FDA accepts new drug application for Motif Bio's iclaprim

Clinical-stage biopharmaceutical company Motif Bio announced on Tuesday that the US Food and Drug Administration has accepted for filing its new drug application (NDA) for iclaprim - a targeted, gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The AIM-traded firm said that meant that the FDA had determined that the application was “sufficiently complete” to perform a substantive review.

It said the NDA had been granted ‘priority review’, and the FDA had set a target decision date under the Prescription Drug User Fee Act (PDUFA) of 13 February 2019.

“The NDA acceptance by the FDA is an important milestone for Motif Bio and reflects the dedication and commitment of our team who have worked tirelessly to accomplish this," said Motif Bio chief executive officer Graham Lumsden.

“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.”

Motif Bio said more than 3.6 million patients with ABSSSI were hospitalised each year in the US.

It was estimated that up to 26% of hospitalised ABSSSI patients had renal impairment.

Hospitalised patients with obesity, diabetes and poor kidney function were said to be “particularly vulnerable” to vancomycin-associated kidney injury.

Many standard-of-care gram-positive antibiotics were not suitable for the treatment of hospitalised ABSSSI patients with those conditions, due to efficacy and safety issues, Motif Bio explained.

It said the NDA included data from two Phase 3 trials - REVIVE-1 and REVIVE-2 - evaluating iclaprim for the treatment of patients with ABSSSI.

“In both trials, iclaprim achieved the primary endpoint of non-inferiority compared to vancomycin, the current standard of care, at the early time point, 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat patient population,” Motif Bio’s board explained in its statement.

“Iclaprim also achieved non-inferiority at the test of cure endpoint, seven to 14 days after study drug discontinuation, in the intent-to-treat patient population.”

Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA, the company added.

If iclaprim is approved as a new chemical entity with QIDP designation, it would be eligible for 10 years of market exclusivity in the US starting from the date of approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act).