Posted by Michael Wonder on 30 Mar 2019
Spero Therapeutics receives FDA fast track designation for SPR994 for the treatment of complicated urinary tract infections and acute pyelonephritis
29 March 2019 - Spero Therapeutics today announced that the U.S. FDA granted fast track designation for SPR994, Spero’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections and acute pyelonephritis.
Spero’s planned pivotal Phase 3 clinical trial of SPR994, ADAPT-PO, is designed as a double-blind, double-dummy trial to compare oral SPR994 with an existing standard of care intravenous (IV) antibiotic, ertapenem, in approximately 1,200 patients randomised 1:1 in each arm. The primary endpoint of the pivotal trial will be the combined clinical and microbiological response at the test of cure with a 10% non-inferiority margin versus IV ertapenem. Spero has begun start-up activities for the ADAPT-PO clinical trial and anticipates opening trial sites around the end of March 2019 to support study enrolment.
The trial will incorporate a lead-in cohort of 70 patients with an intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero expects to receive pharmacokinetic data from the lead-in cohort in the second half of 2019.
