COLUMBUS, OH (February 9, 2023): Basking Biosciences (Basking), a clinical-stage biopharmaceutical company developing the first reversible thrombolytic therapeutic for ischemic stroke, today presented positive results of a Phase 1 single ascending dose safety study in healthy volunteers of the company’s novel von Willebrand Factor (vWF)-targeting thrombolytic agent, BB-031. BB-031 demonstrated safety and tolerability following a single intravenous dose ranging from 0.1 mg/kg to 4.0 mg/kg and dose-dependent patterns of vWF binding and changes in platelet function. Two oral presentations and two moderated posters concerning BB-031 were presented at the American Heart Association International Stroke Conference (ISC) 2023 being held in Dallas, Texas from February 8 – 10.
Basking is developing BB-031 as a potential solution to the major unmet need in acute thrombosis for a rapid-onset, short-acting drug that is capable of quickly reopening blocked arteries. Uniquely, the thrombolytic activity of BB-031 is designed to be quickly neutralized in the event of bleeding using a complementary agent, BB-025, which the company is developing in tandem.
“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,” said Richard Shea, Chief Executive Officer of Basking. “We are now preparing to initiate a Phase 2 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.”
“vWF is a ubiquitous component of thrombi and a driver of the clotting process,” said Shahid M. Nimjee, M.D., Ph.D., co-founder and Chief Medical Officer of Basking, and Associate Professor and practicing neurosurgeon at the Ohio State University Wexner Medical Center, who discussed the results in an oral presentation. “BB-031 is an RNA aptamer that targets vWF. Non-clinical studies in multiple gold-standard animal models have demonstrated BB-031 can quickly recanalize blocked blood vessels in the brain as late as six hours after stroke onset. Moreover, they also demonstrated reduced infarct volume on MRI in all models.”
Trial Results
In the Phase 1 study, healthy volunteers received BB-031 or placebo (in a 6:2 ratio) by intravenous bolus at single ascending doses ranging from 0.1 mg/kg to 4.0 mg/kg. The study found that BB-031 was safe and well tolerated throughout the 28-day study period, with no significant or treatment-emergent adverse events. BB-031 demonstrated an apparent mean terminal half-life ranging from 18 minutes at 0.1 mg/kg to 61 minutes at 4.0 mg/kg. Dose-dependent changes in vWF binding were observed. An analysis of platelet function showed complete inhibition of clot formation at all doses tested and dose-dependent duration of clotting inhibition and time to return to normal clotting.
About Ischemic Stroke
Acute ischemic stroke (AIS) is the leading cause of combined mortality and morbidity worldwide, and 87% of all strokes are ischemic. According to WHO, 15 million people suffer strokes each year, leading to more than 5 million deaths. Global incidence is rising with aging populations. In the USA, annual direct stroke-related medical costs are projected to exceed $184 billion and indirect costs due to premature mortality and loss of productivity to reach $56 billion by 2030. Intravenous recombinant tissue plasminogen activator (rtPA) and endovascular mechanical thrombectomy are the therapies available to treat acute ischemic stroke. Unfortunately, both treatments are limited by time and clot location respectively, leaving almost 85% of patients without any acute intervention.
About Basking Biosciences
Basking Biosciences is a clinical-stage company founded to solve the biggest need in ischemic stroke therapy – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries within a significantly extended therapeutic window than currently approved therapies, and whose activity can be quickly reversed in the event of bleeding. The company is developing BB-031, a first-in-class RNA aptamer targeting von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process. The company is also developing BB-025 in tandem, a complementary rapid-acting reversal oligonucleotide capable of quickly neutralizing BB-031 pharmacological activity. Non-clinical research in multiple gold-standard animal models demonstrated that BB-031 quickly recanalized blocked blood vessels in the brain, as late as six hours after stroke onset. Basking has successfully completed a Phase 1 single-ascending dose safety study with BB-031 and is initiating a Phase 2 clinical proof-of-concept study in patients suffering from an acute ischemic stroke with the ultimate goal of extending the therapeutic window for thrombolysis compared to currently approved therapies.
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