Basking Biosciences Initiates Phase II Trial of BB-031 for Acute Ischemic Stroke
核心洞察
Basking Biosciences (搜索) has dosed the first subject in its Phase II RAISE trial evaluating BB-031 for acute ischemic stroke (搜索) (AIS).
The trial is a multicenter, randomized, placebo-controlled, double-blinded study assessing safety, tolerability, and preliminary efficacy of BB-031.
The study will enroll 156 patients within 24 hours of stroke onset and monitor them over 90 days for radiological outcomes.
Basking Biosciences (搜索) has commenced its Phase II RAISE clinical trial, administering the first dose of BB-031 to a patient with acute ischemic stroke (搜索) (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 (搜索). 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 (搜索), 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 (搜索) 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 (搜索), 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 (搜索) 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 (搜索) reported positive data from a Phase I single ascending dose safety trial of BB-031 in healthy volunteers, supporting its continued development.