Basking Biosciences Presents Safety and Dose-Escalation Study for Reversible Thrombolytic Agent for Ischemic Stroke

February 9, 2023—Basking Biosciences, an Ohio-based clinical-stage biopharmaceutical company developing a reversible thrombolytic therapy for ischemic stroke, announced the presentation of positive results of a phase 1 single ascending-dose safety study in healthy volunteers of the company’s BB-031 thrombolytic agent, which is a first-in-class RNA aptamer targeting von Willebrand Factor (vWF).

According to the company, the phase 1 study was composed of healthy volunteers who 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.

Data on BB-031 were revealed in two oral presentations and two moderated posters at the American Stroke Association’s International Stroke Conference 2023 held February 8–10 in Dallas, Texas, and virtually.

Basking is developing BB-031 as a rapid-onset, short-acting drug capable of quickly reopening blocked arteries to treat acute thrombosis. 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. BB-025 is a rapid-acting reversal oligonucleotide capable of quickly neutralizing BB-031 pharmacologic activity.

Shahid M. Nimjee, MD, Associate Professor and practicing neurosurgeon at the Ohio State University Wexner Medical Center in Columbus, Ohio is cofounder and Chief Medical Officer of Basking.

“vWF is a ubiquitous component of thrombi and a driver of the clotting process,” commented Dr. Nimjee in the company’s press release. “BB-031 is an RNA aptamer that targets vWF. Nonclinical studies in multiple gold-standard animal models have demonstrated BB-031 can quickly recanalize blocked blood vessels in the brain as late as 6 hours after stroke onset. Moreover, they also demonstrated reduced infarct volume on MRI in all models.”

Richard Shea, Chief Executive Officer of Basking, commented in the press release, “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 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.”