Bioxodes SA has announced the final results of its Phase 2a BIRCH trial for BIOX-101, an investigational therapy targeting intracerebral hemorrhage (ICH), a condition currently lacking approved treatments. The trial, which included 23 patients, demonstrated that BIOX-101 met its primary safety endpoint and indicated promising efficacy signals across secondary measures. This builds on positive interim findings released in September 2025, reinforcing the company’s confidence in advancing BIOX-101 through further clinical development.

The significance of these results lies in BIOX-101’s dual mechanism of action. It inhibits Factors XIa and XIIa in the intrinsic coagulation pathway, reducing clotting without increasing bleeding risks, a critical advancement over existing anticoagulants. Additionally, it exerts anti-inflammatory effects by inhibiting neutrophil activation and the release of neutrophil extracellular traps (NETs), which contribute to secondary ischemia and edema expansion. These mechanisms are particularly relevant given that ICH is associated with high morbidity and mortality, and the ability to mitigate secondary damage could enhance functional outcomes for patients.

The upcoming pivotal Phase 2b/3 trial, which aims to enroll up to 500 patients, will focus on functional outcomes as the primary endpoint, with changes in perihematomal edema (PHE) as a key secondary measure. This shift towards functional endpoints could redefine clinical success criteria in stroke treatment and potentially accelerate drug development timelines. Bioxodes is currently raising €70 million to support this trial and is in discussions with regulatory bodies to explore accelerated approval pathways, with expectations for U.S. approval by late 2030 and in the EU by 2031.

Source: globenewswire.com