Basking Biosciences Begins Phase 2 Trials of Thrombolytic BB-031 for Stroke

COLUMBUS, OH, USA – September 10, 2024, Basking Biosciences, a clinical-stage biopharmaceutical company focused on developing innovative acute thrombolytic therapies, has commenced patient dosing in the RAISE Phase 2 clinical trial for BB-031, a novel treatment targeting acute ischemic stroke (AIS).

"We are thrilled to begin enrolling patients in the RAISE trial," said Richard Shea, CEO of Basking Biosciences. "This step is crucial in our mission to provide a next-generation thrombolytic therapy that could offer a more targeted alternative to traditional fibrinolytics.”

The RAISE trial will assess the safety, tolerability, initial efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of BB-031 in 156 patients who present with acute ischemic stroke within 24 hours of onset. The study is structured as a multicenter, double-blind, placebo-controlled, randomized single ascending dose trial.

Dr. Michael Hill, a professor at the University of Calgary and the Foothills Medical Centre, serves as Clinical Program Advisor and Principal Investigator for the RAISE trial. He emphasized the trial's potential impact: “Targeting the recanalization of blocked intracranial arteries with this novel pharmacology could broaden treatment access and address a significant unmet need in stroke care. Many patients are currently ineligible for existing drug treatments or are unable to reach comprehensive stroke centers in time for advanced endovascular procedures.”

Dr. Shahid M. Nimjee, co-founder and Chief Medical Officer of Basking Biosciences and Professor of Neurosurgery at The Ohio State University Wexner Medical Center, expressed his anticipation for the study: “Patients are eagerly waiting for new treatment options. BB-031 could greatly expand therapeutic possibilities for stroke patients. Additionally, our reversal agent BB-025, which is set to enter clinical development next year, has demonstrated in preclinical studies the ability to neutralize BB-031 within minutes, potentially allowing for safer recanalization procedures.”

Acute ischemic stroke is a leading cause of death and disability globally, comprising 87% of all stroke cases. According to the World Health Organization (WHO), 15 million people suffer from strokes annually, resulting in over 5 million deaths. The incidence of strokes is increasing, particularly in aging populations. In high-income countries, the combined direct and indirect costs of stroke are projected to exceed $826 billion by 2050. Current treatments, including intravenous recombinant tissue plasminogen activators and endovascular mechanical thrombectomy, are available but are applicable to only about 20% of ischemic stroke patients even in the best medical centers. Consequently, approximately 80% of ischemic stroke patients do not receive acute intervention.

Basking Biosciences was established to address the pressing need in acute thrombosis for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries with reversible activity in case of bleeding complications. Utilizing RNA aptamer technology, BB-031 targets von Willebrand Factor (vWF), a key structural component in blood clots, aiming to provide a safer and more effective solution that can significantly increase the number of patients receiving acute revascularization therapy.

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