ARTICLE | Clinical News

Motif eyes NDA after second Phase III ABSSSI readout

October 4, 2017 9:11 PM UTC

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) gained 7.75p (21%) to 44.5p in London on Wednesday and rose $1.60 (16%) to $11.75 on NASDAQ after reporting that iclaprim (MTF-100) met the primary endpoint of non-inferiority to vancomycin in the Phase III REVIVE-2 trial to treat acute bacterial skin and skin structure infections (ABSSSIs). The company plans to submit an NDA to FDA for iclaprim by the end of 1Q18.

On the 600-patient trial's primary endpoint, 80 mg IV iclaprim every 12 hours for 5-14 days was non-inferior to vancomycin in early clinical response, defined as the proportion of patients achieving at least a 20% reduction in lesion area at the early time point 48-72 hours after the start of treatment (78.3% vs. 76.7%). The non-inferiority margin was 10%. Iclaprim was also non-inferior to vancomycin in the proportion of patients achieving clinical cure at the test-of-cure (TOC) visit 7-14 days after the end of treatment (78% vs. 77.7%)...

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