Aankondiging • Aug 06
Basilea Pharmaceutica Ltd Receives Additional Funding to Continue Development of Novel Antibiotic Ceftibuten-Ledaborbactam Etzadroxil Basilea Pharmaceutica Ltd. has been awarded an additional USD 5.4 million of funding by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, to continue the development of the novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. After this additional funding of USD 5.4 million, a total of USD 30.8 million of funding has been awarded to Basilea by BARDA. The contract has the potential to provide a total of up to USD 172 million of non-dilutive funding, of which approximately USD 14 million relate to the period prior to novation of the contract to Basilea. Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections caused by multidrug-resistant bacterial pathogens. Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales. Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options. Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). Aankondiging • Jul 29
Basilea Receives USD 30 Million Funding Under Existing BARDA Agreement for Advancing Phase 3 Development of Novel Antifungal Fosmanogepix Basilea Pharmaceutica Ltd, Allschwil announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), awarded USD 30 million in additional funding to Basilea after meeting its prespecified enrollment milestone. The additional funding will continue to advance Basilea’s ongoing phase 3 program for the novel antifungal, fosmanogepix. The commitment is made under the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033). The new tranche of USD 30 million comes in addition to the USD 93 million already committed by BARDA since the signing of the OTA in September 2024. BARDA’s financial contribution is about 60% of the total costs of the supported projects, fosmanogepix and BAL2062, including clinical and regulatory activities, over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million over up to 12 years, if all additional options to extend the contract are exercised by BARDA. Fosmanogepix is a first-in-class clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order. Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections. The FAST study, a phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis and the FORWARD study, a phase 3 study, in the treatment of adult patients with invasive mold infections, are ongoing. Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). BAL2062 is a first-in-class clinical-stage antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains. Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses. The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. Aankondiging • May 28
Basilea Pharmaceutica Ltd Receives Additional USD 13.3 Million From BARDA To Continue Development Of Novel Antibiotic Ceftibuten-Ledaborbactam Etzadroxil Basilea Pharmaceutica Ltd, Allschwil announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, awarded USD 13.3 million to Basilea to continue the development of Basilea’s novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. After the current tranche of USD 13.3 million, a total of USD 25 million have been committed by BARDA. The contract could provide up to USD 133 million of additional non-dilutive funding. Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections caused by multidrug-resistant bacterial pathogens. Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales. Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options. Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). Aankondiging • Apr 27
Basilea Pharmaceutica AG to Report First Half, 2026 Results on Aug 18, 2026 Basilea Pharmaceutica AG announced that they will report first half, 2026 results on Aug 18, 2026 Aankondiging • Apr 17
Basilea Pharmaceutica AG Approves Board and Committee Appointments Basilea Pharmaceutica Ltd. at its annual general meeting held on April 15, 2026, approved election of Dr. Naseem Amin and Ms. Anne Whitaker as new members of the board of directors. In addition, Mr. Kruimer, Dr. Onetto and Ms. Anne Whitaker were appointed as members of the compensation committee. The term of all board members lasts until the AGM 2027. Aankondiging • Apr 11
Basilea Pharmaceutica Ltd Announces Additional Funding for Clinical Development of Antibiotic BAL2420 Basilea Pharmaceutica Ltd, Allschwil announced that it was awarded an additional USD 6 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 additional non-dilutive funding will support the first-in-human phase 1 clinical study of Basilea’s novel antibiotic BAL2420 (LptA inhibitor) and related activities. The phase 1 study has already been initiated, with the first subject dosed in March 2026. BAL2420 belongs to one of the very few novel classes of antibiotics in clinical 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. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have identified Enterobacteriaceae, including carbapenem-resistant strains, as high priority pathogens for which new and effective antibiotic treatments are urgently needed. CARB-X has supported the development of BAL2420 since 2020, advancing the project from the hit-to-lead stage to the first-in-human study. Research reported in this publication is supported by CARB-X. CARB-X is funded in part with 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 (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or its funders. 
