LONDON (Alliance News) - Biopharmaceutical company Motif Bio PLC Tuesday said it has received agreement from the US Food and Drug Administration for an optimised fixed dose of its antibiotic iclaprim in its proposed phase III trials in acute bacterial skin and skin structure infections.
The concurrence is for a fixed dose of 80 milligrams for all patients except those with moderate hepatic impairment.
"Concurrence from the FDA of the potential efficacy and safety benefits of this fixed dose regime is important for the iclaprim Phase III trials and, assuming approval, will offer clear benefits for practitioners and patients. The fixed dose regime should save significant time treating high risk patients where a rapid response is critical," said Motif Bio Chief Medical Officer David Huang in a statement.
Shares in Motif were down 4.5% at 53.50 pence Tuesday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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