Business
Spero Therapeutics Announces First Quarter 2023 Operating Results and Provides a Business Update
Phase 2 trial of SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD) on track for top line data readout in 1H 2024 Update on status of Special
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Phase 2 trial of SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD) on track for top line data readout in 1H 2024 Update on status of Special Protocol Assessment agreement for tebipenem HBr program expected mid-year 2023; initiation of Phase 3 trial in complicated urinary tract infection (cUTI) expected in 2H 2023 Conference call and webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., May 11, 2023 (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 rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the first quarter ended March 31, 2023, and provided a business update. “Momentum continues to build across our late-stage programs, each of which targets a clear medical need in an indication with a robust market and a favorable commercial landscape, ripe for innovation,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “SPR720’s Phase 2 clinical proof of concept trial in NTM-PD continues to advance, with a top line data readout expected in the first half of 2024. In parallel, we continue to engage with the FDA on a Special Protocol Assessment agreement for a pivotal Phase 3 trial of tebipenem HBr in cUTI, expected to start later this year. We also expect to file an IND for SPR206 in the fourth quarter of this year, preparing for a Phase 2 trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia.” Program Highlights and Upcoming Anticipated Milestones SPR720: The Phase 2 clinical trial of SPR720, a potential novel first-line oral therapy for nontuberculous mycobacterial (NTM) infections, continues to enroll participants with more than 15 active sites and top line data expected in the first half of 2024. The trial is expected to enroll up to 35 treatment-naïve or treatment-inexperienced participants with NTM-PD due to Mycobacterium avium complex. The primary endpoint of the trial evaluates changes in bacterial load in sputum samples from baseline to the end of the 56-day treatment period. Key secondary endpoints include assessments of clinical response, quality of life, SPR720 pharmacokinetics, and safety and tolerability. For more information on the trial and i...