Bioxodes SA, a biopharmaceutical company focused on developing therapies for thrombotic and inflammatory diseases, has secured €2.7 million in an extension of its Series A funding round. This investment will support the advancement of BIOX-101, a first-in-class drug candidate for the treatment of intracerebral hemorrhage (ICH). The company is currently conducting the BIRCH Phase 2a trial and preparing for a Phase 2b trial, with the goal of addressing the high unmet medical need in ICH, an orphan disease with no approved therapeutic interventions.
BIOX-101: A Novel Approach to ICH Treatment
BIOX-101 is derived from a small protein found in tick saliva and is designed to mitigate secondary brain injuries following a hemorrhagic stroke. Unlike existing anticoagulants, BIOX-101 reduces clot formation without increasing the risk of bleeding. Preclinical studies have demonstrated that BIOX-101 prevents blood clot formation and reduces neuroinflammation after ICH. The drug also inhibits the activation of neutrophils and the release of extracellular DNA filaments (NETs), which contribute to excessive inflammation and disruption of the blood-brain barrier.
BIRCH Phase 2a Trial and Upcoming Milestones
The ongoing BIRCH trial is a randomized, open-label study evaluating BIOX-101 in ICH patients. Bioxodes has completed enrollment of the first 16 patients and is continuing recruitment to reach a total of 32 patients. Interim data from the first cohort are expected in Q1 2025. According to Marc Dechamps, CEO of Bioxodes, the company anticipates a response from U.S. and EU regulators regarding its application for Orphan Drug Designation for BIOX-101 in the first quarter of 2025. The company is also preparing to ramp up production of BIOX-101 for a potential registrational international Phase 2b trial, with recruitment expected to begin in Q1 2027.
Addressing a Critical Unmet Need in Stroke Care
ICH accounts for approximately 13% of all strokes but contributes to 40% of stroke-related deaths, often leaving survivors with significant disabilities. Current standard of care primarily involves monitoring and stabilizing patients, with limited therapeutic options available. BIOX-101 represents a potential breakthrough by targeting the underlying mechanisms of secondary brain injury in ICH.
Series B Funding and Future Development
Bioxodes is planning to launch a Series B funding round of approximately €50 million in Q2 2025. These funds will support the Chemistry, Manufacturing, and Controls (CMC) activities required for BIOX-101 production, as well as clinical development for ICH and other potential indications, including ischemic stroke and other thrombo-inflammatory diseases. The company also intends to explore additional novel options for treating thrombotic and inflammatory conditions.
