COLUMBUS, Ohio--(BUSINESS WIRE)--Basking Biosciences (Basking), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, today announced that the first patients have been dosed in RAISE, a Phase 2 clinical trial evaluating BB-031 in patients presenting with acute ischemic stroke (AIS).
“We are excited to announce the initiation of patient enrollment in the RAISE trial,” said Richard Shea, Chief Executive Officer of Basking. “This milestone brings us closer to delivering a next-generation therapy that we believe will offer patients a new targeted thrombolytic option beyond traditional fibrinolytics.”
RAISE is a two-part, Phase 2 clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of BB-031 in 156 patients with acute ischemic stroke who present within 24 hours of onset. The trial is a multicenter, double-blind, placebo-controlled, randomized single ascending dose study. For additional trial details, see clinicaltrials.gov.
“Effectively and safely targeting recanalization of acutely occluded intracranial arteries with novel pharmacology has the potential to expand access to treatment for stroke patients and will address a significant unmet need in acute stroke care,” said Michael Hill, M.D., Professor for the Departments of Clinical Neurosciences, Community Health Sciences, Medicine and Radiology at the University of Calgary and Foothills Medical Centre, and Clinical Program Advisor and Principal Investigator of RAISE. “Many patients are simply not eligible for current drug treatments or cannot reach a comprehensive stroke center in time to benefit from advanced endovascular treatment.”
“We are thrilled to have this study underway – patients are waiting,” said Shahid M. Nimjee, M.D., Ph.D., co-founder, Chief Medical Officer of Basking, and Professor of Neurosurgery and Surgical Director of the Comprehensive Stroke Center at The Ohio State University Wexner Medical Center. “We believe BB-031 will greatly expand the therapeutic options for stroke patients. Recanalization may also be performed more safely given that our reversal agent, BB-025, which will enter clinical development next year, has been shown in preclinical studies to neutralize BB-031 within minutes.”
About Acute 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 high-income countries alone, annual direct stroke-related medical costs plus indirect costs due to premature mortality and loss of productivity are projected to exceed $826 billion by 2050. While intravenous recombinant tissue plasminogen activators (alteplase, tenecteplase) and endovascular mechanical thrombectomy are available to treat acute ischemic stroke, either or both treatments can only be applied to a ceiling of 20% of all ischemic stroke patients even in the best centers worldwide. Among ischemic stroke patients, 80% or more do not receive acute intervention.
About Basking Biosciences
Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to solve the biggest need in acute thrombosis – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries, and whose activity can be quickly reversed in the event of a bleeding complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be safer, more effective, and able to significantly expand the population receiving acute revascularization therapy.
For more information, visit BaskingBiosciences.com and follow us on LinkedIn.
