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A Randomized, Partially Blinded, Placebo- and Comparator-Controlled, Multicenter, Phase 2a, Dose Ranging, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SPR720 as Compared With Placebo or Standard of Care for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

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Trial Profile

A Randomized, Partially Blinded, Placebo- and Comparator-Controlled, Multicenter, Phase 2a, Dose Ranging, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SPR720 as Compared With Placebo or Standard of Care for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Status: Suspended
Phase of Trial: Phase II

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Fobrepodacin (Primary) ; Azithromycin; Clarithromycin; Ethambutol; Rifabutin; Rifampicin
  • Indications Nontuberculous mycobacterium infections
  • Focus Pharmacokinetics; Proof of concept
  • Sponsors Spero Therapeutics

Most Recent Events

  • 13 May 2025 Status changed from discontinued to suspended.
  • 13 May 2025 According to a Spero Therapeutics media release, the oral development program in NTM-PD was suspended in 4Q 2024. This followed a planned interim analysis of 16 patients dosed in the Phase 2a study, which demonstrated the study did not meet its primary endpoint.
  • 13 May 2025 According to a Spero Therapeutics media release, the Company is currently completing analysis of the data from all 25 patients dosed in the Phase 2a proof-of-concept study in NTM-PD and plans to determine next steps for the program.

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