Bioxodes meets first Phase 2a patient enrollment milestone with BIOX-101 in intracerebral hemorrhagic stroke
27 June 2024 - 7:30AM
First-in-class drug candidate
evaluated in first eight patients
Gosselies (Belgium), June 27,
2024 – Bioxodes SA, a clinical
stage biopharmaceutical company developing novel therapies for the
prevention and treatment of thrombotic and inflammatory diseases,
announces today that it has enrolled the first eight of 32 patients
in a Phase 2a clinical study of its lead asset BIOX-101 (Ir-CPI).
The study is evaluating BIOX-101 in intracerebral hemorrhagic
stroke (ICH), a devastating condition for which there is currently
no available treatment. Reaching this first milestone allows
Bioxodes to conduct an initial analysis of pharmacokinetic and
pharmacodynamic data to evaluate the dose-response and preliminary
clinical proof-of concept of the therapeutic candidate, as well as
safety in this patient population.
“For the first time, we are able to assess the
preliminary results of BIOX-101 in ICH patients, who up until now
have had very few treatment options. Analysis of these first 8
patients will yield preliminary proof-of-concept data for BIOX-101,
a first-in-class drug candidate derived from a protein found
in the saliva of the tick 1, designed to prevent the harmful
secondary brain injuries that occur after a hemorrhagic stroke,”
said Marc Dechamps, Chief Executive Officer at Bioxodes.
The study, conducted in 10 stroke units in
Belgium and led by Prof Robin Lemmens, a world-leading stroke
authority and head of the clinic at the University Hospital Leuven,
aims to enroll 32 patients aged 18 and above, with 24 receiving
BIOX-101, and 8 standard-of-care treatment. The trial is a
randomized, open-label proof-of-concept study, and will evaluate
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 one year to evaluate the impact of the treatment on
long-term functional outcomes. Interim results for the first 16
patients are expected by the fourth quarter of 2024.
BIOX-101 prevents blood clot formation without
increasing the risk of further bleeding. Moreover, by inhibiting
the activation of neutrophils, a type of white blood cell that
often act as the first responders of the inflammatory system, it
also prevents the acute neuroinflammatory events associated with
ICH. BIOX-101 is also in early development as a platform for a
series of other indications, including ischemic stroke and other
thrombo-inflammatory diseases.
KEY FACTS ABOUT STROKE:* 15 million people
worldwide suffer from a stroke each year, * Of those, 5
million die, another 5 million are left severely disabled* Stroke
is the leading cause of disability among neurological conditions
worldwide, according to the Global Burden of Disease Study 2021
(Lancet Neurology May 2024).* Two types: ischemic stroke (caused by
a blood clot) and hemorrhagic stroke (ruptured vessel)* Hemorrhagic
stroke makes up 13% of all cases, but causes 40% of deaths*
Intracerebral hemorrhagic stroke (ICH) is by far the most common
type of hemorrhagic stroke * For hemorrhagic stroke, there is
little other to do than surgery, with poor outcomes* Bioxodes has
applied for an orphan disease designation for BIOX-101 in the US
and EU. Being awarded the designation could accelerate the
regulatory approval process.
1 Ixodes ricinus
About Bioxodes Bioxodes is
a clinical stage biopharmaceutical company developing novel
therapies for the prevention and treatment of thrombotic and
inflammatory diseases. Since its founding in 2013, Bioxodes has
developed its lead asset BIOX-101, a first-in-class drug candidate
aimed at patients with thrombo-inflammatory disease. BIOX-101’s
unique mechanism of action is the foundation of an innovative
pipeline of drug candidates for the prevention of
(thrombo)inflammatory diseases. The company, which is based in the
biopark of Gosselies near Brussels in Belgium, has so far secured
€34 million in funding from Belgian investment funds and business
angels, including €12 million in non-dilutive funding from the
Wallonia region. Worldwide, Bioxodes holds both granted and pending
patents associated with BIOX-101. http://www.bioxodes.com/
For more information please
contact:
HEAD OFFICESBioPark Charleroi-Bruxelles SudRue
Santos-Dumont, 16041 Gosselies, Belgium+32 496
590354investment@bioxodes.com |
MEDIA RELATIONSAlexandra
Schiettekatte alexandra.alicato@outlook.com+32 476 65
04 38 COHESION BUREAUEU MEDIA
RELATIONSSophie Baumontsophie.baumont@cohesionbureau.com INVESTOR
RELATIONSGiovanni Ca’ Zorzigiovanni.cazorzi@cohesionbureau.com |
|
- 20240627 Bioxodes PR first 8 patients (final) EN