GSK anuncia resultados adicionales de EAGLE-1
Deutsche Grundstuckautionen AG
€8.30
15:19 07/05/24
Emitido: 17 de abril de 2024, Londres, Reino Unido
EAGLE-1 phase III data show potential for gepotidacin as a new oral treatment option for uncomplicated urogenital gonorrhoea (GC) amid growing resistance to existing treatments
· Gepotidacin achieved a 92.6% microbiological success rate and was non-inferior al líder tratamiento combinado
· EAGLE-1 is the third positive pivotal trial for gepotidacin, a potential first-in-class oral antibiotic as part of GSK's industry-leading infectious diseases portfolio
· Results will be presented at European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global
GSK plc (LSE/NYSE: GSK) today announced positive results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. These results will be presented on 30 April 2024 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global in Barcelona, Spain.
The results from EAGLE-1 are based on a primary endpoint of microbiological response (success or failure of eliminating the bacterial cause of gonorrhoea) at the Test-of-Cure (ToC) visit 3-7 days after treatment. The trial showed that gepotidacin (oral, two doses of 3,000mg) was non-inferior with 92.6% success rates when compared to 91.2% success rates for intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhoea.
The safety and tolerability profile of gepotidacin in the EAGLE-1 trial was consistent with results seen in phase I and II trials. The most commonly reported adverse events (AEs) in gepotidacin subjects were gastrointestinal (GI). All AEs were mild or moderate (Grade 1 or 2) except for one severe (Grade 3), unrelated event in each treatment arm and one unrelated serious event in the gepotidacin arm.
There are an estimated 82 million new cases of gonorrhoea globally each year.[ 1 ] In the United States, rates of reported gonorrhoea have increased 118% from 2009 to 2021,[ 2 ] with 648,056 cases being reported to the US Centers for Disease Control and Prevention (CDC) in 2022.[ 3 ] The CDC also reported that approximately half of gonorrhoea cases each year in the US are resistant to one antibiotic.[ 4 ]
Chris Corsico, vicepresidente sénior de desarrollo de GSK, dijo: "These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections. The imperative for innovative treatments has never been clearer. We are committed to working with health regulators globally to introduce this potential new antibiotic, focusing on solutions that meet critical patient needs."
La gonorrea es una infección de transmisión sexual causada por una bacteria llamada Neisseria gonorrhoeae, which has been recognised by the World Health Organisation as a priority pathogen. It affects both men and women and if inadequately treated, it can lead to infertility and other sexual and reproductive health complications. It also increases the risk of HIV infection.
GSK is also developing gepotidacin for the potential treatment of uncomplicated urinary tract infections (uUTI). Positive phase III data from the EAGLE-2 and EAGLE-3 trials were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April 2023, and published in The Lancet.[ 5 ] Si se aprueba, la geopotidacina podría ser el primero de una nueva clase de antibióticos orales para las infecciones urinarias en más de 20 años. EAGLE-1 is the third positive pivotal trial for gepotidacin.
The development of gepotidacin has been funded in whole or in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002.
Acerca del programa de fase III EAGLE (Eficacia de la gepotidacina antibacteriana evaluada)
Ya se ha completado el programa clínico global de fase III para geopotidacina en adultos y adolescentes. El programa consta de tres ensayos:
EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in approximately 600 patients with uncomplicated urogenital gonorrhoea.
EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days). Across both trials, the duration for participants was approximately 28 days, and the primary endpoint was the combined clinical and microbiological response at the ToC visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin.
About Gepotidacin
La geopotidacina, descubierta por científicos de GSK, es un antibiótico triazaacenaftileno bactericida en investigación, el primero en su clase, que inhibe la replicación del ADN bacteriano mediante un nuevo mecanismo de acción y sitio de unión y, para la mayoría de los patógenos, proporciona una inhibición bien equilibrada de dos enzimas topoisomerasas de tipo II diferentes. Esto proporciona actividad contra la mayoría de las cepas de uropatógenos objetivo (como E. coli y S. saprophyticus), o N. gonorrhoeae, including isolates resistant to several antibiotics. Due to the well-balanced inhibition of two enzymes, gepotidacin target-specific mutations in both enzymes are needed to significantly affect gepotidacin susceptibility.
GSK en enfermedades infecciosas
GSK ha sido pionera en innovación en enfermedades infecciosas durante más de 70 años, y la cartera de medicamentos y vacunas de la compañía es una de las más grandes y diversas de la industria. La experiencia y las capacidades de GSK en innovación, acceso y administración posicionan a la compañía de manera única para ayudar a prevenir y mitigar el desafío de la resistencia a los antimicrobianos. En antimicrobianos, además de la geopotidacina, GSK firmó un acuerdo de licencia exclusiva con Spero Therapeutics, Inc. en septiembre de 2022 para agregar tebipenem HBr, un antibiótico en etapa avanzada y tratamiento potencial para infecciones complicadas del tracto urinario (ITUc), a la cartera. En marzo de 2023, GSK anunció un acuerdo de licencia exclusivo con Scynexis para Brexafemme (tabletas de ibrexafungerp), un antifúngico de primera clase para el tratamiento de la candidiasis vulvovaginal (VVC) y la reducción de la incidencia de VVC recurrente.
Sobre GSK
GSK es una compañía biofarmacéutica global cuyo propósito es unir la ciencia, la tecnología y el talento para adelantarnos juntos a las enfermedades. Obtenga más información en gsk.com.
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[ 1 ] Organización Mundial de la Salud, Gonorrea multirresistente. Disponible en: https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea
[ 2 ] Datos de los CDC en el archivo
[ 3 ] CDC, Sexually Transmitted Infections Surveillance. Available at: https://www.cdc.gov/std/statistics/2022/default.htm#:~:text=In%202022%2C%20more%20than%202.5,from%20all%20STI%20prevention%20partners
[ 4 ] Centers for Disease Control and Prevention. Combating the Threat. Available at: https://www.cdc.gov/std/gonorrhea/drug-resistant/carb.htm#:~:text=There%20are%20more%20than%20500%2C000%20reported%20cases%20of,year%20are%20resistant%20to%20at%20least%20one%20antibiotic.
[ 5 ] The Lancet, Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials, available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02196-7/abstract
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