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Motif Bio Poised For Filings As Iclaprim Succeeds Again In Phase III

 
• By Alexandra Shimmings

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.

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Motif Bio Getting Ready to pounce on $2bn+ market • Source: Shutterstock

Success in a second Phase III trial of Motif Bio PLC's lead product positions the company for its first filing application for its novel antibiotic iclaprim in acute bacterial skin and skin structure infections (ABSSSI). The product, however, has been brought before the regulators before, and success this time would be the culmination of a long and chequered development story.

Iclaprim was set on its way to final success when positive results from the first Phase III trial REVIVE-1 were reported in April, and following the latest data, a US submission is slated for the first quarter of 2018

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