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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: 28 Feb 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

    • 24 Feb 2025 According to an AN2 Therapeutics media release, company has amended the protocol and submitted an amended statistical analysis plan to the FDA for its Phase 3 EBO 301 trial, selecting the Quality of Life - Bronchiectasis (QOL-B) respiratory domain patient-reported outcome (PRO) instrument as the primary efficacy endpoint
    • 13 Nov 2024 According to an AN2 Therapeutics media release, Company also plans to seek alignment with the FDA on a statistical analysis plan for the 97 patients who completed six months of treatment in the Phase 3 portion of EBO-301 at the time the Company halted the trial in August 2024. The Company anticipates releasing top-line Phase 3 data from these patients in mid-2025, subject to the timing of discussions with the FDA.
    • 13 Nov 2024 According to an AN2 Therapeutics media release, company will seek an End-of-Phase 2 meeting with FDA in the first half of 2025, with the goal of leveraging insights from the Phase 2 results to evaluate potential reinitiation of a pivotal Phase 3 TR-MAC study.

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