Bioxodes has stopped enrolling people in a phase 2a stroke study after hitting the safety and efficacy endpoints, positioning the Belgian biotech to power into a potentially registrational trial.
The interim phase 2a analysis included data on 16 intracerebral hemorrhagic stroke (ICH) patients. Some patients received a single intravenous dose of BIOX-101, also known as Ir-CPI, on top of standard of care. Other people only received standard of care. Bioxodes’ primary endpoints looked at safety outcomes. The biotech’s secondary endpoints assessed efficacy in the 10 days after randomization.
At the interim analysis, the biotech saw positive changes in hematoma and edema volume, a secondary efficacy endpoint, and said inflammation biomarkers were encouraging. No patients died, and no serious adverse events were attributed to the drug. The treatment was well tolerated with no signs of increased bleeding.
Hans Warrinnier, chief medical officer at Bioxodes, said in a statement that the results are preliminary but all point in the right direction. The biotech believes generating more phase 2a data won’t change the interim conclusions, leading it to stop enrollment in the study early.
Bioxodes will now start raising a series B financing round and making BIOX-101 ready for a phase 2b trial. The process will take around one year, Bioxodes CEO Marc Dechamps said, putting the company on track to start enrolling patients in the potentially pivotal study in the first half of 2027. Bioxodes said the phase 2b could support filings for conditional marketing authorization in the U.S. and Europe before 2030.
BIOX-101 is derived from a protein found in the salivary glands of a tick. The tick secretes the protein to stop the host’s blood from clotting and allow it to feed. Repurposed for treating ICH, the approach could tackle blood clots without causing bleeding.
There are currently no approved treatments for ICH. Efforts to change that include a phase 3 study of recombinant factor VIIa (rFVIIa) that has an estimated complete date of January 2028. An earlier phase 3 trial found rFVIIa failed to improve survival or functional outcomes. That trial allowed patients to receive rFVIIa up to four hours after stroke onset. The ongoing rFVIIa trial has a treatment window of two hours.