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Spero Therapeutics Announces Positive Recommendation to Continue Phase 3 Clinical Trial of SPR994 as Planned Following Independent Review Committee Analysis of SPR994 Treated Patients in Lead-in Cohort of Trial
CAMBRIDGE, Mass., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today announced that an independent review committee evaluated pharmacokinetic data following enrollment of the first 70 patients in Spero’s ongoing ADAPT-PO pivotal Phase 3 clinical trial of SPR994, Spero’s oral carbapenem product candidate, and recommended that Spero continue the trial using the protocol-defined dose without modification. \n “The Phase 3 trial is designed to evaluate whether an oral-only regimen of SPR994 can achieve an outcome similar to that observed with an intravenous antibiotic therapy in patients with complicated urinary tract infections. If SPR994 achieves this outcome and is ultimately approved, we believe it would represent a critical clinical and economic value proposition for the more than two million patients resistant to oral therapies currently used to treat such infections,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “A primary objective of the independent review committee was to confirm that plasma levels of SPR994 in patients in the Phase 3 trial support the selected treatment dose consistent with our goals for the trial. We are very pleased that the independent review committee, after reviewing data from 33 patients who had been randomized to SPR994 in the Phase 3 trial, determined that the plasma levels of SPR994 in those patients were suitable and recommended that we continue the trial without dose modification. This decision, based on patient data in context of our clinical trial, gives us additional confidence in SPR994’s potential to meet the needs of patients with resistant infections. Enrollment continues to be on track, and we expect to report top-line data from the Phase 3 trial in the third quarter of 2020.” The independent review committee reviewed interim plasma concentration data from 33 patients who were randomized to SPR994 in the ongoing ADAPT-PO pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). ADAPT-PO is designed as a double-blind, double-dummy clinical tria...