Bioxodes Reports Positive Phase 2a Interim Results for BIOX-101 in Stroke Patients

GOSSELIES, Belgium, April 24, 2025 — Bioxodes SA, a company specializing in biopharmaceutical innovations, has announced favorable interim results from its BIRCH Phase 2a clinical trial. This trial evaluates BIOX-101, a therapeutic candidate aimed at addressing intracerebral hemorrhagic stroke (ICH), a severe neurological condition. The interim analysis, based on data from 16 participants, confirmed both primary safety and secondary efficacy objectives were achieved. Importantly, the Data Monitoring Committee (DMC) noted no safety issues concerning changes in ICH volumes, adverse events, neurological outcomes, or mortality.

Bioxodes has concluded patient recruitment for the trial, asserting that further data collection would not considerably alter the outcome. The company anticipates a second interim report in the latter half of 2025, with final study results expected in 2026. Plans are underway to initiate a Phase 2b trial for BIOX-101, which may eventually serve as a registrational study.

Hans Warrinnier, Chief Medical Officer at Bioxodes, expressed optimism about the interim findings, emphasizing that the data aligns well with expectations. He highlighted the severe nature of hemorrhagic strokes and the urgent need for effective treatments, underscoring the company's commitment to addressing this often-overlooked condition.

Bioxodes is preparing to embark on a Series B funding round and commence the Chemistry, Manufacturing, and Controls (CMC) process required to produce sufficient BIOX-101 for upcoming trials. This preparation phase is anticipated to last approximately one year, with recruitment for the Phase 2b trial projected to begin in early 2027.

Remarkably, the trial has not recorded any fatalities, and no serious adverse events have been linked to the treatment. Patients tolerated the treatment well, with no indication of increased bleeding. Pharmacokinetic and pharmacodynamic data demonstrated consistency, and imaging data indicated favorable outcomes concerning hematoma and edema volumes. Additionally, exploratory outcomes related to inflammation biomarkers were promising.

ICH is a particularly severe form of stroke, contributing to a significant percentage of stroke-related deaths despite representing a smaller fraction of total stroke cases. The lack of approved treatments leaves many survivors with long-term disabilities. In March 2025, Bioxodes received Orphan Drug Designation for BIOX-101 in the U.S. and Europe. The company plans to file for PRIME status with the European Medicines Agency and pursue Fast Track designation from the FDA as development progresses. The upcoming Phase 2b trial might enable conditional marketing authorizations in both the U.S. and Europe before 2030.

BIOX-101 is a recombinant protein derived from the saliva of Ixodes ricinus ticks, targeting the adverse secondary effects of hemorrhagic stroke such as ischemia, neuroinflammation, and neuronal damage. Its anti-inflammatory action stems from inhibiting neutrophil activation and the release of extracellular DNA filaments, which contribute to excessive inflammation and brain damage. Unlike traditional anticoagulants, BIOX-101 mitigates clotting without amplifying bleeding risks by focusing on Factors XIa and XIIa within the intrinsic coagulation pathway. Bioxodes is also exploring the potential of BIOX-101 in treating acute ischemic stroke.

Bioxodes, a Belgium-based clinical-stage biopharmaceutical company, is at the forefront of developing innovative therapies for thrombotic and inflammatory conditions. Their lead asset, BIOX-101, represents a novel approach to combating thromboinflammatory diseases. The company, backed by various patents and the Walloon Region, continues to advance its pipeline of drug candidates aimed at addressing significant medical needs.