StockMarketWire.com - Motif Bio said the US Food and Drug Administration (FDA) has agreed to the proposed Phase 3 clinical development programme for the Company's lead product candidate, iclaprim.

The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP) caused by Gram positive pathogens, including resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae).

The FDA confirmed that two ABSSSI trials or one ABSSSI trial plus one HABP trial meeting their pre-specified primary endpoints are required for approval of iclaprim. Motif is working to determine the costs and timeline of these options. Assuming that funds can be raised or a partnership can be entered into, the first Phase 3 trial for ABSSSI is expected to commence in the second half of 2015.




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