Bioxodes Secures €5.5 Million to Advance First-in-Class Stroke Treatment Toward Pivotal Trial
Key Insights
Bioxodes (search) raised €5.5 million in Series A extension funding to advance BIOX-101, a first-in-class treatment for intracerebral hemorrhage (search), toward a pivotal Phase 2b trial planned for 2027.
The company's BIRCH Phase 2a trial demonstrated strong safety and efficacy signals in ICH patients, with unanimous DMC recommendation to proceed to larger Phase 2b study.
BIOX-101 represents a breakthrough approach with dual anticoagulant and anti-inflammatory mechanisms that reduce clotting without increasing bleeding risk.
Belgian biopharmaceutical company Bioxodes (search) has secured €5.5 million in Series A extension funding to advance preparations for a pivotal Phase 2b trial of BIOX-101, its first-in-class treatment for intracerebral hemorrhage (search) (ICH). Newton Biocapital (search) led the round as a new investor, alongside existing shareholders, bringing the company's total Series A financing to approximately €17.5 million.
The funding enables Bioxodes (search) to continue preparations for launching the potentially registrational Phase 2b trial in 2027, with commercial launch possible as early as the second half of 2030 in the United States and early 2031 in Europe.
Strong Phase 2a Results Drive Investment Decision
Bioxodes (search) announced strong interim results from its BIRCH Phase 2a trial in September, meeting the safety endpoint and achieving highly encouraging efficacy signals across clinical and biomarker measures. The Data Monitoring Committee unanimously recommended proceeding to a larger Phase 2b trial based on these promising results.
"Our Phase 2a data clinical results in ICH patients are very promising and the principal investigator is encouraging us to push forward rapidly with registrational studies," said Marc Dechamps, CEO at Bioxodes (search). "The funding advances preparations for the pivotal Phase 2b trial and may enable us to bring BIOX-101 to patients as early as the second half of 2030."
Alain Parthoens, Chief Executive Officer at Newton Biocapital (search), highlighted the clinical significance: "The BIOX-101 Phase 2a trial yielded very convincing data in intracerebral hemorrhage (search), an often deadly disease that presents an important unmet medical need. While the company is breaking new ground in this indication, we believe the path to registration is clear, with objective endpoints that look achievable based on the data at hand."
Addressing Critical Unmet Medical Need
Intracerebral hemorrhage (search) represents a devastating condition with no approved therapies, accounting for up to 40% of all stroke (search)-related deaths despite comprising just 15% of stroke cases. The condition carries a mortality rate approaching 50% at 30 days, with approximately half of all ICH-related deaths occurring within the first 24 hours. Fewer than 20% of survivors achieve functional independence after six months, often due to secondary damage from untreatable bleeding and associated inflammation.
Current treatment limitations stem from the inability to use marketed anticoagulants, which invariably carry risks of exacerbating bleeding when used to prevent secondary ischemic lesions after ICH.
Novel Dual Mechanism of Action
BIOX-101 is a proprietary recombinant version of a small protein found in tick saliva (Ixodes ricinus), designed to inhibit harmful secondary effects of hemorrhagic stroke (search) including secondary ischemia, neuroinflammation, and neuronal damage. Unlike currently marketed anticoagulants, BIOX-101 reduces clotting without increasing bleeding risk by targeting Factors XIa and XIIa of the intrinsic coagulation pathway.
The drug candidate also demonstrates potent anti-inflammatory effects through a second mechanism, inhibiting neutrophil activation and their release of neutrophil extracellular traps (NETs). These DNA filaments can cause excessive inflammation, contributing to edema expansion, brain damage, and blood-brain barrier disruption.
Expanding Development Pipeline
Beyond ICH, Bioxodes (search) plans to develop BIOX-101 for treating ischemic stroke (search) and is preparing Phase 2 trials for acute ischemic stroke and an undisclosed indication. To fund these future clinical trials, the company has launched an €80 million Series B fundraising and is actively discussing potential partnerships.
The company holds both granted and pending patents worldwide associated with BIOX-101, with research supported by the Walloon Region. Bioxodes (search) positions its lead asset as the foundation for an innovative pipeline targeting thromboinflammatory diseases.