GSK announces positive data from phase 3 trial for new UTI antibiotic

Clinical Trials

GSK has shared positive data from its phase 3 trial for gepotidacin as a new oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and adolescents.

The drug is in late stage development in GSK’s infectious diseases portfolio and the positive data from the EAGLE-2 and EAGLE-3 phase 3 trials have been stopped early for efficacy following a recommendation from the Independent Data Monitoring Committee (IDMC) in November 2022.

The trial data was presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark, although full results are expected to be submitted for publication in a peer-reviewed journal later in 2023.

In both phase 3 trials, the drug demonstrated non-inferiority to nitrofurantoin, an existing treatment for uUTIs. In the EAGLE-3 trial, gepotidacin demonstrated statistically significant superiority compared to nitrofurantoin. Both results are based on a primary efficacy endpoint of therapeutic success, in the form of an eradication of bacteria at the Test-of-Cure visit 10-13 days after the beginning of the treatment.

The safety and tolerability profile of gepotidacin remained consistent with information from previous trials.

Chris Corsico, senior vice president of Development at GSK, commented: “Despite uUTIs being one of the most common infections in women and mounting concern about rising resistance rates to existing treatments, there has been no new class of antibiotics for over 20 years. We believe that gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI. We are committed to working with global regulators to bring this new antibiotic to patients as quickly as possible.”

Dr Florian Martin Erich Wagenlehner, principal investigator for the EAGLE-2 phase 3 trial, added: “These results are a significant step forward in an area that has seen very little innovation for decades. Gepotidacin is the first antibiotic to meet contemporary regulatory criteria, which set a high threshold for the efficacy of treatments in uUTIs. Gepotidacin has the potential to offer healthcare professionals another oral option to treat this common community infection.”

Eli Lilly’s tirzepatide achieves 15.7% weight loss in adult patients

Eli Lilly has announced that tirzepatide (10mg and 15mg) achieved significant and superior weight loss compared to a placebo over 72 weeks of treatment. This data follows results from the surmount-2 trial, which met all co-primary and secondary endpoints.

AstraZeneca and Ionis share positive results from phase 3 trial for eplontersen

AstraZeneca and Ionis have announced positive results from their phase 3 neuro-ttransform trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (attrv-pn), showing that the companies’ drug eplontersen met all primary and secondary endpoints at 66 weeks compared to an external placebo group.

AbbVie shares results from phase 3 trial for atogepant migraine treatment

AbbVie has shared positive results from its phase 3 elevate study, which assessed atogepant for the preventative treatment of episodic migraines in patients who have previously had two to four unsuccessful classes of oral preventive medications.

Eli Lilly shares positive results from phase 3 study of donanemab for early Alzheimer’s disease

Eli Lilly has announced positive results from the trailblazer-alz 2 phase 3 trial assessing donanemab’s ability to slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease.

Vicore announces initiation of proof-of-concept study for endothelial dysfunction treatments

Vicore Pharma Holding AB has announced that it has dosed the first patient with C21 in its randomised, double-blind, placebo-controlled, cross-over clinical study of endothelial dysfunction.

Eli Lilly’s tirzepatide achieves 15.7% weight loss in adult patients

AstraZeneca and Ionis share positive results from phase 3 trial for eplontersen

AbbVie shares results from phase 3 trial for atogepant migraine treatment

Eli Lilly shares positive results from phase 3 study of donanemab for early Alzheimer’s disease

Vicore announces initiation of proof-of-concept study for endothelial dysfunction treatments

Pharmafocus

Categories

Social Footprints