Basking Biosciences has initiated dosing of the first patients in Part B of its Phase 2 RAISE trial evaluating BB-031, an investigational reversible thrombolytic therapy for acute ischemic stroke. The clinical-stage biopharmaceutical company simultaneously announced the appointment of Julia C. Owens, Ph.D., as chief executive officer and the release of $27.5 million in financing to support the expanded trial.
Novel Mechanism Targets Critical Clotting Pathway
BB-031 is an investigational RNA aptamer designed to inhibit von Willebrand Factor (vWF), a key mediator of platelet adhesion and thrombus formation. By precisely targeting this critical pathway, BB-031 is intended to enable targeted, controllable thrombolysis that could extend the treatment window and broaden treatment opportunities for patients with acute ischemic stroke.
The therapy is paired with BB-025, an investigational rapid-acting reversal agent designed to specifically bind and neutralize BB-031. Administered as a single intravenous bolus, BB-025 enables rapid and durable reversal of BB-031's thrombolytic activity, providing an "on-off switch" mechanism for physician control during acute stroke treatment.
Expanded Trial Design Based on Encouraging Early Results
Progression into Part B was supported by encouraging early results from Part A and the recommendation of the Data Safety Monitoring Committee (DSMC). Part A enrolled 48 patients across three ascending-dose cohorts (0.5, 1.5, and 4.0 mg/kg vs. placebo), with enrollment increased from the originally planned 36 patients to double the size of the top-dose cohort based on the encouraging safety profile observed.
Part B has been expanded from approximately 120 patients to 180 participants, reflecting confidence in BB-031's profile shown in Part A. The increase is intended to enable evaluation of potential treatment effects on the NIH Stroke Scale (NIHSS), a measure correlated with meaningful functional outcomes. Part B will evaluate BB-031 at doses of 2.0 mg/kg and 6.0 mg/kg in a stepwise design, alongside a placebo group.
The RAISE trial is a two-part, multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating BB-031 in patients with acute ischemic stroke who present within 24 hours of symptom onset. The primary objectives are to assess safety, tolerability, and pharmacokinetics/pharmacodynamics, with secondary endpoints evaluating vessel recanalization, infarct volume, NIHSS score change, and functional outcomes at 90 days.
Leadership Transition and Financing Support
The progression to Part B triggered the release of the second $27.5 million tranche of the company's $55 million financing, first announced in January 2024. The financing is led by ARCH Venture Partners, with participation from Insight Partners, Platanus, Solas BioVentures, RTW, Longview Ventures, and others. The new funds will support the execution of Part B of the Phase 2 RAISE trial and a planned Phase 1 study of BB-025.
Dr. Owens brings extensive leadership experience in biopharmaceutical company building and drug development, having served as CEO of Ananke Therapeutics and founder and CEO of Millendo Therapeutics. She has held board roles at both emerging and publicly traded companies and currently serves on the board of Biotechnology Innovation Organization (BIO).
"Basking's innovative science, its unparalleled dedication to the stroke community, and the caliber of its existing leadership drove my interest in joining the team," said Dr. Owens. "As I deepen my understanding of the company and its science, I'm energized to partner with the leadership team to build on encouraging Phase 2a results and realize the potential of BB-031 to reshape stroke care."
Richard Shea, who has served as Basking's CEO since the company's founding in 2019, will transition to president and chief operating officer, ensuring leadership continuity as the company advances into later-stage clinical development.
Addressing Critical Treatment Gap
Acute ischemic stroke accounts for 87 percent of all strokes and is the leading cause of combined mortality and morbidity worldwide. According to the World Health Organization, 15 million people suffer a stroke each year, resulting in more than 5 million deaths. In high-income countries alone, annual direct and indirect stroke-related costs are projected to exceed $826 billion by 2050.
Currently available therapies, including intravenous thrombolytics and mechanical thrombectomy, reach no more than 20 percent of patients, even in the best stroke centers. As a result, 80 percent or more of patients with ischemic stroke receive no acute intervention today.
"Despite progress in care, most patients with acute ischemic stroke remain ineligible for currently approved therapies, underscoring the need for new approaches," said Shahid M. Nimjee, M.D., Ph.D., co-founder and chief medical officer of Basking Biosciences, and Professor of Neurosurgery and Surgical Director of the Comprehensive Stroke Center at The Ohio State University Wexner Medical Center. "Our commitment is to change that by advancing BB-031 through Phase 2b and beyond, to deliver a therapy that expands access and addresses this critical gap in stroke care."
The trial is being conducted at sites across North America and Australia, with anticipated site activation in the United Kingdom.
