Basking Biosciences has commenced its Phase II RAISE clinical trial, administering the first dose of BB-031 to a patient with acute ischemic stroke (AIS). This multicenter, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profiles, and preliminary efficacy of BB-031.
Trial Design and Objectives
The RAISE trial is a randomized, placebo-controlled, double-blinded study that plans to enroll 156 patients presenting within 24 hours of experiencing an acute ischemic stroke. The trial is divided into two parts. Part A will randomize approximately 36 subjects in a 3:1 ratio across three ascending dose groups to determine appropriate dose levels. Part B will then randomize around 120 participants equally to receive one of two dose levels of BB-031 or a placebo.
Eligible participants must have a confirmed diagnosis of anterior circulation ischemic stroke, verified through neurovascular imaging. Patients will be monitored for 90 days, with a central blinded reviewer assessing radiological outcomes. A Data Safety Monitoring Committee will oversee the safety and efficacy data throughout the study.
BB-031: A Novel Approach to Thrombolysis
BB-031 is an RNA aptamer designed to target von Willebrand Factor (vWF), a key component in blood clot formation. Basking Biosciences is focused on developing a rapid-onset, short-acting thrombolytic agent that can be quickly reversed to mitigate bleeding complications.
Shahid Nimjee, co-founder and chief medical officer of Basking Biosciences, stated, "We are thrilled to have this study underway – patients are waiting. We believe BB-031 will greatly expand the therapeutic options for stroke patients. Recanalisation 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."
Context of Ischemic Stroke Treatment
Ischemic stroke is a major cause of disability and death worldwide. Current treatments, such as thrombolytic agents like tissue plasminogen activator (tPA), have limitations, including a narrow therapeutic window and the risk of bleeding complications. There is a significant unmet need for therapies that can rapidly and safely restore blood flow to the brain following a stroke.
In February 2023, Basking Biosciences reported positive data from a Phase I single ascending dose safety trial of BB-031 in healthy volunteers, supporting its continued development.
