SPY380.36-1.97 -0.52%
DIA309.45-4.53 -1.44%
IXIC13,192.35+72.96 0.56%

Spero Therapeutics Shares Fall After FDA Orders Clinical Hold on Mycobacterial Lung Disease Trial

· 02/05/2021 04:29

09:17 AM EST, 02/05/2021 (MT Newswires) -- Shares of Spero Therapeutics (SPRO) fell 16% in premarket Friday trading after the company said the Food and Drug Administration has ordered a clinical hold on its phase 2a clinical trial of SPR720, an oral antimicrobial agent being evaluated in patients with nontuberculous mycobacterial pulmonary disease.

The clinical hold comes after Spero decided to halt dosing based on the recommendation of the safety review board after reviewing data from an ongoing toxicology study of SPR720 in adult non-human primates in which mortalities with inconclusive causality to treatment were observed. No serious adverse events were detected in human participants, according to Spero.

The biopharmaceutical firm said that the FDA clinical hold was communicated verbally and that it has yet to receive a written notice from the agency. It is also in discussion with the FDA to evaluate the findings and identify a regulatory pathway for the SPR720 clinical program.

Price: 16.00, Change: -3.04, Percent Change: -15.97