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.
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.
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