GlaxoSmithKline ((GSK)), GlaxoSmithKline plc (UK) ((GB:GSK)), Spero Therapeutics ((SPRO)) announced an update on their ongoing clinical study.
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GlaxoSmithKline and Spero Therapeutics have completed a Phase 3 clinical study titled A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP). The study aimed to evaluate the efficacy of oral TBP-PI-HBr versus intravenous imipenem-cilastatin in treating hospitalized adults with cUTI or AP, focusing on clinical cure and microbiological eradication.
The study tested two interventions: the experimental oral drug TBP-PI-HBr and the active comparator, intravenous imipenem-cilastatin. TBP-PI-HBr is intended to provide an effective oral treatment option for cUTI or AP, potentially offering a more convenient alternative to intravenous therapy.
This interventional study was randomized with a parallel assignment model and triple masking, involving participants, investigators, and outcomes assessors. The primary purpose was treatment-focused, aiming to determine the effectiveness of the oral medication compared to the standard IV treatment.
The study began on December 21, 2023, and was last updated on June 30, 2025. These dates are crucial as they mark the study’s progression and the latest information available, indicating the study’s completion and the availability of updated data.
The completion of this study could significantly impact GSK and Spero Therapeutics’ stock performance, as a successful outcome may enhance investor confidence and market positioning. The introduction of an effective oral treatment could also influence the competitive landscape in the pharmaceutical industry, especially in the treatment of urinary tract infections.
The study is now completed, with further details accessible on the ClinicalTrials portal for those interested in the comprehensive data and results.