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A single pivotal Phase 3 study of MAT2203 treatment in patients with invasive aspergillosis with limited or no treatment options

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Trial Profile

A single pivotal Phase 3 study of MAT2203 treatment in patients with invasive aspergillosis with limited or no treatment options

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2024

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At a glance

  • Drugs Amphotericin B (Primary)
  • Indications Aspergillosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ORALTO trial
  • Sponsors Matinas BioPharma

Most Recent Events

  • 27 Mar 2024 According to a Matinas BioPharma media release, the company is engaged in active dialogues with potential partners and is seeking to finalize a partnership as soon as possible in order to commence the Phase 3 ORALTO trial.
  • 20 Feb 2024 According to a Matinas BioPharma media release, ORALTO will be a global trial conducted at approximately 65 investigator sites in the U.S., Europe, South America, Middle East, and Asia Pacific. Enrollment is expected to commence in the second half of 2024 and is expected to require approximately 24 months.
  • 20 Feb 2024 According to a Matinas BioPharma media release, Once approximately 75% of participants are enrolled, an independent Data Safety Monitoring Board will review the overall pooled all-cause mortality rate in a blinded fashion to ensure that the sample size assumptions are reasonable and that the study is adequately powered. Should the pooled event differ substantially from expected levels, a sample size adjustment can be made to the trial.

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