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Antibiotics specialist Motif Bio (LON:MTFB) posted a net loss of $14 million for the year ended 31st December, less than a third of what was recorded for the previous year. Research and development expenses dropped steeply, largely due to the completion of the phase III trial iclaprim being completed during 2017.
CEO Dr Graham Lumsden commented: “Motif Bio had an incredibly productive year in 2018, including submitting a New Drug Application to the U.S. FDA for iclaprim for the treatment of patients with acute bacterial skin and skin structure infections. Unfortunately, in February 2019 we unexpectedly received a Complete Response Letter from FDA notifying Motif that the NDA for iclaprim could not be approved as submitted. The Agency has asked for additional data to assess the potential for liver toxicity and we have a confirmed FDA meeting date of May 3, 2019 to discuss the concerns noted in the Complete Response Letter. We expect to be joined at the meeting by two external experts and anticipate a collaborative discussion and hopefully an acceptable path forward. We believe that iclaprim can be a valuable option for patients and their providers who are in need of new antibiotic treatment options“.
The price of shares in the AIM-listed company dropped by 1.94% to 8.60p (as of 14:50 BST).