Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that the United States Food and Drug Administration (FDA) informed Spero that a clinical hold has been placed on its Phase 2a clinical trial of SPR720, Spero’s investigational oral antimicrobial agent being evaluated in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).
Spero received verbal notification of the clinical hold for the SPR720 Phase 2a trial but has not yet received written notice from the FDA. The clinical hold follows the notification by Spero to the FDA of its decision to pause dosing in its ongoing Phase 2a clinical trial of SPR720 as a precautionary measure following events in its ongoing animal toxicology study of SPR720. The decision to implement the pause was made based on a recommendation from Spero’s Safety Review Board (SRB), following review of data from an ongoing toxicology study of SPR720 in adult non-human primates in which mortalities with inconclusive causality to treatment were observed. The animal study is being conducted to assess the potential toxicity of SPR720 over a 4-month duration. A concurrent 4-month study of SPR720 in rats is proceeding uneventfully. These studies are meant to support longer-term treatment with SPR720 beyond the 28 days currently supported by IND-enabling toxicology studies. Spero is in discussion with FDA to evaluate the findings and determine the further development pathway for the SPR720 clinical program. No serious adverse events have been observed in any human study participants.
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