Clinical Trials

All products

Products

Ir-CPI (BIOX-101)

This First-In-Human (Phase I) study is a double blind, placebo controlled, single ascending dose trial performed in healthy adult male volunteers with Ir-CPI (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 Ir-CPI.
- Secondary study objectives included pharmacokinetic (PK) and pharmacodynamic (PD) assessment of Ir-CPI, i.e. the effect on prolongation of the aPTT coagulation parameter and on the inhibition of FXI and FXII 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 Ir-CPI ranging from 1.5 mg/kg up to 9 mg/kg were tested and administered intravenously for a 6-h period of infusion.
Ir-CPI (BIOX-101)

This Phase IIa study aims to evaluate the safety, tolerability and the effects of Ir-CPI (BIOX-101) in adult patients with spontaneous intracerebral hemorrhage (BIRCH trial)
- ClinicalTrials.gov Trial Identifier NCT05970224
- Recruitment status Recruiting
- 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

Summary of the Clinical Data

Ir-CPI was well tolerated with no dose-limiting toxicities; there were no safety issues, no related serious adverse events nor adverse events of specific interest, i.e. adverse events related to bleeding.

Plasma exposure during infusion (AUC0-6h) and mean peak plasma concentrations increased dose-proportionally. PK profile of escalating single IV infusion doses of Ir-CPI in healthy male participants was characterized by maximum mean plasma concentrations observed at the end of infusion (i.e. 6 hours). Exposure-dependent changes were observed in the PD parameters: prolongation of the aPTT and inhibition of FXI and FXII procoagulant activities. There was a correlation between Ir-CPI plasma concentrations and biological activity.

For more information, please read the Press Release here

See also our ongoing Phase IIa trial with Ir-CPI in patients suffering from spontaneous intracerebral haemorrhage.

Study Design

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

Ir-CPI (BIOX-101), a promising new therapeutic candidate, is currently undergoing evaluation in a Phase IIa clinical trial including patients with spontaneous intracerebral hemorrhage (ICH), also known as hemorrhagic stroke. This condition occurs when a blood vessel within the brain ruptures, leading to bleeding within the brain tissue. ICH is a particularly devastating form of stroke due to its sudden onset and the severe neurological damage it can cause.

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.

Ir-CPI aims to fill this critical gap. The Phase IIa trial is designed to assess its safety, tolerability, and preliminary efficacy in patients who have suffered from spontaneous ICH. 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, Ir-CPI 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.