Phase III Trial Success for Motif Bio’s Iclaprim
Motif Bio Explodes After Phase III Clinical Trial Success
October 4, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Shares of Motif Bio plc are soaring more than 22 percent this morning after the company’s Phase III drug candidate iclaprim hit primary endpoints in treating patients with acute bacterial skin and skin structure infections (ABSSSI).
Iclaprim is an investigational antibiotic. In the Phase III Revive-2 study, iclaprim achieved the primary endpoint of non-inferiority against the current standard of care antibiotic, vancomycin. In its announcement, 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 legion 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.
Iclaprim was well tolerated in the study, with most adverse events categorized as mild, the company said.
Revive-2 data was certainly enough of an incentive for investors to take action. Share prices have continued to rise following the opening of the market. Motif Bio stocks hit a morning high of $13.26 before settling back a bit to $12.35 as of 10:49 a.m.
Motif Chief Executive Officer Graham Lumsden said the data from Revive-2 along with positive data from another Phase III ABSSSI trial is strong enough to support a New Drug Application with the U.S. Food and Drug Administration. Lumsden said the company will seek regulatory approval by the end of the first quarter of 2018.
“We believe that iclaprim, if approved, could be an important option for patients with ABSSSI, especially for those patients who may also have kidney disease, with or without diabetes. It is estimated that up to 26 percent of the 3.6 million ABSSSI patients hospitalized annually in the U.S. have kidney disease,” Lumsden said in a statement. “Unlike current standard of care antibiotics, in clinical trials to date, kidney toxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment. 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, including MRSA.”
In September, Motif’s iclaprim was granted Orphan Drug Designation for the treatment of staphylococcus aureus lung infections in patients with cystic fibrosis.
This will not be the first time iclaprim has gone to the FDA. Writing in Endpoints News, John Carroll said iclaprim was taken to the regulatory agency in 2009 by Arpida AG, but was rejected due to safety issues.