Motif Bio (MTFB) , the clinical-stage biopharmaceutical company, told investors that the US Food & Drug Administration (FDA) has granted the Company’s request for a meeting to discuss Iclaprim.
Iclaprim is designed to be effective against serious and life-threatening infections caused by multi-drug resistant Gram-positive bacteria, including MRSA (known as “superbugs”).
Motif Bio received a Complete Response Letter from the FDA on 14 February 2019, regarding its New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections.
The company confirmed that the FDA had no questions over the clinical efficacy of Iclaprim. However the FDA did state that it needs additional data to further evaluate the risk for liver toxicity before the NDA approval.
The meeting is scheduled to take place on May 3, 2019.
Graham Lumsden, Chief Executive Officer of Motif Bio, said: "We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts.”
“We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval."
Shares in Motif Bio rose 19% to 7.05p a share
Official meeting minutes are received from the FDA typically within 30 days of a meeting. After this, the company told investors it will provide an update to the market on the path forward for Iclaprim.
The company said it needs to raise additional capital in the near term, with an announcement to be made in due course.
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