Basilea initiates next phase 1 multiple ascending dose study

November 22, 2012 | by Peer Nils Schröder

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November 22, 2012, Basilea Pharmaceutica Ltd. (SIX:BSLN) announced today that it has initiated the next planned pharmacokinetic phase 1 healthy volunteer study in its clinical development program for BAL30072, Basilea's new investigational antibiotic with activity against multidrug-resistant Gram- negative bacteria.


Gram-negative pathogens account for approximately half of all hospital-acquired bacterial infections. Many Gram-negative pathogens have acquired the ability to produce enzymes that destroy beta-lactam antibiotics, which have been the mainstay of antibiotic therapy for several decades. Multidrug-resistant bacteria for which there are few or no therapeutic options available are being encountered with increasing frequency and are associated with increased mortality, prolonged hospital stays and higher healthcare costs.

BAL30072 is a novel injectable sulfactam antibiotic that in in-vitro and in-vivo models demonstrated potent bactericidal activity against a broad range of clinically relevant multidrug- resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. BAL30072 overcomes several mechanisms of bacterial resistance. In particular, it is not easily destroyed by bacterial enzymes such as extended-spectrum beta-lactamases (ESBLs), carbapenemases or the New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance to many marketed antibiotics.

Prof. Achim Kaufhold, Chief Medical Officer of Basilea, stated: "Due to its potent antimicrobial activity BAL30072 has the potential to play an essential role in the therapy of serious and life- threatening infections caused by Gram-negative bacteria for which currently only limited therapeutic options exist. We are now expanding our phase 1 clinical program for this promising drug candidate to optimize dosing regimens in preparation for phase 2 clinical studies.


Contact:
Basilea Peer Nils Schröder, Ph.D. Head Public Relations & Corporate Communications +41 61 606 1102 media_relations@basilea.com

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Source: Peer Nils Schröder, Press release