Bioxodes SA announced positive interim results from its Phase 2a BIRCH trial of BIOX-101 for intracerebral hemorrhagic stroke (ICH). The trial met its primary safety and secondary efficacy endpoints in the first 16 patients, with no drug-related serious adverse events observed. Based on these promising findings, Bioxodes halted recruitment early and is preparing for a Phase 2b trial.
This development is potentially groundbreaking for the ICH field, as there are currently no approved treatments. The positive safety and efficacy signals, coupled with the orphan drug designation already granted in the US and Europe, suggest BIOX-101 could address a significant unmet medical need and substantially improve patient outcomes for this often-fatal and debilitating condition. The decision to move directly to a potentially registrational Phase 2b trial indicates a high level of confidence in the therapy’s potential.
The interim analysis revealed no deaths or treatment-related serious adverse events. The drug was well-tolerated, showed consistent exposure during infusion, and demonstrated positive effects on hematoma and edema volumes. Furthermore, encouraging exploratory outcomes were observed on inflammation biomarkers. Bioxodes plans to release a second interim report later in 2025 and a final analysis in 2026. The company is initiating a Series B funding round to support the manufacturing process for BIOX-101 needed for the Phase 2b trial, anticipated to begin recruitment in the first half of 2027.
This positive interim data positions BIOX-101 as a potential game-changer in the treatment of ICH. If the Phase 2b trial confirms these findings, BIOX-101 could become the first approved therapy for this devastating condition, offering hope for patients and potentially transforming the standard of care. The accelerated timeline towards a potentially registrational trial, coupled with the pursuit of PRIME and Fast Track designations, suggests that Bioxodes aims to bring this much-needed therapy to market as quickly as possible.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
