LONDON (Alliance News) - Motif Bio PLC said Monday its 2018 loss narrowed significantly as research costs fell, despite an unexpected delay in its new drug application in the US.
In 2018, pretax loss narrowed to USD14.0 million from USD44.8 million the year prior. The firm did not generate any revenue in either year.
Profit performance improved primarily because research & development costs fell sharply to USD11.0 million from USD29.5 million the year prior.
"Motif Bio had an incredibly productive year in 2018, including submitting a new drug application to the US FDA for iclaprim for the treatment of patients with acute bacterial skin and skin structure infections," Chief Executive Graham Lumsden said.
"Unfortunately, in February 2019 we unexpectedly received a complete response letter from the FDA notifying Motif 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," Lumsden added.
"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 iclaprim can be a valuable option for patients and their providers who are in need of new antibiotic treatment options."
Shares in Motif Bio were 3.9% lower at 8.42 pence on Monday.