Bioxodes Strengthens Clinical Advisory Board and Advances BIOX-101 Pivotal Trial for Intracerebral Hemorrhage
Key Insights
Bioxodes (search) has appointed three world-leading neurovascular experts to its Clinical Advisory Board as it prepares for a pivotal Phase 2b/3 trial of BIOX-101 for intracerebral hemorrhage (search) treatment.
The company's adaptive trial design will include up to 500 patients with functional outcomes as the primary endpoint, potentially enabling accelerated approval after positive Phase 2b interim data.
BIOX-101 targets the deadliest form of stroke (search) affecting up to 40% of stroke-related deaths, with fewer than 20% of survivors achieving functional independence after six months.
Bioxodes (search) SA has significantly expanded its Clinical Advisory Board with the appointment of three internationally respected neurovascular experts as the Belgian biopharmaceutical company prepares to launch a landmark pivotal trial for BIOX-101 in treating intracerebral hemorrhage (search) (ICH). The strategic appointments come as Bioxodes engages in ongoing discussions with regulators to finalize the design of what could become a registrational study for this urgent unmet medical need.
Expert Advisory Board Expansion
The newly appointed experts bring extensive clinical and research expertise to Bioxodes (search)' global registrational strategy. Neshika Samarasekera, PhD, joins as a consultant neurologist at NHS Lothian and NRS Research Fellow at the University of Edinburgh's Centre for Clinical Brain Sciences. Her research focuses on epidemiology, causes and long-term consequences of ICH, including neuroinflammation (search) and perihematomal edema—key endpoints in BIOX-101's upcoming Phase 2b/3 trial.
Prof. Karin Klijn, Chair of the department of Neurology at the Radboud University Medical Center in Nijmegen, Netherlands, brings recognized expertise as one of Europe's leading authorities on intracerebral hemorrhage (search). She has authored numerous peer-reviewed publications and led multiple international studies aimed at improving outcomes after brain hemorrhage.
Else Charlotte Sandset, MD, PhD, serves as Chair of Stroke (search) and General Neurology at Oslo University Hospital (search) and chairs the Oslo Clinical Stroke Research Group. As former Secretary General of the European Stroke Organisation, she contributes extensive pan-European stroke network experience to the international Phase 2b/3 program.
The expanded Clinical Advisory Board now comprises 11 world-leading stroke (search) specialists from across the globe, reflecting what CEO Marc Dechamps describes as "widespread conviction amongst the leading clinical experts in our field."
Pivotal Trial Design and Regulatory Strategy
Following a recent FDA pre-IND meeting, Bioxodes (search) concluded that a single registrational study using functional outcomes as the primary endpoint could be sufficient for both U.S. and EU marketing authorizations. The primary endpoint will be measured using the modified Ranking Scale (mRS), which provides a single score ranging from 1 to 6 reflecting a patient's level of functional independence after stroke (search).
Change in perihematomal edema (PHE), a biomarker associated with poor functional outcomes in ICH, will serve as a key secondary efficacy endpoint. This approach builds on results from Bioxodes (search)' Phase 2a trial, which suggested that BIOX-101 reduced hematoma volume and slowed PHE growth compared to the standard of care arm.
The company has developed an adaptive Phase 2b/3 study design accommodating up to 500 patients, with the Phase 2b portion requiring approximately 265 patients. Interim analysis from the Phase 2b portion will enable sample size re-estimation and provide early assessment of significance or probability of success. Bioxodes (search) is currently in discussions with the FDA and EMA to confirm that compelling Phase 2b interim efficacy data would be sufficient to support an accelerated approval pathway.
Addressing Critical Unmet Medical Need
Intracerebral hemorrhage (search) represents the deadliest form of stroke (search), a devastating condition with no approved therapy that accounts for up to 40% of all stroke-related deaths. The clinical impact is severe: fewer than 20% of survivors achieve functional independence after six months, with secondary damage from untreated bleeding and inflammation causing secondary ischemia, neuroinflammation (search) and neuronal damage.
BIOX-101 is a proprietary recombinant version of a small protein found in the saliva of the tick (Ixodes ricinus). The drug candidate is designed to inhibit the harmful secondary effects of hemorrhagic stroke (search) through a unique dual mechanism of action. Unlike currently marketed anticoagulants, BIOX-101 reduces clotting without increasing bleeding by targeting Factors XIa and XIIa of the intrinsic coagulation pathway.
The candidate also exerts anti-inflammatory effects through a second mechanism, inhibiting activation of neutrophils (search) and their release of extracellular DNA filaments (neutrophil extracellular traps, or NETs). These NETs can cause excessive inflammation, contributing to edema expansion and exacerbating brain damage while disrupting the blood-brain barrier.
Funding and Timeline
Bioxodes (search) is actively raising a Series B round of €70 million to finance the trial, manufacturing and registration processes. This target represents a reduction from a previously announced €100 million, based on costing for the new adaptive trial design and reduced investment in developing BIOX-101 for additional indications. The company has now fully focused on ICH and deprioritized additional indications.
The company intends to seek U.S. Fast Track and EU PRIME designations and estimates that BIOX-101 could receive U.S. approval in late 2030, with EU approval following in 2031. Active discussions are ongoing with strategic partners and potential investors as the company advances toward this pivotal trial initiation.
Dechamps emphasized that "guidance from these experts, along with our ongoing dialogue with regulators in U.S. and EU, will be central to our trial design and execution, and highly relevant to our advanced fundraising and partnering discussions."