Shares of Motif Bio plc shot up late Thursday after the company announced it had completed its rolling submission of a New Drug Application to the U.S. Food and Drug Administration for its acute bacterial skin and skin structure infections (ABSSSI) treatment, iclaprim.
Shares of United Kingdom-based Motif Bio plc shot up late Thursday after the company announced it had completed its rolling submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for its acute bacterial skin and skin structure infections (ABSSSI) treatment, iclaprim.
Motif Bio Chief Executive Officer Graham Lumsden called the NDA submission a “major milestone” for his company. Lumsden praised his team for the NDA and said the company looks forward to working with regulatory agents in order to bring the drug to market.
This is not the first time Iclaprim has gone to the FDA. In 2009 Arpida AG took Iclaprim to the FDA, but it was rejected due to safety concerns. Motif eventually acquired Iclaprim in 2013.
Motif’s Iclaprim has a targeted Gram-positive spectrum of activity, which makes it a more precise treatment. The company said this approach, which is different from broad-spectrum antibiotics, will avoid the build-up of resistance and to lessen the impact on the microbiome of the patient.
The NDA was based on two Phase III trials that showed Iclaprim, an investigational antibiotic, was effective in treating patients with ABSSSI. In the Revive-1 study, Iclaprim achieved the primary endpoint of non-inferiority against the current standard of care antibiotic, vancomycin at the early time point (ETP) of 48 to 72 hours after the initial administration of the drug. In its April 2017 Revive-1 announcement, Motif said an analysis of a pre-specified secondary endpoint showed that 60.4 percent of patients receiving iclaprim “demonstrated resolution or near resolution at end of therapy, compared to 58.3 percent of patients receiving vancomycin.
In the Phase III Revive-2 study, Iclaprim achieved the primary endpoint of non-inferiority against the current standard of care antibiotic, vancomycin. Motif said iclaprim was nearly identical when compared to vancomycin. According to its data, the Motif drug demonstrated a 78 percent clinical cure in patients, slightly edging out those patients taking vanomycin. Within 48 to 72 hours of dosing, patients saw a greater than 20 percent reduction in lesion area, Motif said. Motif trial data shows that 54.6 percent of patients receiving iclaprim demonstrated resolution or near resolution at end of therapy (EOT), compared to 55.4 percent of patients receiving vancomycin.
Last year Motif’s iclaprim was granted Orphan Drug Designation for the treatment of staphylococcus aureus lung infections in patients with cystic fibrosis. Iclaprim has also received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track Designation. Upon acceptance of the filing of the NDA by the FDA, iclaprim will receive Priority Review, a review period of six months instead of the standard ten months, the company said.
Shares of Motif closed at $8.58 on Thursday, up from its opening price of $8.41.
