GSK plc ( GSK ) and Spero Therapeutics Inc ( SPRO ) on Wednesday announced that the pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs) will stop early for efficacy. 

Spero’s stock price was up 245.89% at last check Wednesday following the news.

The decision follows a recommendation from an Independent Data Monitoring Committee (IDMC) based on a planned interim analysis of data from 1,690 patients enrolled in the study. 

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If approved, tebipenem HBr would be the first oral carbapenem antibiotic for patients in the U.S. who suffer from cUTIs. It would add to GSK’s anti-infectives portfolio and help address the challenges of antimicrobial resistance (AMR).

The trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on the overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. 

The IDMC review did not identify any new safety concerns beyond those reported in other studies with tebipenem. Diarrhea and headache are the two most reported adverse events. 

GSK plans to work with U.S. regulatory authorities to include the data in a filing in 2025.

GSK’s Chief Scientific Officer Tony Wood said there are limited oral options for drug-resistant infections. This contributes to over $6 billion per year in US healthcare costs.

 An estimated 2.9 million cases of cUTIs are treated annually in the U.S. alone. The current standard of care includes carbapenem antibiotics, especially in case of sepsis and allergies or resistance to other antibiotics, but they are only available for IV administration.

Federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA) support the development of tebipenem HBr.

It is GSK’s second anti-infective program to be stopped early for efficacy in Phase 3, following the EAGLE 2 and EAGLE 3 trials for gepotidacin in 2022.

In March, the US Food and Drug Administration (FDA) approved GSK’s Blujepa (gepotidacin) for female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs).

In September 2022, GSK entered into an exclusive license agreement with Spero Therapeutics ( SPRO ) to develop and commercialize tebipenem HBr in all markets except certain Asian territories. 

Price Action: GSK is down 0.33%, trading at around $39.32 per share.

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