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Clinical trials

  • BIOX-101

    This Phase 2a trial aims to evaluate the safety, tolerability and the effects of BIOX-101 in adult patients with spontaneous intracerebral hemorrhage (BIRCH trial).

    • 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
    • Primary Completion Date (Estimated) August, 2025
    • Study Start Date July 27, 2023
    • Acronym BIRCH

     

     

  • 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 is currently undergoing evaluation in a Phase 2a clinical trial including patients with spontaneous ICH, also known as hemorrhagic stroke. This condition occurs when a blood vessel within the brain ruptures, leading to bleeding within the brain tissue. 

Hemorrhagic stroke accounts for about 10-15% of all stroke cases, but it results in a disproportionately high rate of mortality and long-term disability compared to ischemic strokes, which are caused by blockages rather than bleeding. The lack of effective treatments for ICH further compounds its impact on patients and healthcare systems. Currently, management of ICH focuses on supportive care and controlling risk factors, but no specific therapeutic agents have been approved to directly address the consequences of the hemorrhage.

BIOX-101 aims to fill this critical gap. The outcomes of this trial could pave the way for further research and development, potentially offering a much-needed treatment option for this life-threatening condition. If successful, BIOX-101 could significantly improve the prognosis and quality of life for patients affected by hemorrhagic stroke, marking a major advancement in stroke therapy.

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.

Bioxodes achieved encouraging preliminary results. The trial met primary safety and secondary efficacy endpoints, an interim analysis of the first 16 patients showed.