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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Apr 2025

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At a glance

  • Drugs Ir-CPI (Primary)
  • Indications Cerebral haemorrhage
  • Focus Adverse reactions; Proof of concept
  • Acronyms BIRCH
  • Sponsors Bioxodes

    • Most Recent Events

    • 03 Apr 2025 Status changed from recruiting to active, no longer recruiting.
    • 12 Feb 2025 According to the Bioxodes media release, Bioxodes is planning to present an interim analysis of these patients when the data become available. Bioxodes is also expecting an imminent response from U.S. and EU regulators about its Orphan Drug Designation for BIOX-101, which it applied for in the fourth quarter of 2024. ICH
    • 12 Feb 2025 According to the Bioxodes media release, In the first half of this year, company will update investors about a number of crucial milestones, including the strengthening of our top management, interim results from the BIRCH Phase 2a study, a decision about the Orphan Drug Designation of BIOX-101, and our Series B funding round.

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