Topoisomerase IV

GSK on Wednesday spelled out more details on a positive Phase III trial of its investigational antibiotic gepotidacin as a potential new treatment for uncomplicated urogenital gonorrhea.The roughly 600-patient EAGLE-1 trial, which was toplined earlier this year, met its primary endpoint. Gepotidacin achieved a 92.6% microbiological success rate and demonstrated non-inferiority to the leading combination of intramuscular ceftriaxone plus oral azithromycin, which had 91.2% success rates.Safety and tolerability of gepotidacin in EAGLE-1 was similar to findings from earlier Phase I and II trials. Adverse events were typically mild or moderate, with the most common side effects being gastrointestinal. There was one severe and one serious event in the gepotidacin arm, although both cases were considered unrelated to the drug. Results will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) at the end of the month.Rising drug-resistant infectionsChris Corsico, head of development at GSK, said, "These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide, including drug-resistant infections." Each year, about 82 million new cases of gonorrhoea occur worldwide, and there has been a 118% increase in reported cases in the US from 2009 to 2021, with about half resistant to at least one antibiotic.Analysts at Barclays recently highlighted gepotidacin's dual-targeting mechanism against the DNA gyrase and topoisomerase IV enzymes as a key advantage in overcoming antibiotic resistance. They project peak sales could reach £801 million ($996 million) for the first-in-class antibiotic, if approved.Beyond EAGLE-1, GSK has also reported positive Phase III data from the EAGLE-2 and EAGLE-3 trials evaluating gepotidacin for uncomplicated urinary tract infections (uUTI). The company is gearing up for regulatory submissions; it expects to file for uUTI next half, followed by a submission for urogenital gonorrhoea in 2025.GSK had previously targeted its uUTI filing by mid-2023, but told FirstWord on Wednesday that it is "working with the FDA, ahead of submission, to include additional non-clinical data requested by FDA to support its filing package."Elsewhere in its antimicrobials pipeline, GSK struck a licencing deal with Spero Therapeutics in 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated UTIs. And last year, it partnered with Scynexis on the antifungal Brexafemme (ibrexafungerp) to treat vulvovaginal candidiasis (VVC) and reduce the incidence of recurrent VVC.

DUBLIN, Nov. 23, 2023 /PRNewswire/ -- The "Prosthetic joint infections - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Prosthetic joint infections pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. "Prosthetic joint infections- Pipeline Insight, 2023" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Prosthetic joint infections pipeline landscape is provided which includes the disease overview and Prosthetic joint infections treatment guidelines. The assessment part of the report embraces, in depth Prosthetic joint infections commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Prosthetic joint infections collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Prosthetic joint infections R&D. The therapies under development are focused on novel approaches to treat/improve Prosthetic joint infections. Prosthetic joint infections Emerging Drugs Chapters This segment of the Prosthetic joint infections report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Prosthetic joint infections Emerging Drugs TNP 2092: TenNor Therapeutics TNP-2092 is a multi-targeting drug conjugate that exerts antibacterial activity by inhibiting three essential targets in bacterial biofilms: RNA polymerase, DNA gyrase and topoisomerase IV. TNP-2092 has demonstrated strong bactericidal activity, a low frequency for the development of resistance, and an excellent safety profile. The drug is in Phase II clinical developmental studies for the treatment of bacterial infections and skin and soft tissue infections. In January 2020, TenNor Therapeutics received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections. PLG0206: Peptilogics PLG0206 is an intravenous antibiotic derived from the cationic antibiotic peptide (eCAP) platform. PLG0206 works by targeting and disrupting bacterial membranes leading to the death of bacterial cells. PLG0206 has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for the treatment of prosthetic joint infections (PJI). Currently, the drug is in the Phase I stage of its development for the treatment of PJI. Prosthetic joint infections: Therapeutic Assessment This segment of the report provides insights about the different Prosthetic joint infections drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Prosthetic joint infections There are approx. 5+ key companies which are developing the therapies for Prosthetic joint infections. The companies which have their Prosthetic joint infections drug candidates in the most advanced stage, i.e. phase II include, TenNor Therapeutics. Prosthetic joint infections: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Prosthetic joint infections therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Prosthetic joint infections drugs. Key Questions Answered How many companies are developing Prosthetic joint infections drugs? How many Prosthetic joint infections drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Prosthetic joint infections? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Prosthetic joint infections therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Prosthetic joint infections and their status? What are the key designations that have been granted to the emerging drugs? Key Players Adaptive Phage Therapeutics TenNor Therapeutics Peptilogics Key Products Bacteriophage TNP 2092 PLG0206 Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Prosthetic joint infections Report Insights Prosthetic joint infections Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Prosthetic joint infections Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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