Basking Biosciences has announced that the first participants have been dosed in a phase-one clinical study of BB-025—a rapid-acting reversal agent designed to specifically bind to and neutralise BB-031, the company’s investigational thrombolytic drug intended for the treatment of acute ischaemic stroke.
The phase-one study, being conducted in Australia, will assess the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BB-025. It will first evaluate BB-025 administered in single ascending-dose cohorts of healthy volunteers randomised to receive BB-025 or placebo. After establishing the safety and tolerability of BB-025 alone, subsequent cohorts of healthy volunteers will receive BB-031 followed by BB-025 to evaluate how rapidly and predictably BB-025 reverses BB-031’s activity in humans.
“The ability to reverse treatment represents a paradigm shift in the science of treating stroke,” said Shahid Nimjee, co-founder and chief medical officer of Basking. “While the majority of patients receiving BB-031 for acute ischaemic stroke are unlikely to require reversal, in cases of bleeding or urgent surgery, having that capability adds an important layer of control, safety and flexibility to care.”
Following completion of this phase-one study, BB-025 will be integrated into the company’s ongoing clinical development programme for BB-031 for acute ischaemic stroke, supporting Basking’s goal of advancing targeted, reversible therapies for stroke and beyond, as stated in a press release.
“This first-in-human study of BB-025 marks an important milestone in our clinical development strategy,” commented Julia Owens, chief executive officer (CEO) of Basking. “It builds on our progress with BB-031 and underscores our aim to enhance safety, flexibility and clinician confidence in stroke treatment.”
According to Basking, multiple non-clinical studies of BB-025 have demonstrated rapid and durable reversal of BB-031 activity within minutes of administration, supporting the potential for precise control of thrombolytic effects—findings that provided the foundation for advancing BB-025 into clinical evaluation.
