Motif A Step Closer To Succeeding With Iclaprim After Phase III Success
Biotech firm hopes its once-shelved antibiotic will provide a therapeutic option for renally impaired patients with serious skin infections. With only one previous DHFR inhibitor ever approved, Motif also anticipates that iclaprim will offer an option for multidrug-resistant infections.
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Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.
The latest drug development news and highlights from our US FDA Performance Tracker.
Positive data from a second Phase III trial sets up Motif Bio for an NDA filing by the end of the year for novel antibiotic iclaprim – but success for the product has been a long time coming.