “The results of this successful placebo-controlled safety study of BB-031 in 40 healthy participants lay a strong foundation for planned further clinical trials in patients experiencing acute thrombotic conditions.
“We are now preparing to initiate a Phase II clinical proof-of-concept study in patients suffering an acute ischemic stroke with the ultimate goal of being able to safely and effectively treat a much greater number of stroke patients than is possible today.”