Gonorrhea

GSK is setting aside a mid-stage 24-valent pneumococcal vaccine program for adults to instead focus on a preclinical option that covers 30-plus valents, the company announced Wednesday alongside its third-quarter earnings. The decision reflects “increased competition” in the pneumococcal space, a GSK spokesperson told Endpoints News. A 30-valent product for adults would put GSK in rivalry with Vaxcyte’s 31-valent candidate, which read out positive Phase 1/2 results last month. Vaxcyte said at the time that it plans to launch a Phase 3 study in mid-2025. Pfizer, which has also been a fierce competitor in the pneumococcal space, said earlier this week that it has a preclinical 30-plus-valent vaccine in the works. GSK expects to take its 30-plus candidate to the clinic next year, CSO Tony Wood said during a call with investors. The company is still developing a 24-valent candidate for use in children. Elsewhere, GSK culled three other Phase 2 programs, including an anti-CCL17 antibody for osteoarthritis pain, dubbed GSK3858279, and a gonorrhea candidate, called GSK4348413. The spokesperson said an interim Phase 2 analysis for the gonorrhea asset in patients at high risk of infection “did not meet our pre-defined efficacy criteria.” The spokesperson added that there were no safety concerns. The UK pharma also discontinued a Phase 2 program for Herpes simplex virus, GSK3943104, which “did not meet the study’s primary efficacy objective” in the Phase 2 portion of a Phase 1/2 trial. That decision was previously announced in September.

16 October 2024 Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials 26 March 2025 assigned as action date for FDA decision Gepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs). The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025. Over half of all women are affected by uUTIs in their lifetime1, with approximately 30% suffering from recurrent disease which can cause significant patient burden, including discomfort and restriction of daily activities.2 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.3 Gepotidacin is a late-stage antibiotic in GSK’s growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years. The NDA is supported by positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI, in female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (treatment difference 14.6%, 95% CI (6.4, 22.8)). In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (treatment difference 4.3%, 95% CI (-3.6, 12.1)). The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhoea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the maximum severity were mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (gepotidacin and nitrofurantoin) across the two trials. The development of gepotidacin has been funded 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. About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III programme The global phase III clinical programme for gepotidacin in adults and adolescents consists of three trials: 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) with 1531 and 1605 female adults and adolescents with uncomplicated urinary tract infections, respectively. Across both trials, the duration of follow-up for participants was approximately 28 days, and the primary endpoint was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae. About gepotidacin Gepotidacin, discovered by GSK scientists, is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as E. coli and S. saprophyticus), and N. gonorrhoeae, including isolates resistant to current antibiotics. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhoea phase III clinical trials, including those with drug-resistant pathogens. Due to the well-balanced inhibition, gepotidacin target-specific mutations in both enzymes are needed to significantly affect susceptibility to gepotidacin. Therefore, leading to a lower potential for resistance development. GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. GSK’s expertise and capabilities in innovation, access and stewardship position the Company uniquely to help prevent and mitigate the challenge of antimicrobial resistance. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like

WALTHAM, Mass.--(BUSINESS WIRE)-- Innoviva Specialty Therapeutics, Inc. , a biotechnology company focused on delivering innovative therapies in critical care and infectious diseases, announced today the presentation of data from three clinical abstracts and two oral presentations on the company’s pipeline and Commercial portfolio during IDWeek 2024 , October 16-19, 2024, in Los Angeles, CA. “Our clinical program continues to provide important findings from recent sub-analyses that add meaningful new insights for healthcare professionals managing difficult-to-treat and antimicrobial-resistant pathogens,” said David Altarac, MD, Chief Medical Officer at Innoviva Specialty Therapeutics. “We are pleased with the progress of our development product zoliflodacin, which recently completed the pivotal phase 3 trial conducted with our partner the Global Antibiotics Research Development Partnership. If approved, zoliflodacin could lead to the first new oral antibiotic to treat gonorrhea in decades.” IDWeek 2024 Clinical Presentations Oral Presentation Addressing a growing global threat through a novel public-private development partnership David Altarac, MD, Chief Medical Officer, Innoviva Specialty Therapeutics Friday, October 18, 2024 8:00 am – 9:00 am PT Petree C Oral Presentation Activity of Sulbactam-durlobactam and Standard-of-Care Antibiotics against Acinetobacter baumannii-calcoaceticus complex isolates acquired from Hospitalized Patients in the United States (2023 – 2024) Tomefa E. Asempa, PharmD, Hartford Hospital Saturday, October 19, 2024 10:54-11:06 am PT Room 403A Poster #P-1103 In Vitro Activity of Zoliflodacin Against Baseline Neisseria gonorrhoeae Isolates from US Participants in a Global Phase 3 Randomized Controlled Trial Sarah McLeod, PhD, Innoviva Specialty Therapeutics Friday, October 18, 2024 12:15-1:30 pm PT, Hall J&K Poster #P-1251 Pharmacometric Analyses to Support Dose Selection of Zoliflodacin, a First-in-Class Oral Antibiotic Being Developed for the Treatment of Uncomplicated Gonorrhea Sujata M. Bhavnani, MD, Institute for Clinical Pharmacodynamics Friday, October 18, 2024 12:15-1:30 pm PT, Hall J&K Time Poster# P-1532 Surveillance of Eravacycline Against CLINICAL Pathogens, including Resistant Isolates, Collected Worldwide from Multiple Infection Sites During 2018-2022 Kristie Zappas, PharmD, Innoviva Specialty Therapeutics Friday, October 18, 2024 12:15-1:30 pm PT, Halls JK About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ product, through its affiliate, Entasis Therapeutics Inc., include XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex ( Acinetobacter ). For more information about Innoviva Specialty Therapeutics, please visit here . Contacts Media Contact : David Patti Innoviva Corporate Communications David.patti@inva.com 908.421.5971