Basilea Pharmaceutical has completed a Phase I study to test the efficacy of its novel sulfactam antibiotic BAL30072 as a treatment of multi-drug resistant Gram-negative infections.
The double-blind, randomised, and placebo-controlled dose-ranging study assessed the pharmacokinetics, safety and tolerability of BAL30072 in healthy volunteers, following multiple ascending doses of intravenous infusions.
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The trial demonstrated that the drug was well tolerated with no significant clinical adverse events, and displayed dose-proportional pharmacokinetic properties.
Basilea chief medical officer Achim Kaufhold said the company will now optimise alternative dosing regimens, including combinations.
"Co-administration of BAL30072 with other antibiotics such as the penem class follows the observation that combinations extend the excellent spectrum of activity of BAL30072 against multi-drug resistant Gram-negative infections, involving Pseudomonas, Acinetobacter and Enterobacteriaceae even further," Kaufhold added.
