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A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients With Treatment-refractory Mycobacterium Avium Complex Lung Disease

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Trial Profile

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients With Treatment-refractory Mycobacterium Avium Complex Lung Disease

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Epetraborole (Primary)
  • Indications Mycobacterium avium complex infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors AN2 Therapeutics

Most Recent Events

  • 01 May 2025 According to an AN2 Therapeutics media release, primary endpoint (QOL-B respiratory domain PRO score change from baseline to treatment at month 6) has not been met.
  • 01 May 2025 According to an AN2 Therapeutics media release, the company announced topline results from the Phase 3 portion of this study
  • 25 Mar 2025 According to an AN2 Therapeutics media release, the Company plans to review both Phase 2 and Phase 3 results with the FDA and discuss potential registrational pathways.

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