Bioxodes Hits Phase 2a Enrollment Milestone with BIOX-101 in Hemorrhagic Stroke

Bioxodes SA, a clinical-stage biopharmaceutical company based in Gosselies, Belgium, has announced the enrollment of the first eight patients in a Phase 2a clinical study of its leading asset, BIOX-101 (Ir-CPI). This study focuses on intracerebral hemorrhagic stroke (ICH), a severe condition that currently lacks effective treatment options. This milestone allows Bioxodes to perform an initial analysis of pharmacokinetic and pharmacodynamic data to assess the dose-response and preliminary proof-of-concept for BIOX-101, as well as its safety profile in this patient group.

Marc Dechamps, Chief Executive Officer at Bioxodes, highlighted the significance of this development. "For the first time, we can evaluate the preliminary outcomes of BIOX-101 in ICH patients, who have had very limited treatment choices up to now. The analysis of these initial eight patients will provide early proof-of-concept data for BIOX-101, a pioneering drug candidate derived from a protein found in tick saliva, aimed at preventing the harmful secondary brain injuries that follow a hemorrhagic stroke,” he stated.

The study is being conducted across 10 stroke units in Belgium under the leadership of Professor Robin Lemmens, a renowned stroke expert and head of the clinic at the University Hospital Leuven. It aims to enroll a total of 32 patients aged 18 and above. Of these, 24 patients will receive BIOX-101, while the remaining eight will undergo standard-of-care treatment. This randomized, open-label proof-of-concept trial will assess the safety and tolerability of BIOX-101 in patients with spontaneous ICH, while also generating preliminary data on secondary efficacy objectives. All patients will be monitored for at least a year to evaluate the long-term functional outcomes of the treatment. Interim results for the first 16 patients are anticipated by the fourth quarter of 2024.

One of the key benefits of BIOX-101 is its ability to prevent blood clot formation without increasing the risk of additional bleeding. Moreover, it inhibits the activation of neutrophils, a type of white blood cell that often acts as the first responder of the inflammatory system, thereby preventing acute neuroinflammatory events associated with ICH. BIOX-101 is also in early development as a platform for various other indications, including ischemic stroke and other thrombo-inflammatory diseases.

Key facts about stroke underline the importance of this research. Annually, 15 million people globally suffer from a stroke, with 5 million fatalities and another 5 million cases resulting in severe disability. Stroke holds the position as the leading cause of disability among neurological conditions worldwide, according to the Global Burden of Disease Study 2021 (Lancet Neurology May 2024). There are two main types of stroke: ischemic stroke, caused by a blood clot, and hemorrhagic stroke, resulting from a ruptured vessel. Hemorrhagic stroke accounts for 13% of all stroke cases but is responsible for 40% of stroke-related deaths. Intracerebral hemorrhagic stroke (ICH) is the most common type of hemorrhagic stroke, and currently, the treatment options are limited primarily to surgery, which often has poor outcomes.

Bioxodes has applied for an orphan disease designation for BIOX-101 in both the US and EU. Receiving this designation could potentially expedite the regulatory approval process.

Bioxodes SA, founded in 2013, specializes in developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company's lead product, BIOX-101, is a first-in-class drug candidate targeting thrombo-inflammatory disease patients. The unique mechanism of action of BIOX-101 forms the basis for an innovative pipeline of drug candidates aimed at preventing thrombo-inflammatory diseases. Based in the biopark of Gosselies near Brussels, Belgium, Bioxodes has raised €34 million in funding from Belgian investment funds and business angels, including €12 million in non-dilutive funding from the Wallonia region. The company holds both granted and pending patents for BIOX-101 worldwide.