Spero Therapeutics Inc (NASDAQ: SPRO) shares have fallen on Friday after the biopharmaceutical company announced that the United States Food and Drug Administration (FDA) has informed the company that a clinical hold has been placed on its Phase 2a clinical trial of SPR720.
The drug is Spero’s investigational oral antimicrobial agent being evaluated in patients with nontuberculous mycobacterial pulmonary disease.
The company said it received verbal notification of the clinical hold for the Phase 2a study but has not yet received written notice from the FDA.
The clinical hold follows Spero's notification to the FDA of its decision to pause the dosing in the trial as a precautionary measure following events in its ongoing animal toxicology study of SPR270. The decision to implement the pause was made based on a recommendation by the company’s safety review board following review data.
Ankit Mahadevia, IT companies managing director said: “At Spero, patient safety is of primary importance and we are committed to working with FDA to evaluate findings from our ongoing primate toxicology study in an effort to determine whether these findings are drug-related and what impact, if any, the study may have on the further evaluation of SPR720 in the Phase 2a clinical trial.”
Safety and tolerability of SPR720 were previously evaluated in a Phase 1 clinical trial completed in December 2019, with no serious adverse events reported.
Spero shares fell to lows of $14.02 following the news; however, they have regained some losses and are now trading at $15.95 down 16.23%
