Conjunctivitis, Bacterial

GENEVA & LAUSANNE, Switzerland--( BUSINESS WIRE )--The Global Antibiotic Research & Development Partnership (GARDP) and the Swiss-based global biopharmaceutical company Debiopharm have signed a memorandum of understanding to develop Debio 1453, a novel compound representing a new antibiotic class that targets Neisseria gonorrhoeae . Multidrug-resistant strains of N. gonorrhoeae have emerged globally, limiting treatment options and elevating this pathogen to the high-priority category on the World Health Organization’s Bacterial Priority Pathogen List. Such pathogens present distinct public health challenges that urgently require new treatments. “Antibiotic-resistant gonorrhoea represents a serious threat to sexual and reproductive health,” said Morgane Vanbiervliet, Manager of Market Intelligence & Business Development, Infectious Diseases, Debiopharm. “Debio 1453 shows encouraging pre-clinical efficacy against resistant strains of N. gonorrhoeae . We are eager to continue to develop this compound in collaboration with GARDP.” Debiopharm has completed the preclinical development of Debio 1453 with ongoing support from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The MOU between Debiopharm and GARDP now sets the stage for a new partnership to develop the compound for regulatory approval and help make the final product available and affordable to treat patients worldwide. “We are very pleased to lay the groundwork for a future partnership with Debiopharm,” said Yann Ferrisse, Director of Business Development at GARDP. “In line with our 2024-2028 strategy, we will continue to identify new opportunities like Debio 1453 to develop and make available treatments for gonorrhoea and other public health threats.” Innovative approaches are necessary to treat N. gonorrhoeae , which has gradually developed resistance to many classes of antibiotics used to treat gonorrhoea infections. A single muscular injection of ceftriaxone is now the last available recommended treatment globally. Recent reports of outbreaks of ceftriaxone-resistant “super gonorrhoea” have heightened the urgency for new antibiotic treatments. Debio 1453 shows promising activity against ceftriaxone-resistant and other multidrug-resistant strains of N. gonorrhoeae . The compound uses a unique and novel mechanism of action to target the FabI enzyme, on which N. gonorrhoeae relies for its growth and survival. In studies thus far, no cross-resistance to any antibiotic class has been observed. With more than 82 million new gonorrhoea infections occurring globally each year, gonorrhoea is the third most common sexually transmitted infection. It can cause serious, lifelong consequences in men and women, and can amplify the spread of HIV in high-prevalence settings. When left untreated in women, gonorrhoea can lead to pelvic inflammatory disease that elevates the risk of complications in pregnancy, including the likelihood of ectopic pregnancies and infertility. Gonorrhoea can also be transmitted during birth to babies, who in turn can have health problems like gonococcal conjunctivitis. Debiopharm Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We’re on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews GARDP We are a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. We receive vital support from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Bill & Melinda Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. We are GARDP, the Global Antibiotic Research & Development Partnership. www.gardp.org *CARB-X is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Research reported in this press release is supported by CARB-X. CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views CARB-X or its funders.

Geneva and Lausanne, Switzerland, 14 January 2025 – The Global Antibiotic Research & Development Partnership (GARDP) and the Swiss-based global biopharmaceutical company Debiopharm have signed a memorandum of understanding to develop Debio 1453, a novel compound representing a new antibiotic class that targets Neisseria gonorrhoeae. Multidrug-resistant strains of N. gonorrhoeae have emerged globally, limiting treatment options and elevating this pathogen to the high-priority category on the World Health Organization’s Bacterial Priority Pathogen List. Such pathogens present distinct public health challenges that urgently require new treatments. “Antibiotic-resistant gonorrhoea represents a serious threat to sexual and reproductive health.” said Morgane Vanbiervliet, Manager of Market Intelligence & Business Development, Infectious Diseases, Debiopharm. “Debio 1453 shows encouraging pre-clinical efficacy against resistant strains of N. gonorrhoeae. We are eager to continue to develop this compound in collaboration with GARDP.” Debiopharm has completed the preclinical development of Debio 1453 with ongoing support from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The MOU between Debiopharm and GARDP now sets the stage for a new partnership to develop the compound for regulatory approval and help make the final product available and affordable to treat patients worldwide. “We are very pleased to lay the groundwork for a future partnership with Debiopharm,” said Yann Ferrisse, Director of Business Development at GARDP. “In line with our 2024-2028 strategy, we will continue to identify new opportunities like Debio 1453 to develop and make available treatments for gonorrhoea and other public health threats.” Innovative approaches are necessary to treat N. gonorrhoeae, which has gradually developed resistance to many classes of antibiotics used to treat gonorrhoea infections. A single muscular injection of ceftriaxone is now the last available recommended treatment globally. Recent reports of outbreaks of ceftriaxone-resistant “super gonorrhoea” have heightened the urgency for new antibiotic treatments. Debio 1453 shows promising activity against ceftriaxone-resistant and other multidrug-resistant strains of N. gonorrhoeae. The compound uses a unique and novel mechanism of action to target the FabI enzyme, on which N. gonorrhoeae relies for its growth and survival. In studies thus far, no cross-resistance to any antibiotic class has been observed. With more than 82 million new gonorrhoea infections occurring globally each year, gonorrhoea is the third most common sexually transmitted infection. It can cause serious, lifelong consequences in men and women, and can amplify the spread of HIV in high-prevalence settings. When left untreated in women, gonorrhoea can lead to pelvic inflammatory disease that elevates the risk of complications in pregnancy, including the likelihood of ectopic pregnancies and infertility. Gonorrhoea can also be transmitted during birth to babies, who in turn can have health problems like gonococcal conjunctivitis. Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We’re on X. Follow us @DebiopharmNews at https://x.com/DebiopharmNews We are a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. We receive vital support from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Bill & Melinda Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. We are GARDP, the Global Antibiotic Research & Development Partnership. www.gardp.org *CARB-X is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Research reported in this press release is supported by CARB-X. CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views CARB-X or its funders.

MILAN, Dec. 5, 2024 /PRNewswire/ -- NTC, an international R&D focused pharmaceutical company headquartered in Italy, presents positive results from Phase II MIRAKLE study, a multicentre, randomized, blinded-assessor, phase II non-inferiority study evaluating the efficacy and tolerability of NTC014 (quinolone antibiotic + NSAID in eye drops solution) in the treatment of bacterial conjunctivitis in adults. Despite NTC014, due to its simplified therapeutic regimen, has been administered at a lower posology than the antibiotic comparator –25% of less antibiotic administered - the main results showed the non-inferiority of NTC014 eye drops vs antibiotic alone in microbiological eradication, with unexpected efficacy results even against pathogens classified as Intermediate or Resistant to the quinolone antibiotic under study. "These interim findings reaffirm that NTC014 is eligible to be a new treatment for bacterial conjunctivitis", Alessandro Colombo, Chief Scientific Officer, NTC, states. "We aim at demonstrating with robust clinical evidence value and potential for NTC014, considering also that this drug responds to our mission to contribute to fighting antibiotic resistance by using less antibiotics, for a shorter treatment duration with no limitation of usage, also in case of non-confirmation of bacterial etiology." "We are encouraged by the overall results of the Mirakle study", says Riccardo Carbucicchio, Chief Executive Officer in NTC, "NTC 014 is first in class combination worldwide of an antibiotic and an NSAID. Given the significant unmet medical need, NTC014 aims to provide physicians with an effective treatment for moderate-severe bacterial conjunctivitis, a common eye infection. We believe that NTC 014 has a great potential and we aim to finalize the commercial partnering for this asset in most countries of the world before end of 2025. We do not exclude to develop this asset for surgical use too". Conjunctivitis is a common disease in Western Countries and imposes economic and social burdens. Viral conjunctivitis is the most common cause of infectious conjunctivitis both overall and in the adult population, bacterial conjunctivitis is the second most common cause and is responsible for the majority (50%-75%) of cases in children. NTC has already successfully developed and launched the first combination of a quinolone and steroid for post cataract surgery1, licensed in almost 90 countries and currently marketed in 60 countries, in Europe, Asia, Americas and Africa. About NTC A pharmaceutical company headquartered in Milan - Italy, with distributors and partners in more than 100 countries, engaged in research, development, registration, and commercialization of drugs, medical devices, and food supplements in ophthalmology, and other therapeutic areas including pediatrics, gynecology, and gastroenterology. NTC offers more than 200 partners innovative and high quality standard pharmaceutical products. For more information, please visit 1. Bandello F., et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye (2020), Logo - SOURCE NTC Srl WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED