On World Stroke Day (29 October), Bioxodes told Clinical Trials Arena that it will soon begin a pivotal trial on its lead haemorrhagic stroke candidate, BIOX-101.
Bioxodes CEO Marc Dechamps noted that the company is currently looking into whether it should progress BIOX-101 into a Phase IIb or Phase III, following its successful Phase IIa trial; however, this will depend on the verdict offered by regulatory authorities.
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Regardless of this, Bioxodes will initiate a pivotal trial involving the drug, which “may lead to conditional marketing approval”.
The company is also putting in an application for BIOX-101 through the European Medicines Agency’s (EMA’s) Priority Medicines (PRIME) scheme, which is expected to be submitted around the end of Q1 or the beginning of Q2 2026.
Alongside its collaboration with the EMA, Bioxodes is planning a pre-meeting with the US Food and Drug Administration (FDA), which is set to occur at the beginning of January 2026.
This meeting will be used to determine what the FDA requires for a pivotal trial, as there is currently no standard protocol for intracerebral haemorrhage. To achieve this, Dechamps noted that the company will work with both experts and biostatistical specialists.
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By GlobalDataIf all goes to plan, Dechamps stated that Bioxodes could be positioned to recruit patients for this trial by the end of Q1 2027. It will involve 30 centres in total, with 15 across the US and Canada, and 15 in Europe.
While these locations are priority regions for Bioxodes, the company also hopes to bring the drug to China, as there are between 800,000 and one million cases of haemorrhagic stroke within the country a year.
Phase IIa data promising
This follows a second interim readout of the Phase IIa BIRCH trial (NCT05970224), debuted by Bioxodes in September 2025, finding that the recombinant protein trended towards slowing perihaematomal oedema expansion over a ten-day period post-stroke.
Patients given BIOX-101 also appeared to experience a decrease in haemorrhage volume after ten days. Meanwhile, neutrophil-to-lymphocyte ratios showed favourable trends compared with standard of care (SoC), which currently relies on surgery and the use of antihypertensive agents.
Recovery signals observed in the BIOX-101 cohort also seemed more favourable than patients given SoC treatment, with more in the former group regaining functional independence by day 90. This was measured by a modified Rankin scale (mRS) score of between 0 and 2.
The trial enrolled 23 patients across ten locations in Belgium.
Fulfilling unmet needs in haemorrhagic stroke
While SoC treatments offer patients some hope, Dechamps noted that these interventions cannot prevent secondary damages caused by a haemorrhagic stroke.
He said: “Currently, physicians can only stabilise a patient or decrease their blood pressure if it is too high, as there are no approved targeted therapies for the treatment of haemorrhagic stroke.”
Since there is a lack of pharmacological options available for this patient population, Bioxodes wanted to develop a drug that could help improve outcomes and reduce the burden of haemorrhagic stroke on patients.
Dechamps said: “BIOX-101 is a dual-functioning therapy, as it can both prevent the mobilisation, infiltration and activation of neutrophils and block the coagulation cascade without generating further bleeding.”
This means that, if approved, BIOX-101 could prevent secondary damages associated with intracranial bleeding and the inflammatory response, which no other drug has managed to achieve to date.
“This is a field where there are no drugs to displace, with no competitors and no specific medical interventions except surgery for severe cases,” Dechamps commented.
Bioxodes obtained orphan drug designations from the FDA and the EMA for BIOX-101 in haemorrhagic stroke in February and March, respectively.
BIOX-101’s potential in ischemic stroke
Though BIOX-101 was traditionally developed for use in haemorrhagic stroke, Bioxodes is now looking to explore its potential in the ischemic subset of stroke patients.
This is because around 50% of patients undergoing thrombectomy experience reperfusion, even after thrombolysis.
Dechamps added: “This treatment may trigger the creation of a secondary brain ischemia, which can block blood flow in the brain. This is the same mechanism that occurs in intracellular haemorrhage.”
This means that BIOX-101’s use could extend to ischemic stroke, as it could be used by physicians performing a thrombectomy to improve patient outcomes.
According to Dechamps, a trial in ischemic stroke could well occur “in the near future,” where the company would likely go directly to Phase II “somewhere in 2028”.
