Business
Spero Therapeutics Announces First Quarter 2021 Operating Results and Provides Business Update
Tebipenem HBr remains on track for NDA submission in the second half of 2021 Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., May 06,
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Tebipenem HBr remains on track for NDA submission in the second half of 2021 Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., May 06, 2021 (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 bacterial infections and rare diseases, today announced financial results for the first quarter ended March 31, 2021 and provided a business update. “We are off to a strong start in 2021 and I am very pleased with the progress we have made across our pipeline,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We recently completed a pre-NDA meeting for tebipenem HBr with the FDA and received feedback indicating that the format and content of the planned data package we intend to include in our NDA will be sufficient to support the submission. This regulatory milestone keeps us on track to submit the NDA in the second half of the year as we work to transition to a commercial-stage organization. Our Phase 3 ADAPT-PO data indicate that, if approved, tebipenem HBr may provide many of the over 2 million cUTI and acute pyelonephritis patients who would typically receive IV therapy the convenience of an oral treatment with comparable efficacy and safety. Replacing IV therapy with an oral option may help avoid unnecessary hospitalizations, delivering substantial value to payers, physicians, and most importantly, patients.” Clinical Highlights and Upcoming Milestones Tebipenem HBr:Spero’s lead product candidate, tebipenem HBr, has the potential to be the first oral carbapenem antibiotic, if approved, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis (AP). In September 2020, Spero announced positive data from the Phase 3 ADAPT-PO trial showing that oral tebipenem HBr was statistically non-inferior to intravenous ertapenem in the treatment of patients with cUTI and patients with AP. In March 2021, Spero successfully completed a pre-new drug application (NDA) meeting with the United States Food and Drug Administration (FDA). The purpose of the meeting was to discuss the format and content of Spero’s planned NDA submission. Subject to FDA’s review of the full submission, Spero and the FDA...