Bioxodes to present final Phase 2a trial results confirming breakthrough potential of BIOX-101 for intracerebral hemorrhage in poster at ESOC 2026

• Final results of BIRCH multicenter, randomized, open-label Phase 2a proof-of-concept BIRCH trial with 23 patients, conducted in Belgium
• Final results build on positive second interim results announced in September 2025
• Bioxodes is raising €70 million Series B to finance pivotal adaptive Phase 2b/3 trial, with functional outcomes as primary endpoint
• BIOX-101 could be granted U.S. approval by late-2030; 2031 in EU.

Gosselies, Belgium, 28 APRIL 2026 (08:30 CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, will present the final results of its Phase 2a trial of its investigational therapy, BIOX-101, for intracerebral hemorrhage (ICH) in a poster presentation at the European Stroke Organisation Conference (ESOC) 2026 in May.

The final BIRCH results build on the positive second interim results announced on September 2025, when Bioxodes reported that BIOX-101 met its primary safety endpoint and showed encouraging signals of efficacy across all exploratory secondary measures.

“Presenting the final data to the scientific community at such a prestigious venue as ESOC strengthens us in our belief that we are on the right track with BIOX-101, as we continue to book progress both from a regulatory and clinical point of view,” said Marc Dechamps, Chief Executive Officer of Bioxodes. “Intracerebral hemorrhage is a devastating disease for which no approved treatment exists, something we are aiming to change by bringing BIOX-101 to market by the end of 2030.”

Details of the poster presentation are as follows:

Abstract number: ESOC2026LB16
Abstract title: BIRCH: A Phase IIa proof-of-concept study of BIOX-101 in spontaneous intracerebral haemorrhage
Poster No.: P143
Paper poster presentation: Wednesday, 6 May 13:00-14:00 CEST
Location: Poster area
Topic / Subtopic: 02.00 Intracranial hemorrhage, 02.01 Intracerebral hemorrhage

Bioxodes is planning a pivotal adaptive Phase 2b/3 trial with up to 500 patients with functional outcomes as primary endpoint ¹. Change in perihematomal edema (PHE), a biomarker associated with poor functional outcomes in ICH ², will serve as a key secondary efficacy endpoint, following results from Bioxodes’ Phase 2a trial suggesting that BIOX-101 reduced hematoma volume and slowed PHE growth compared to standard of care.

Bioxodes previously announced it is actively engaged in a €70 million Series B fundraising to finance the trial, manufacturing, and registration. It is currently conducting discussions with the FDA and EMA to confirm Bioxodes’ view that compelling Phase 2b interim efficacy data would be sufficient to support an accelerated approval pathway. Bioxodes estimates that BIOX-101 could be granted U.S. approval in late 2030, and 2031 in the EU.

BIOX-101 is a proprietary recombinant version of a small protein found in the saliva of the tick (Ixodes ricinus). It is designed to inhibit the harmful secondary effects of hemorrhagic stroke such as secondary ischemia, neuroinflammation and neuronal damage. Unlike currently marketed anticoagulants, BIOX-101 reduces clotting without increasing bleeding. It does this by targeting Factors XIa and XIIa of the intrinsic coagulation pathway. The candidate product also exerts anti-inflammatory effects through a second mechanism, inhibiting activation of neutrophils and their release of extracellular DNA filaments (also called neutrophil extracellular traps, or NETs), which can cause excessive inflammation, contributing to edema expansion and exacerbating brain damage and disrupting the blood-brain barrier. Bioxodes reported positive BIOX-101 Phase 2a clinical proof of concept data in ICH patients and is currently preparing to initiate a Phase 2b/3 adaptive trial in ICH.

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.

¹ As measured by the modified Ranking Scale, or mRS, which gives a single score ranging from 1 to 6 reflecting a patient’s level of functional independence after a stroke.
² Peer-reviewed analysis in press, authors include members of Bioxodes’ Clinical Advisory Board.

Attachment

• 20260428 Bioxodes PR ESOC poster (final)

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