- Final Phase 2a data from the BIRCH trial of BIOX-101 in acute intracerebral hemorrhage, selected for a Late-Breaking Science oral presentation
- New data show statistically significant improvements across multiple secondary endpoints
- Presentation covers safety, imaging, and functional outcomes to Day 360
- Presentation on October 21 at the 18th World Stroke Congress in Seoul, South Korea
- Bioxodes plans to host a KOL event and investor webcast following the presentation
Gosselies, Belgium, September 24, 2026 (8:30 a.m. CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announced that the complete dataset from its Phase 2a BIRCH trial of BIOX-101 in acute intracerebral hemorrhage (ICH), including Day 360 functional outcomes, has been selected for a late-breaking oral presentation at the 18th World Stroke Congress (WSC 2026). The congress will take place at the COEX Convention & Exhibition Center in Seoul, South Korea, from October 21 to 23, 2026.
The presentation will be given by Dr. Dimitri Hemelsoet, neurologist at Ghent University Hospital, one of the centers that enrolled patients in the trial.
“BIOX-101 was safe, demonstrated rapid target engagement and showed encouraging signals of reduced secondary injury and improved recovery in our patients,” said Dr. Dimitri Hemelsoet. “These findings support advancement to a later-phase trial.”
Marc Dechamps, Chief Executive Officer of Bioxodes, said: “No treatment has ever been approved to treat intracerebral hemorrhage, which often causes serious disability or death. These new data build on the positive topline results reported earlier this year, suggesting that BIOX-101 may reduce secondary damage and support functional recovery after ICH.”
Bioxodes is preparing a Phase 2b “BIRCH 2” trial of BIOX-101 in about 200 ICH patients. The company is in discussions with potential partners and investors to finance the study.
BIRCH (NCT05970224) was a randomized (3:1), open-label Phase 2a proof-of-concept trial conducted at 8 stroke units in Belgium. It compared BIOX-101 added to standard of care against standard of care alone in 23 patients with first-ever spontaneous ICH of 5 to 60 mL. BIOX-101 was given as a 48-hour intravenous infusion started within 24 hours of symptom onset. Positive topline data were reported in May 2026 at ESOC.
Bioxodes will present the complete dataset at the World Stroke Congress on October 21 and plans to host a KOL event and investor webcast following the presentation.
Presentation details
Abstract number: 1056
Title: BIRCH: A Phase IIa randomized study of BIOX-101 in acute intracerebral hemorrhage
Session: Late Breaking Science Abstracts 02, ICH, Vascular Risk & Prevention
Date and time: Wednesday, October 21, 2026, 10:00 to 11:30 KST
Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat intracerebral hemorrhage (ICH), the deadliest and most disabling form of stroke, for which no approved therapy exists. BIOX-101’s unique dual mechanism of action has the potential to address a broad range of thromboinflammatory diseases beyond ICH. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes’ research is supported by the Walloon Region (SPW Recherche), and the company is registered in Belgium under number 825.151.779.
For further information, please contact:
| HEAD OFFICES BioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 1 6041 Gosselies, Belgium +32 496 59 03 54 investment@bioxodes.com |
MEDIA RELATIONS, BELGIUM Alexandra Schiettekatte communication@bioxodes.com +32 476 65 04 38 |
| INVESTOR RELATIONS AND INTERATIONAL MEDIA RELATIONS Giovanni Ca’ Zorzi Cohesion Bureau giovanni.cazorzi@cohesionbureau.com |
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