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.

Plano, TX – December 11, 2024 – Okogen Inc., a company specializing in innovative eyecare solutions, today announced the successful completion of $3.3 million in financing. The funding will advance the company through the completion of the Phase 2b clinical program for acute infectious conjunctivitis (“AIC”) and the development of an AI-driven image based evaluation platform designed for telehealth and at home application. These initiatives reinforce Okogen’s mission to address the unmet needs of the AIC market while exploring complementary pipeline opportunities. A clinical data readout from the Phase 2b program is anticipated in Q4 2025. “We are excited to announce the completion of our latest financing and the launch of our AI-enabled platform,” said Joshua Moriarty, CEO of Okogen. “This milestone reinforces our commitment to delivering comprehensive therapeutic solutions for patients suffering from AIC. Our focus remains on developing innovative, first-in-class products that improve outcomes for patients and efficiency for providers alike.” The Series B funding supports pivotal transition for Okogen from a single-asset company focused solely on OKG-301, a viral conjunctivitis treatment, to a broader platform approach. This platform combines a novel AI and image based patient evaluation tool with the development of OKG-0303, a triple-combination eyedrop targeting bacterial and viral conjunctivitis. By integrating evaluation and treatment, Okogen aims to address significant gaps in managing this highly contagious condition. “The global market for treating acute infectious conjunctivitis is vast, with millions of cases diagnosed annually across all age groups,” said Bradford Conlan, Chairman of the Board. “This condition poses substantial healthcare costs and productivity losses. Our AI-enabled platform offers a comprehensive solution to aid in patient evaluation while delivering time and cost savings for patients, payers, and healthcare providers.” Headquarters Relocation to Plano, Texas In line with its growth strategy, Okogen has relocated its headquarters from San Diego, California, to Plano, Texas. The move positions the company closer to critical resources and infrastructure, further accelerating the development and commercialization of its groundbreaking therapies. About Acute Infectious Conjunctivitis Pink eye (acute infectious conjunctivitis) is when the conjunctiva is irritated by a viral or bacterial infection. The current conjunctivitis market is USD $4.2 billion annually and is estimated to grow beyond USD $6.0 billion by 2031. Bacterial and viral conjunctivitis are easily spread from person to person if left untreated or properly diagnosed. There are currently no approved treatments for adenoviral conjunctivitis, comprising +90% of all viral ocular infections. About Okogen Okogen, Inc. is a cutting-edge eyecare product development company focused on delivering patient-centric solutions, with a current focus on acute infectious conjunctivitis. The company’s lead product, OKG-0303, is a triple-active combination eyedrop designed to treat both forms of acute infectious conjunctivitis, bacterial and viral, safely and effectively. In addition to advancing its Phase 2b clinical program, Okogen is developing an AI-powered evaluation tool aimed at improving patient care. The company is committed to innovation and expects a Phase 2b data readout by Q4 2025.