RESEARCH TRIANGLE, North Carolina — August 25, 2026

Basking Biosciences announced positive topline Phase 1 data for BB-025, an investigational rapid-acting reversal agent being developed alongside the company’s acute ischemic stroke therapy BB-031. The first-in-human study enrolled 60 healthy volunteers and evaluated BB-025 administered intravenously either alone or following BB-031. The results showed that BB-025 completely and rapidly reversed BB-031 activity within five minutes, restoring von Willebrand factor (vWF) activity and platelet function. The findings represent an important development milestone for Basking’s strategy to create a reversible thrombolytic approach for acute ischemic stroke, where rapid treatment must be balanced against bleeding risk.

BB-025 Rapidly Reversed BB-031 Activity

The primary objective of the Phase 1 study was to evaluate the safety and tolerability of escalating single doses of BB-025, administered as intravenous bolus injections at doses up to 12 mg/kg. The study also assessed the reversal capability of BB-025 after BB-031 administration at doses up to 6 mg/kg. When given following BB-031, BB-025 produced complete, rapid and stable reversal of thrombolytic activity within five minutes, with restoration of vWF activity and platelet function. Importantly, the reversal effect remained demonstrable at both 30 minutes and five hours after BB-031 administration, supporting the potential for a clinically useful reversal window. Across the 60 participants, BB-025 was generally safe and well-tolerated, with no deaths, life-threatening treatment-emergent adverse events or serious adverse events reported.

Reversible Thrombolysis Could Differentiate BB-031

BB-031 is an investigational RNA aptamer designed to selectively inhibit von Willebrand Factor (vWF), a key mediator involved in clot initiation, growth and stabilization. By targeting vWF, Basking aims to provide rapid thrombolytic activity for patients with acute ischemic stroke (AIS). BB-025 is specifically designed to bind and neutralize BB-031, creating a built-in mechanism for rapidly reversing its activity when clinically necessary. This approach could be particularly relevant when patients experience bleeding complications or require urgent surgical intervention. According to Basking, the combination represents a differentiated development strategy because BB-031 is being developed together with a direct-acting reversal agent. The Phase 1 findings provide early clinical evidence that the reversal mechanism can work rapidly and remain durable after administration.

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Phase 1 Results Support Next BB-031 Clinical Development

The positive topline findings provide Basking with an important clinical foundation as it prepares for the next stage of development of its BB-031 and BB-025 program. The company plans to present detailed Phase 1 results at a future medical meeting and intends to discuss incorporation of BB-025 into the BB-031 acute ischemic stroke clinical development program with the FDA. The potential significance of the program lies in its paired approach: BB-031 is designed to restore blood flow by targeting vWF, while BB-025 is designed to rapidly turn off that activity when required. If subsequent clinical studies confirm efficacy and safety in stroke patients, this reversible model could provide clinicians with greater control over thrombolytic treatment. However, the current results are limited to healthy volunteers, so whether the approach improves outcomes in patients with acute ischemic stroke remains to be demonstrated in later-stage clinical trials.

Source:Basking Biosciences ,press relese