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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