Colistin Sulfate

In a clinical study, Zaynich (Zidebactam/Cefepime, WCK 5222) demonstrated over 97 percent clinical efficacy in treating seriously ill patients with infections caused by carbapenemresistant (including meropenem-resistant) Gram-negative pathogens. The study design was unique as it encompassed a range of severe infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and complicated urinary tract infections (cUTI). 17 percent of these patients also had concurrent BSI thus further escalating the therapeutic challenge. The overall clinical efficacy of Zaynich across indications was 98 percent at the test-of-cure (TOC), which was 7-10 days after completion of treatment, while it was 100 percent for BSI, HABP/VABP and cIAI and 97.3 percent for cUTI. Notably, Zaynich also demonstrated high pathogen eradication rates (microbiological cure) including for tougher-to-treat HABP/VABP (91 percent) and BSI patients (100 percent). Taking into account the results from this clinical study as well as several patients successfully treated under compassionate use in India and US, lives of more than 100 critically ill patients, infected with life-threatening XDR Gram-negative infections have been saved with administration of Zaynich. Conducted across 15 top-rated tertiary care hospitals nationwide, this clinical study exclusively involved patients with confirmed carbapenem-resistant (including meropenem-resistant) infections, identified through advanced molecular rapid diagnostic technologies. The infecting pathogens were a diverse range of extensively drug-resistant (XDR) Gram-negatives such as Acinetobacter spp., Pseudomonas spp., Klebsiella spp., and E. coli. Treatment durations ranged from 7 to 21 days. The study protocol was duly approved by Drugs Controller General of India (DCGI). This study underscores the potential of Zaynich as a life-saving antibiotic, particularly for carbapenem-resistant infections. Current highly compromised treatment options are colistin and polymyxins, which are marred with significant toxicity and efficacy limitations. The significance of these findings is amplified by the world-wide threat posed by antimicrobial resistance. Zaynich targets all the Gram negative pathogens identified as critical priorities by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).

Additional funding awarded following successful drug candidate nomination USD 7.3 million to support progression of antibiotic BAL2420 (LptA inhibitor) towards first-in-human clinical studies December 23, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it was awarded an additional USD 7.3 million from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to supporting the early development of antibacterial products. The new funding supports the progression of Basilea’s novel antibiotic candidate BAL2420 (LptA inhibitor) towards the start of first-in-human clinical studies, which is expected mid-2026. Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: "We are very pleased by CARB-X’s continued support for the development of this promising first-in-class drug candidate. LptA inhibitors have the potential to address an unmet medical need in the hospital-based treatment of severe infections, caused by Gram-negative bacteria. We look forward to working with CARB-X to bring BAL2420 to patients." BAL2420 belongs to one of the very few novel classes of antibiotics in development. It is targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. LptA inhibitors have shown potent and rapid bactericidal activity in vitro and in vivo against Gram-negative bacteria of the Enterobacteriaceae family, such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy.1 Enterobacteriaceae have been highlighted by the World Health Organization (WHO) as priority pathogens, against which new antibiotics are urgently needed.2 Basilea has acquired the LptA antibiotics program from Spexis AG in early 2024. In April this year, Basilea announced that it was awarded an initial CARB-X grant of up to USD 0.9 million to support early preclinical activities. The successful completion of these activities resulted in the nomination of BAL2420 as a drug candidate and also led to a final milestone payment from Basilea to Spexis. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; 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 of CARB-X or any of its funders. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: December 22, 2024) The content above comes from the network. if any infringement, please contact us to modify.