Bioxodes reports positive Phase 2a data for BIOX-101 in ICH

Bioxodes has presented final Phase 2a results for BIOX-101, its dual-acting FXIa/FXIIa inhibitor, at the European Stroke Organisation Conference in Maastricht, reporting that the BIRCH trial met its primary safety endpoint and generated encouraging efficacy signals across all pre-specified measures in 23 patients with spontaneous intracerebral haemorrhage (ICH).

The open-label, randomised 3:1 study administered BIOX-101 as a 48-hour intravenous infusion within 24 hours of symptom onset. No mortality and no microhemorrhages were recorded at Day 7 in either arm. Three serious adverse events in two BIOX-101-treated patients (11.8%) were assessed as unlikely drug-related or unrelated, compared with three SAEs in two standard-of-care patients (33.3%).

Trial data

The efficacy signals reported at ESOC were striking given the small cohort. At Day 3, haemorrhage volume in the BIOX-101 arm decreased by 2.19 mL, against a 3.85 mL increase in the standard-of-care arm. Perihematomal oedema growth — a validated surrogate for functional outcome — reached 6.44 mL in the treated group versus 10.46 mL in controls. Secondary ischaemic lesions at Day 7 were observed in 5.9% of BIOX-101 patients compared with 16.7% in the control arm, and a more stable neutrophil-to-lymphocyte ratio suggested attenuation of the acute systemic inflammatory response. Functional independence at Day 90, defined as a modified Rankin Scale score of 0–2, was achieved by seven of 16 evaluable BIOX-101 patients and none of five control patients.

Robin Lemmens, professor at University Hospitals Leuven and BIRCH principal investigator, said the directional findings on haemorrhage volume, oedema growth and functional recovery, combined with a clean safety profile, "provide a strong basis for advancing BIOX-101 into the planned pivotal adaptive Phase 2b/3 trial."

Regulatory path and funding

Bioxodes said regulatory discussions with both the FDA and EMA have validated a single adaptive Phase 2b/3 design targeting up to 500 patients, with functional outcomes as the primary endpoint and perihematomal oedema as a key secondary. Chief executive Marc Dechamps indicated that compelling Phase 2b interim data could be sufficient to support an accelerated approval pathway, with a potential US launch towards the end of 2030 and European approval in 2031. These are projections contingent on trial success and regulatory outcomes; investors should treat the timeline accordingly. The company is actively raising a €70 million Series B to finance the pivotal trial, manufacturing scale-up, and registration activities.

The ICH space represents one of the few remaining neurovascular indications without an approved pharmacological treatment, a gap that has persisted despite decades of investigation into haemostatic and neuroprotective approaches. The FXIa/FXIIa axis has attracted significant industry attention as a mechanism that may reduce thromboinflammatory injury without meaningfully increasing bleeding risk — a key concern in a condition where anticoagulants are generally contraindicated. Several larger biopharmaceutical companies have FXIa-targeting programmes in cardiovascular indications, though BIOX-101's application to ICH remains a relatively uncontested niche. The accelerated approval route Bioxodes is pursuing would require the FDA to accept perihematomal oedema or a similar biomarker as reasonably likely to predict clinical benefit, a regulatory read-across that has not yet been established for ICH and which the agency will scrutinise carefully.

The €70 million Series B target is substantial for a Belgian clinical-stage biotech at this development stage, and the company's ability to initiate the pivotal trial rests on completing that raise. Bioxodes said it is in advanced discussions with potential partners and investors but has not confirmed a lead investor or close date.