HQ Team
May 28, 2025: GSK Plc. and Spero Therapeutics have stopped their combined trial of an investigational oral treatment for urinary tract infections after the study achieved its goal on efficacy.
The study evaluated tebipenem HBr, and the decision follows after a recommendation from an Independent Data Monitoring Committee, based on a planned interim analysis of data from 1,690 patients enrolled in the trial, according to a GSK statement.
The trial showed that tebipenem HBr was as effective as intravenous imipenem-cilastatin in treating hospitalised adults with complicated urinary tract infections (cUTI), including kidney infections, based on overall patient recovery and infection clearance at the follow-up visit.
If approved, tebipenem HBr would be the first oral carbapenem antibiotic for patients in the US who suffer from complicated urinary tract infections, adding to GSK’s anti-infectives portfolio and helping address the challenges of antimicrobial resistance.
Intravenous
The current standard of care includes carbapenem antibiotics, especially in cases of sepsis and allergies or resistance to other antibiotics, but they are only available for intravenous administration.
Carbapenems are a subclass of antibiotics called beta-lactam antibiotics (antibiotics that have a chemical structure called a beta-lactam ring). Beta-lactam antibiotics also include cephalosporins, monobactams, and penicillins.
The broad-spectrum antibiotics are effective against many types of bacteria, including bacteria that are resistant to many other antibiotics.
In September 2022, GSK entered into an exclusive license agreement with Spero Therapeutics for the development and commercialisation of tebipenem HBr in all markets, except certain Asian territories.
FDA filing in second-half
GSK plans to work with US regulatory authorities to include the data as part of a filing in the second half of this year.
“The committee review did not identify any new safety concerns beyond what has been reported in other studies with tebipenem,” and diarrhoea and headache were the two most reported adverse events, according to GSK.
“Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock,” said Tony Wood, Chief Scientific Officer of GSK.
“Currently, many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections… these positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home.”
Multidrug-resistant pathogens
An estimated 2.9 million cases of cUTIs are treated annually in the US alone. These infections are often caused by multidrug-resistant pathogens and carry an increased risk of morbidity and mortality.
As per the 2022 agreement, GSK has sublicensed back to Spero Therapeutics the rights and responsibility to conduct certain development work, including the end-phase study, after which sponsorship of the new drug application will be transferred to GSK from Spero Therapeutics.
Tebipenem HBr has been granted Qualified Infectious Disease Product and Fast Track designations by the US Food and Drug Administration.
Esther Rajavelu, Chief Executive Officer, Spero, said: “Achieving the primary endpoint in the trial marks a significant milestone for tebipenem HBr. If approved, we believe tebipenem HBr is well-positioned to change the treatment landscape for patients diagnosed with cUTI, including pyelonephritis.”
