Bioxodes Prepares Pivotal Trial for First-Ever Haemorrhagic Stroke Drug

Bioxodes is advancing its lead candidate BIOX-101 into a pivotal trial for haemorrhagic stroke, following promising results from its Phase IIa BIRCH study (NCT05970224). The recombinant protein showed trends toward reducing perihaematomal oedema and haemorrhage volume, while improving functional recovery at day 90 compared with standard care.

The company is currently determining whether to proceed to Phase IIb or Phase III, pending regulatory input. EMA’s PRIME submission is expected by Q1–Q2 2026, alongside an FDA pre-meeting in January 2026 to define trial requirements.

If approved, BIOX-101 could become the first pharmacological treatment for haemorrhagic stroke, addressing a major unmet need currently managed only through surgery and blood pressure control. The drug’s dual action—limiting neutrophil activation and blocking coagulation without increasing bleeding—could make it transformative. Bioxodes also plans to explore ischemic stroke applications by 2028.

02-11-2025