Spero Therapeutics Says FDA Lifts Clinical Trial Hold On SPR720 - Quick Facts

(RTTNews) - Spero Therapeutics, Inc. (SPRO) announced Tuesday that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 2 trial of SPR720, Spero's investigational oral product candidate being developed for nontuberculous mycobacterial (NTM) disease.

The SPR720 program was placed on a clinical hold by the FDA following a review of data from a non-human primate (NHP) toxicology study in which mortalities with inconclusive causality to treatment were observed.

The FDA's decision to lift the hold follows Spero's submission of a comprehensive study report with detailed analyses from the NHP toxicology study.

Spero plans on engaging with the FDA in the first quarter of 2022 to discuss the re-initiation of the SPR720 Phase 2 trial for NTM-pulmonary disease (NTM-PD) patients, with an expected study start date commencing in the second half of 2022.

SPR720 represents a novel class of antibacterial agents that target enzymes essential for bacterial DNA replication. It is currently under development as an oral therapy for the treatment of non-tuberculous mycobacterial (NTM) disease, a rare orphan disease.