Bioxodes has made significant advancements by expanding its Clinical Advisory Board, welcoming experts from prestigious institutions. This board now includes Neshika Samarasekera from the University of Edinburgh, Karin Klijn from Radboud University Medical Center, and Else Charlotte Sandset from Oslo University Hospital. With this expansion, the board consists of 11 leading stroke specialists worldwide.
Expertise in Hemorrhagic Stroke
Marc Dechamps, the CEO of Bioxodes, emphasized the importance of this diverse expertise in preparing for a pivotal trial of BIOX-101 aimed at treating hemorrhagic stroke. The collective knowledge spans various disciplines, including epidemiology, trial design, acute care, and regulatory science. This breadth of expertise is expected to play a crucial role in fine-tuning the trial’s design and execution, enhancing the company’s fundraising and partnership efforts as it targets patient access by late 2030 in the U.S. and 2031 in the EU.
Trial Design Insights
Recent discussions with the FDA have led Bioxodes to propose that a single registrational study, focusing on functional outcomes as the primary endpoint, may suffice for marketing authorizations in both the U.S. and EU. A critical secondary efficacy endpoint will be the change in perihematomal edema (PHE), a biomarker linked to poor functional outcomes in intracerebral hemorrhage. Previous Phase 2a trial results indicated that BIOX-101 effectively reduced hematoma volume and slowed PHE growth compared to standard care.
Adaptive Study Structure
Bioxodes has designed an adaptive Phase 2b/3 study involving up to 500 patients, with approximately 265 required for the Phase 2b segment. The interim analysis will allow for sample size adjustments and early assessments of significance, aiding in the trial’s success. The company is currently engaging with both the FDA and EMA to solidify its belief that compelling Phase 2b interim efficacy data could support an expedited approval pathway.
Future Designations and Financial Plans
The company plans to apply for U.S. Fast Track and EU PRIME designations for BIOX-101, forecasting U.S. approval by late 2030 and EU approval by 2031. To facilitate the trial, manufacturing, and registration processes, Bioxodes is actively pursuing a Series B funding round of approximately €70 million. This amount has been adjusted from an earlier target of €100 million, reflecting a revised budget due to the new trial design and reduced investments in other indications.
Profiles of New Advisory Board Members
Neshika Samarasekera, PhD, joins as a consultant neurologist and research fellow at the University of Edinburgh, where she focuses on the epidemiology and long-term consequences of ICH, particularly neuroinflammation and PHE, both of which are key endpoints in BIOX-101’s upcoming trial.
Professor Karin Klijn, chair of the Neurology department at Radboud University Medical Center, is recognized for her expertise in neurovascular diseases, particularly ICH. Her extensive research and leadership in international studies aimed at improving outcomes after brain hemorrhage will significantly enhance Bioxodes’ clinical trial design.
Else Charlotte Sandset, MD, PhD, serves as chair of Stroke and General Neurology at Oslo University Hospital. Her work emphasizes acute stroke care and blood pressure management, alongside her contributions to international clinical trials. Her experience as a former Secretary General of the European Stroke Organisation adds valuable insights to Bioxodes’ international initiatives.
The Challenge of Intracerebral Hemorrhage
Intracerebral hemorrhage is a severe stroke type that lacks approved therapies and is responsible for up to 40% of stroke-related fatalities. Less than 20% of survivors achieve functional independence after six months due to secondary complications like ischemia and neuroinflammation, which can lead to further neuronal damage.
Innovative Approach of BIOX-101
BIOX-101 is a proprietary recombinant protein derived from the saliva of the Ixodes ricinus tick, designed to mitigate the damaging secondary effects of hemorrhagic stroke. Unlike existing anticoagulants, it reduces clotting without increasing bleeding risk by targeting Factors XIa and XIIa in the intrinsic coagulation pathway. It also possesses anti-inflammatory properties, inhibiting neutrophil activation and the release of extracellular DNA filaments that contribute to inflammation and brain damage.
Bioxodes has reported encouraging Phase 2a clinical proof-of-concept data for BIOX-101 in patients with ICH and is gearing up to launch a Phase 2b/3 adaptive trial for ICH, alongside Phase 2 trials for acute ischemic stroke and another undisclosed indication.
Conclusion
Bioxodes is poised for a transformative journey in treating intracerebral hemorrhage with the expansion of its Clinical Advisory Board and the innovative trial design for BIOX-101. As the company navigates regulatory pathways and advances its clinical programs, it stands to make a significant impact on stroke treatment and patient outcomes.
- Key Takeaways:
- Bioxodes expands its Clinical Advisory Board with leading stroke specialists.
- A pivotal trial for BIOX-101 is set to begin, focusing on functional outcomes.
- The adaptive study design allows for flexibility and early interim analysis.
- The company aims for expedited regulatory designations to accelerate approval.
- BIOX-101 offers a novel approach to managing hemorrhagic stroke complications.
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