StockMarketWire.com - The US Food and Drug Administration has agreed to the proposed phase 3 development programme for Amphion partner company Motif Bio'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 of 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 HAPB 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. The first phase 3 trial for ABSSSI is expected to start in the second half of this year. Amphion owns 44.09% of Motif's issued equity in addition to a convertible loan in the amount of $3.55m.


At 9:29am:

[LON:AMP] Amphion Innovations PLC share price was +0.13p at 6p

[LON:MTFB] Motif Bio Plc Ord 1p share price was -0.87p at 28.63p



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