Business
Spero Therapeutics Announces Second Quarter 2023 Operating Results and Provides a Business Update
SPA Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr Phase 3 PIVOT-PO trial is expected to begin with First Patient, First Visit in 4Q 2023 Sath
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"SPA Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr Phase 3 PIVOT-PO trial is expected to begin with First Patient, First Visit in 4Q 2023 Sath Shukla Became President and CEO, Effective August 1 Conference call and webcast at 4:30pm ET today CAMBRIDGE, Mass., Aug. 10, 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, announced today financial results for the second quarter ended June 30, 2023, and provided a business update. \"We are very pleased with the progress across our late-stage programs during the second quarter and in recent weeks,” said Sath Shukla, President, and Chief Executive Officer of Spero. \"Receipt of the written agreement from the FDA, under a Special Protocol Assessment, regarding the overall design of our planned pivotal Phase 3 PIVOT-PO study, was a crucial milestone in our tebipenem HBr program. We look forward to enrolling the first patients in the trial, which we expect to begin in the fourth quarter of this year. Additionally, enrollment for our Phase 2 clinical proof-of-concept trial evaluating SPR720 in non-tuberculous mycobacterial pulmonary disease continues to advance. Lastly, we also expect to file an IND for SPR206 in the fourth quarter of this year, with the goal of conducting a Phase 2 trial in patients with hospital-acquired or ventilator-associated bacterial pneumonia.\" Program Highlights and Upcoming Anticipated Milestones Tebipenem HBr On July 31, 2023, Spero announced that it 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, Phase 3 clinical trial of oral tebipenem HBr vs. intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The FDA has indicated that positive and persuasive results from PIVOT-PO, along with previously completed studies, could be sufficient to support approval of tebipenem HBr as a treatment for cUT...