Business
Spero Therapeutics Announces Second Quarter 2020 Operating Results and Provides Business Update
Top-line data for Phase 3 ADAPT-PO trial evaluating oral tebipenem HBr in complicated urinary tract infection expected in 3Q20 Conference call and live
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Top-line data for Phase 3 ADAPT-PO trial evaluating oral tebipenem HBr in complicated urinary tract infection expected in 3Q20 \n Conference call and live webcast at 4:30 p.m. EDT today CAMBRIDGE, Mass., Aug. 06, 2020 (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 second quarter ended June 30, 2020 and provided a business update. “I am very pleased with our recent progress, as we are well positioned for the third quarter with top-line data from our Phase 3 ADAPT-PO clinical trial comparing oral tebipenem HBr to IV ertapenem expected before quarter end,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We believe that tebipenem HBr, if approved, will have a significant benefit on the more than two million patients with avoidable hospitalizations for complicated urinary tract infections, and that the need for new, efficacious oral agents to keep patients out of the hospital has never been greater.” Clinical Highlights and Upcoming Milestones COVID-19 Update: Spero remains committed to advancing its clinical programs while protecting the safety and well-being of patients, physicians and their staff. Spero is continuing to monitor and take steps to mitigate any effects of the COVID-19 pandemic on its business and clinical programs, while the U.S. Food and Drug Administration (FDA) is working with sponsors given the challenges the health crisis presents to conducting ongoing trials. Despite Spero’s best efforts to control the impact of the COVID-19 pandemic on its clinical trials and timelines, its clinical research organizations (CROs) are experiencing reduced capacity to conduct, validate and analyze trials, which Spero anticipates will have an effect on the timelines of its ongoing and planned Phase 1 clinical trials. Specifically, Spero believes a delay in Phase 1 trial readouts will affect the timing of the completion of its planned new drug application (NDA) submission for tebipenem HBr in complicated urinary tract infection (cUTI) as well as the initiation of its planned SPR206 Phase 1 bronchoalveolar lavage (BAL) clinical trial. As ...