Bioxodes Advances Promising Stroke Treatment with Successful Phase 2a Trial

Belgian biotech company Bioxodes has made significant strides in the development of a potential breakthrough treatment for intracerebral hemorrhagic stroke (ICH). The company's innovative drug, BIOX-101, also known as Ir-CPI, has shown promising results in a recent phase 2a clinical trial, paving the way for a potentially registrational study.

Interim Analysis Yields Positive Results

Bioxodes has halted enrollment in its phase 2a stroke study following a successful interim review. The analysis, which included data from 16 ICH patients, demonstrated that BIOX-101 met both safety and efficacy endpoints. Patients received either a single intravenous dose of BIOX-101 in addition to standard care or standard care alone.

Key findings from the interim analysis include:

• Positive changes in hematoma and edema volume, a secondary efficacy endpoint
• Encouraging inflammation biomarker results
• No patient deaths
• No serious adverse events attributed to the drug
• Well-tolerated treatment with no signs of increased bleeding

Hans Warrinnier, Chief Medical Officer at Bioxodes, stated, "The results are preliminary but all point in the right direction." The company believes that generating additional phase 2a data would not alter the interim conclusions, leading to the decision to halt enrollment early.

Unique Mechanism of Action

BIOX-101 is derived from a protein found in tick salivary glands, which naturally prevents blood clotting to allow the tick to feed. Repurposed for ICH treatment, this approach could potentially address blood clots without causing bleeding complications.

The development of BIOX-101 is particularly significant given the current lack of approved treatments for ICH. While other efforts are underway, such as a phase 3 study of recombinant factor VIIa (rFVIIa), previous attempts have faced setbacks. An earlier phase 3 trial of rFVIIa failed to improve survival or functional outcomes, highlighting the challenges in this therapeutic area.

Looking Ahead: Series B Financing and Phase 2b Trial

Following these encouraging results, Bioxodes is now preparing for the next stages of development. The company plans to:

1. Initiate a Series B financing round
2. Prepare BIOX-101 for a phase 2b trial

Marc Dechamps, CEO of Bioxodes, anticipates that this process will take approximately one year. The company aims to begin enrolling patients in the potentially pivotal phase 2b study in the first half of 2027. Bioxodes is optimistic that this phase 2b trial could support filings for conditional marketing authorization in both the United States and Europe before 2030.

As the pharmaceutical industry continues to search for effective treatments for ICH, Bioxodes' progress with BIOX-101 represents a promising development in addressing this critical unmet medical need.