Business
Spero Therapeutics Announces Third Quarter 2023 Operating Results and Provides a Business Update
Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO trial of tebipenem HBr; Trial expected to begin with First Patient, First Visit in 4Q 2023
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO trial of tebipenem HBr; Trial expected to begin with First Patient, First Visit in 4Q 2023 Conference call and webcast at 4:30pm ET today CAMBRIDGE, Mass., Nov. 13, 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 third quarter ended September 30, 2023, and provided a business update. \"Having made substantial progress across our late-stage programs throughout 2023, we look forward to important milestones before year-end,” said Sath Shukla, President, and Chief Executive Officer of Spero. “In our SPR720 program, enrollment for our Phase 2 clinical proof-of-concept trial, evaluating the product in non-tuberculous mycobacterial pulmonary disease, continues to advance. Enrollment of our first patients in the Phase 3 PIVOT-PO clinical trial of tebipenem HBr is expected to begin in the fourth quarter. Further, we expect to file an IND for SPR206, in the fourth quarter of this year, as well, with the goal of conducting a Phase 2 clinical trial in patients with hospital-acquired or ventilator-associated bacterial pneumonia.\" Program Highlights and Upcoming Anticipated Milestones Tebipenem HBr Spero received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).PIVOT-PO is a global, randomized, double-blind, pivotal Phase 3 clinical trial of oral tebipenem HBr vs. intravenous (IV) imipenem cilastatin, in hospitalized adult patients with cUTI/AP. Patients will be randomized 1:1 to receive tebipenem HBr (600 mg) orally every six hours, or imipenem cilastatin (500 mg) IV every six hours, for a total of seven to ten days. The primary efficacy endpoint will be overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. The primary analysis for the trial will be an assessment of non-inferiority (NI) in the microbiol...