FDA slaps clinical hold on antibiotics trial after deaths in monkey trial spurred concerns
One of the more prominent players still standing in the antibiotics field has run into a big hurdle as the FDA slapped a clinical hold on its Phase IIa trial.
Spero Therapeutics said the official hold comes — via verbal notification — after it notified regulators of its decision to pause dosing in the study, which was testing SPR720, its second drug, for nontuberculous mycobacterial pulmonary disease. Scientists had uncovered “mortalities with inconclusive causality” in a toxicology study involving non-human primates, and the Safety Review Board recommended that they hit the brakes.
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