Bioxodes Announces Positive DMC Meeting for BIOX-101 Phase 2a Hemorrhagic Stroke Trial

Bioxodes SA, a clinical stage biopharmaceutical company based in Gosselies, Belgium, has announced that the Data Monitoring Committee (DMC) has reviewed initial data from the first eight patients enrolled in the Phase 2a clinical trial of BIOX-101. This study aims to evaluate the drug's potential in preventing secondary damage following intracerebral hemorrhagic stroke (ICH).

The ongoing Phase 2a trial, named BIRCH, is a randomized, open-label, and controlled study that plans to enroll a total of 32 patients. Treatment with BIOX-101, administered intravenously, is initiated within the first few hours after the onset of ICH. To date, no serious adverse events linked to BIOX-101 have been reported, and no patient fatalities have occurred.

ICH, which accounts for 13% of all strokes, is a dire medical condition responsible for 40% of stroke-related deaths and frequently results in permanent or long-term disability. Currently, there are no approved treatments available for patients suffering from ICH. Marc Dechamps, CEO of Bioxodes, expressed optimism over the DMC’s positive recommendation and the absence of safety issues associated with BIOX-101.

BIOX-101 is described as a first-in-class drug candidate derived from a protein found in tick saliva. According to Edmond Godfroid, PhD, the company’s co-founder and Chief Scientific Officer, tick saliva has been shown to modulate immune responses and defense mechanisms in the host. BIOX-101 exhibits potent anti-inflammatory and antithrombotic properties without increasing the risk of bleeding, making it a promising candidate for preventing secondary brain injuries in ICH patients. While the company aims to expand testing to ischemic strokes and other conditions, ICH is classified as an orphan disease in the United States and Europe, which could expedite its market availability.

Following the treatment of the initial eight patients, the company is conducting a preliminary analysis of pharmacokinetic and pharmacodynamic data to determine the dose-response and efficacy of BIOX-101. This data may be shared with select potential partners or investors under confidentiality agreements.

The DMC’s recommendation permits Bioxodes to proceed with enrolling an additional 24 patients in the study. An interim data read-out from the first 16 patients is anticipated around the end of 2024. The study is being conducted across 10 stroke units in Belgium, led by Professor Robin Lemmens, a renowned stroke specialist and head of clinic at the University Hospital Leuven. Patients enrolled in the trial are aged 18 or older, with 24 receiving BIOX-101 and 8 receiving standard-of-care treatment. The standard-of-care primarily focuses on monitoring and stabilizing the patient without the use of anticoagulant medication, which poses the risk of secondary damage.

The primary goals of the study are to assess the safety and tolerability of BIOX-101 in patients with spontaneous ICH, while also generating preliminary data on its efficacy. All patients will be monitored for at least one year to evaluate the long-term functional outcomes of the treatment.

BIOX-101 operates by inhibiting blood clot formation without increasing bleeding risk, unlike traditional anticoagulants. It also prevents acute neuroinflammatory events associated with ICH by inhibiting the activation of neutrophils, a type of white blood cell. Additionally, BIOX-101 is in the early stages of development for other indications, including ischemic stroke and various thrombo-inflammatory diseases.