Motif Bio plc's phase 3 study of iclaprim for acute bacterial skin and skin structure infections, or ABSSSI, met its primary goal.
The investigational antibiotic worked as well as the current standard of care vancomycin in treating the disease.
Iclaprim was well tolerated in the REVIVE-2 trial, with most adverse events categorized as mild. Of the total, 5.4% in the iclaprim arm of the study experienced treatment-related adverse events leading to discontinuation compared to 4.7% for those on vancomycin.
"Iclaprim may be an important option for the growing population of patients with ABSSSI and kidney disease who need a safe and effective antibiotic targeting Gram-positive bacteria," Motif Bio CEO Graham Lumsden said.
REVIVE-2 was the second of two phase 3 trials required for the drug to pursue regulatory approval.
The company plans to submit a new drug application for iclaprim to the U.S. Food and Drug Administration by the end of the first quarter of 2018.
If approved, iclaprim is expected to be eligible to receive 10 years of market exclusivity in the U.S. from the date of approval, the company said.