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DJ Spero Therapeutics: FDA Puts Clinical Hold on SPR720 Phase 2a Trial >SPRO

· 02/05/2021 08:20

By Colin Kellaher

Spero Therapeutics Inc. Friday said the U.S. Food and Drug Administration has placed a clinical hold on the company's Phase 2a clinical study of its SPR720 antibacterial agent in patients with nontuberculous mycobacterial pulmonary disease.

The Cambridge, Mass., clinical-stage biopharmaceutical company said the hold comes after it paused dosing in the trial following events in an ongoing animal toxicology study of SPR720, in which deaths with inconclusive causality to treatment were observed in adult non-human primates.

Spero, which initiated the Phase 2a study in December, said it hasn't seen any serious adverse events in human participants.

Spero said it received verbal notification of the clinical hold from the FDA, but that it hasn't yet received written notice from the agency. The company said is in talks with the FDA to evaluate the findings and to determine the further development pathway for the SPR720 clinical program.

Trading in shares of Spero, which closed Thursday at $19.04, was halted premarket on Friday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 05, 2021 08:20 ET (13:20 GMT)

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