GSK: Gepotidacin EAGLE-1 Phase III Trial In GC Reports Positive Headline Results

(RTTNews) - British drug maker GSK plc (GSK, GSK.L) announced Monday positive headline results from EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic, in uncomplicated urogenital gonorrhoea or GC in adolescents and adults.

The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular or IM ceftriaxone (500mg) plus oral azithromycin (1,000mg), a combination treatment regimen for gonorrhoea.

The company plans to present the detailed results from the EAGLE-1 trial at an upcoming scientific meeting and to be shared with global health authorities.

Gonorrhoea is a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae. The World Health Organisation has recognised·Neisseria gonorrhoeae as a priority pathogen, for which resistance to existing treatments is rising.

Gonorrhoea, if left untreated or inadequately treated, can lead to infertility and other sexual and reproductive health complications. It also increases the risk of HIV infection.

GSK now said the positive trial result is based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit 3-7 days after treatment.

The safety and tolerability profile of gepotidacin in the EAGLE-1 phase III trial was consistent with results seen in gepotidacin phase I and II trials.

Chris Corsico, Senior Vice President, Development, GSK, said, "With rising incidence rates and concern around growing resistance to existing treatments, gonorrhoea poses a threat to public health globally. These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance."

Gepotidacin, a late-stage antibiotic in GSK's industry-leading infectious diseases portfolio, is also in development for uncomplicated urinary tract infections or uUTI.

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