Bioxodes SA has appointed Philippe Monteyne, MD, PhD, as chairman of its Board of Directors as the Belgian clinical-stage biopharmaceutical company accelerates development of its breakthrough stroke candidate BIOX-101. The appointment comes as Bioxodes prepares for a potentially registrational Phase 2b trial that could support conditional marketing authorization submissions in the U.S. and Europe.
Dr. Monteyne brings extensive pharmaceutical industry experience, having held senior positions at SmithKline Beecham, GSK, and Sanofi. At GSK, he led the development and launch of cervical cancer vaccine Cervarix® and oversaw research enabling development of Strimvelis®, an autologous gene therapy for ADA-SCID, and Tegsedi®, an oligonucleotide for hATTR. He currently serves as Senior Advisor for Life Sciences at AltamarCAM Partners, which manages over 20.8 billion euros in private market investments.
Promising Phase 2a Results Drive Leadership Expansion
The leadership appointment follows encouraging second interim results from Bioxodes' BIRCH Phase 2a clinical trial announced in September. All patients treated with BIOX-101 experienced hematoma reduction, supported by biomarker measurements that trended favorably with clinical observations. Functional outcomes showed signals of recovery more favorable than the standard-of-care control group, with more patients regaining independence on day 90 after BIOX-101 treatment compared to the control group.
"His experience and track record in developing new therapies in areas of high unmet medical need will lend invaluable guidance to the company just as new data have confirmed the breakthrough potential of BIOX-101 in treating stroke," said Marc Dechamps, Chief Executive Officer of Bioxodes. The company aims for commercialization potentially as early as 2030.
Addressing Critical Unmet Need in Hemorrhagic Stroke
Intracerebral hemorrhage (ICH) represents a devastating condition with no approved therapies, accounting for 40% of all stroke-related deaths despite comprising just 15% of stroke cases. Mortality approaches 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 due to secondary damage from untreatable bleeding and associated inflammation.
"Hemorrhagic stroke is an unmet medical need and one of the most pressing unresolved neurological problems science is facing," said Dr. Monteyne. "With no approved therapies for hemorrhagic stroke available today, BIOX-101 promises a unique opportunity to help shape an entirely new market by arming physicians with a drug that may significantly reduce mortality and improve outcomes for this lethal disease."
Novel Mechanism Targets Multiple Pathways
BIOX-101 is a proprietary recombinant version of a small protein found in tick (Ixodes ricinus) saliva, designed to inhibit harmful secondary effects of hemorrhagic stroke including secondary ischemia, neuroinflammation, and neuronal damage. Unlike currently marketed anticoagulants, BIOX-101 reduces clotting without increasing bleeding by targeting Factors XIa and XIIa of the intrinsic coagulation pathway.
The investigational therapy also exerts anti-inflammatory effects by inhibiting neutrophil activation and their release of extracellular DNA filaments (NETs), which can cause excessive inflammation, exacerbate brain damage, and disrupt the blood-brain barrier. Beyond ICH, Bioxodes plans to develop BIOX-101 for acute ischemic stroke and an undisclosed indication.
Regulatory Pathway and Timeline
The upcoming Phase 2b trial, scheduled to begin in 2027, represents a potentially registrational study that could be sufficient for conditional marketing authorization submissions in both the U.S. and Europe if successful. This accelerated pathway reflects the significant unmet medical need in hemorrhagic stroke treatment.
Bioxodes holds both granted and pending patents worldwide associated with BIOX-101, and the company's research receives support from the Walloon Region (SPW Recherche). The appointment of Dr. Monteyne strengthens the company's leadership as it advances this first-in-class drug candidate through late-stage clinical development toward potential market entry.
