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Clinical trials

  • BIOX-101

    The Phase 2a BIRCH trial evaluated the safety, tolerability and potential efficacy of BIOX-101 (Ir-CPI) in adult patients with spontaneous intracerebral hemorrhage (ICH).

    • ClinicalTrials.gov Trial Identifier NCT05970224
    • Recruitment status Completed
    • Official Title A Phase IIa, Randomized, Open-label, Proof-of-Concept Study to Evaluate Safety, Tolerability and Efficacy of Ir-CPI in Patients With Spontaneous Intracerebral Haemorrhage
    • Completion Date March, 2026
    • Study Start Date July 27, 2023
    • Acronym BIRCH

    The BIRCH study was a randomized, open-label, multicentre, proof-of-concept Phase 2a trial evaluating BIOX-101 in addition to standard of care versus standard of care alone.

    The study has been completed. BIOX-101 was safe and well tolerated in patients with spontaneous ICH. Initial efficacy findings support further clinical investigation of BIOX-101 as a potential therapeutic intervention for ICH.

    Further clinical development of BIOX-101 in intracerebral hemorrhage is planned.

  • BIOX-101

    This First-In-Human (Phase 1) study was a double blind, placebo controlled, single ascending dose trial performed in healthy adult male volunteers with BIOX-101.

    • ClinicalTrials.gov Trial Identifier NCT04653766
    • Recruitment Status Completed
    • Primary Completion Date July 18, 2020
    • Study Completion Date January 4, 2023
    • Study Start Date September 12, 2019
    • The primary objectives of the study were to evaluate the safety and tolerability of BIOX-101.
    • Secondary study objectives included pharmacokinetic (PK) and pharmacodynamic (PD) assessment of BIOX-101, i.e. the effect on prolongation of the aPTT coagulation parameter and on the inhibition of FXIa and FXIIa activity.
    • Thirty-two (32) healthy adult male volunteers were enrolled in this trial with a ratio 6-active and 2-placebo per dose level.
    • A total of 4 dose levels of BIOX-101 ranging from 1.5 mg/kg up to 9 mg/kg were tested and administered intravenously for a 6-h period of infusion.

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

BIOX-101 has been evaluated in the Phase 2a BIRCH clinical trial in patients with spontaneous intracerebral hemorrhage (ICH), a type of hemorrhagic stroke. ICH occurs when a blood vessel within the brain ruptures, leading to bleeding within the brain tissue.

ICH accounts for approximately 10–15% of all stroke cases and is associated with high mortality and morbidity. Despite its severity, therapeutic options remain limited, particularly for addressing the secondary brain injury that follows the initial hemorrhage.

The Phase 2a BIRCH study has now been completed. BIOX-101 was safe and well tolerated in patients with spontaneous ICH, and initial efficacy findings support its further clinical investigation as a potential therapeutic intervention for ICH.

INCLUSION CRITERIA

    • Male or female ≥ 18 years.
    • Written informed consent must be obtained before any study assessment, with legal representative consent acceptable if the patient is unable to provide it.
    • First-ever, spontaneous, supratentorial ICH.
    • Glasgow Coma Scale best motor score no less than 5.
    • mRS score 0-2 prior to symptom onset.

EXCLUSION CRITERIA

    • History of personal or familial bleeding disorders.
    • Known deficiency in factor XII or haemophilia type A or type B or type C.
    • Infratentorial ICH.
    • Secondary ICH.
    • Planned (neuro)surgical intervention on initial presentation.
    • Anticoagulation reversal treatment.
    • Patients with a Graeb score >3, blood in the 4th ventricle, significant blood in the 3rd ventricle, or hydrocephalus.
    • Use of immunosuppressive or immune-modulating therapy at admission.
    • Patients with active systemic bacterial, viral or fungal infections.
    • Women of childbearing potential.
    • Body weight > 120 kg at screening.
    • Severe renal impairment.

The completed Phase 2a BIRCH trial provided encouraging clinical findings for BIOX-101 in spontaneous intracerebral hemorrhage. BIOX-101 was safe and well tolerated. The Data Monitoring Committee unanimously recommended to move straight to the next-stage trial after second interim results. This was a strong validation of how compelling the data are, and shows the program is derisked.