Successful clinical outcomes for drug treating rare stroke condition
Ella Day | April 25, 2025 | News story | Research and Development | Bioxodes, Neurology, clinical trial, stroke
Flemish biopharma company, Bioxodes, has announced promising results from the BIRCH phase 2a clinical trial of BIOX-101 to treat intracerebral haemorrhagic stroke (ICH). This brings the company closer to rolling out the first approved treatment for the devastating condition.
The BIRCH trial, which took place with 16 patients with ICH, met both primary safety and secondary efficacy endpoints. No safety concerns were identified either. The product, BIOX-101, is designed to inhibit harmful secondary effects of haemorrhagic strokes including neuroinflammation and neuronal damage. It is a leading product in Bioxodes’s mission to develop therapies for thrombotic and inflammatory diseases.
With these promising results, Bioxides will release a second interim report later this year and a phase 2b trial of BIOX-101, anticipated to start in early 2027. If the subsequent trial is sufficient, the asset could be granted conditional marketing authorisations in the US and Europe before the end of the decade.
Bioxides’ CEO, Marc Dechamps, stated: “These encouraging results are an important milestone which enables us to start looking ahead.”
There is an acute need for ICH treatment as although it only accounts for 13% of all stroke cases, it makes up 40% of all stroke-related deaths. Moreover, survivors are often left with permanent or long-term disability. There is currently no approved treatment and Bioxides hopes to change this.
Hans Warrinnier, chief medical officer of the company, added: “Although haemorrhagic stroke often has debilitating consequences, it is a neglected disease and the prospect of offering these patients hope is a strong motivating factor for our team.”
Ella Day
25/4/25
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