BRIEF — Motif Bio antibiotic gets FDA review

UK biopharma Motif Bio (AIM: MTFB) was up 6% in late London trading on Tuesday after the US Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for iclaprim, a targeted, gram-positive investigational antibiotic for acute bacterial skin and skin structure infections (ABSSSI).

The NDA has been granted priority review, and the FDA has set a target decision date under the Prescription Drug User Fee Act of February 13, 2019.

The submission includes data from two Phase III trials evaluating iclaprim for the treatment of patients with ABSSSI. In both studies, iclaprim achieved the primary endpoint of non-inferiority compared to vancomycin, the current standard of care, at the early time point of 48 to 72 hours after the start of administration of the study drug.

More than 3.6 million patients with ABSSSI are hospitalized annually in the USA. It is estimated that up to 26% of hospitalized ABSSSI patients have renal impairment.

Hospitalized patients with obesity, diabetes and/or poor kidney function are particularly vulnerable to vancomycin-associated kidney injury. Many standard of care Gram-positive antibiotics are not suitable for treatment of hospitalised ABSSSI patients with these conditions due to efficacy or safety issues.

Graham Lumsden, chief executive of Motif Bio, said: “We believe that, if approved, iclaprim could be an important new treatment option for patients with serious skin infections.

“We look forward to working closely with the FDA as we move through the review process with the goal of bringing iclaprim to patients as quickly as possible.”