Spero Therapeutics announces FDA acceptance of SPR994 IND application.
Spero Therapeutics announced the acceptance by the FDA of its investigational new drug, or IND, application for SPR994, Spero's lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections, or cUTI. This IND acceptance will enable Spero to initiate U.S. enrollment in its planned global, single pivotal Phase 3 clinical trial of SPR994 in cUTI. 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, or IV, antibiotic, ertapenem, in approximately 1,200 patients randomized 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. The trial will incorporate a lead-in cohort of 70 patients with intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero anticipates receiving interim pharmacokinetic data from the trial's lead-in cohort in the second half of 2019. In addition, Spero will conduct routine ancillary clinical pharmacology studies in parallel with the ADAPT-PO clinical trial, including a renal insufficiency study, a thorough QT prolongation study and a drug-drug interaction study. Spero has begun start-up activities for the ADAPT-PO clinical trial and anticipates opening trial sites to support study enrollment in Q1.
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|Date:||Feb 4, 2019|
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