Basilea reports positive results from first clinical phase I study with its novel antibiotic BAL30072
Basel, Switzerland, May 25, 2011 - Basilea Pharmaceutica Ltd. (SIX:BSLN) reported today positive top-line results from the first clinical phase I study with its antibiotic BAL30072 which is being developed for the treatment of infections caused by multidrug-resistant Gram-negative bacteria. BAL30072 was safe and well tolerated in this single-ascending-dose study.
The double-blind randomized clinical phase I study investigated the safety, tolerability and pharmacokinetics of single ascending doses of BAL30072 in healthy volunteers. BAL30072 was safe and well tolerated at all dose levels. It displayed dose-proportional plasma levels as well as linear pharmacokinetic properties. Detailed study results will be presented at upcoming scientific conferences.
"We are delighted with the good safety and tolerability of BAL30072 demonstrated in this first study in man, which is in line with our preclinical observations," said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. "These results support the potential of BAL30072 as a new treatment option for severe and life-threatening infections caused by multidrug-resistant Gram-negative bacteria, where currently very limited therapeutic options exist. We are committed to addressing the significant medical challenge arising from the rapid global spread of new emerging Gram-negative superbugs and we will be further advancing the phase I program with this promising drug this year."
Clinically important multidrug-resistant Gram-negative pathogens such as Pseudomonas aeruginosa, Acinetobacter spp., Klebsiella spp. and Enterobacter spp. are associated with prolonged hospital stays, higher healthcare costs and increased mortality. These pathogens may cause serious and life-threatening infections such as sepsis, severe lung or complicated urinary tract infections. In a recent study which involved thousands of patients in intensive care units around the world, Gram-negative pathogens were found in about 60 percent of patients tested positive on bacterial infections.
BAL30072 is a novel siderophore (iron-binding) sulfactam antibiotic with a unique mode of action, conferring potent bactericidal activity against a broad range of multidrug-resistant Gram-negative pathogens such as Pseudomonas aeruginosa or Acinetobacter spp., as demonstrated in in vitro and in vivo models. BAL30072 is stable towards many types of bacterial beta-lactamase enzymes which inactivate most of the currently marketed beta-lactam antibiotics. This stability covers many of the extended-spectrum beta-lactamases (ESBLs) as well as carbapenemases and metallo-beta-lactamases such as New Delhi metallo-beta-lactamase 1 (NDM-1). A clinical phase I multiple-ascending-dose study with BAL30072 is anticipated to start in the second half of 2011.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Its 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 severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, Finland, France, Germany, Switzerland and the United Kingdom and has appointed distributors for Toctino® in other selected European markets, Canada, Israel and Mexico. Furthermore, 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 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 methicillin-resistant Staphylococcus aureus (MRSA), and many clinically important Gram-negative bacteria such as Pseudomonas spp.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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Posted: May 2011