Basilea initiates multiple ascending dose phase I study with novel antibiotic BAL30072 active against multidrug-resistant Gram-negative bacteria
Category: BioValleyBasel, Switzerland - Basilea Pharmaceutica Ltd. announced the initiation of the second phase I study with its novel sulfactam antibiotic BAL30072.
Gram-negative pathogens account for more than a third of all hospital infections and over half of the infections occurring in intensive care units. Infections with multidrug-resistant Gram-negative bacteria are associated with increased mortality, prolonged hospital stays and higher healthcare costs.
"We are very excited by the development of BAL30072. It has the potential to fill the enormous treatment gap against resistant Gram-negative bacteria that are claiming the lives of patients in increasing numbers. This multiple dose study will build upon the excellent results from our first human study of BAL30072 and we aim to complete this second study in the first part of 2012," said Dr. Anthony Man, CEO of Basilea Pharmaceutica International Ltd.
BAL30072 is a novel sulfactam antibiotic that in in vitro and in vivo models demonstrated potent bactericidal activity against a broad range of multidrug-resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. It overcomes bacterial resistance by several mechanisms and is not easily destroyed by bacterial beta-lactamase enzymes, such as extended-spectrum beta-lactamases (ESBLs), carbapenemases and the recently characterized New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance against many currently marketed antibiotics.
Following the successful completion of the single ascending dose phase I trial, in which BAL30072 was safe and well tolerated and displayed dose-proportional pharmacokinetic properties, Basilea is now commencing a double-blind, randomized, placebo-controlled study that assesses the pharmacokinetics, safety and tolerability of BAL30072 after multiple ascending intravenous infusions in healthy volunteers.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea Pharmaceutica International's fully integrated research and development operations are focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only approved treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, Finland, France, Germany, Norway, Switzerland and the United Kingdom and has appointed distributors for Toctino® in other selected European markets, Canada, Israel, Mexico and the Republic of Korea. A phase III clinical program on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S.
For its phase III compound isavuconazole, a potential best-in-class azole antifungal for the treatment of life-threatening invasive fungal infections, the company has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc.
In addition, Basilea is developing ceftobiprole, a late-stage novel anti-MRSA (methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin antibiotic, for the first-line treatment of potentially life-threatening resistant bacterial infections. Ceftobiprole has a broad coverage of both Gram-positive bacteria, including MRSA, and many clinically important Gram-negative bacteria such as Pseudomonas spp.
Basilea's BAL30072, a novel antibiotic for the treatment of resistant Gram-negative infections, and the oncology drug BAL101553 for the treatment of drug-resistant cancers are in phase I clinical testing.
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceuti