Business
Spero Therapeutics Announces Second Quarter 2021 Operating Results and Provides Business Update
Tebipenem HBr on track for NDA submission in the fourth quarter of 2021 Announced $40 million equity investment from Pfizer Inc. and licensing agreement for
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Tebipenem HBr on track for NDA submission in the fourth quarter of 2021 Announced $40 million equity investment from Pfizer Inc. and licensing agreement for SPR206 Initiated Phase 1 bronchoalveolar lavage and renal impairment clinical trials of SPR206 Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing treatments in areas of high unmet need, involving multi-drug resistant bacterial infections and rare diseases, today announced financial results for the second quarter ended June 30, 2021, and provided a business update. “During the second quarter, we achieved key milestones which has us well positioned for future success, as we work to submit the tebipenem HBr NDA, transition to a commercial organization, and advance our clinical-stage pipeline,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “These accomplishments were bolstered by the recent $40 million equity investment from Pfizer Inc., along with their licensing agreement for SPR206. These agreements provide important external validation for our broader corporate strategy and demonstrate the depth and value of our early-stage programs.” Dr. Mahadevia continued, “Looking forward, our primary focus is to advance tebipenem HBr towards an NDA filing this year, which moves us closer to providing an oral treatment for potentially millions of patients with complicated urinary tract infections. We expect these activities, together with the advancement of our pipeline programs, to drive sustainable growth in our mission to address crucial unmet medical needs.” 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. Spero completed a pre-NDA meeting with the FDA in March 2021, the purpose of which was to discuss the f...