The trial will enrol 156 acute ischaemic stroke patients presenting within 24 hours of stroke onset. Credit: crystal light/Shutterstock.

Basking Biosciences has dosed the first subject in the Phase II RAISE clinical trial of its lead candidate, BB-031, in patients with acute ischaemic stroke (AIS).

The multicentre, two-part, randomised, placebo-controlled, double-blinded trial aims to assess the safety, tolerability, and preliminary efficacy of BB-031, along with its pharmacokinetic and pharmacodynamic profiles.

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It will enrol 156 patients presenting within 24 hours of stroke onset.

In Part A, approximately 36 subjects will be randomised into a 3:1 ratio to one of three ascending dose groups.

This will determine the dose levels for Part B, where approximately 120 participants will be randomised equally to receive one of two dose levels of BB-031 or a placebo.

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Participants eligible for the trial must have a confirmed diagnosis of an anterior circulation ischaemic stroke, verified through neurovascular imaging.

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They will be monitored over 90 days, with a central blinded reviewer assessing the radiological outcomes.

A Data Safety Monitoring Committee has been established to review safety and efficacy data throughout the study.

Basking Biosciences focuses on addressing the critical need for a rapid-onset, short-acting thrombolytic agent that can be quickly reversed to manage bleeding complications.

BB-031 uses RNA aptamer technology to target von Willebrand Factor (vWF), a key component of blood clots.

Basking Biosciences co-founder and chief medical officer Shahid Nimjee said: “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.”

In February 2023, the company announced positive data from a Phase I single ascending dose safety trial of its thrombolytic agent, BB-031, in healthy volunteers.