Following FDA debacle in ’09, Motif lines up a new shot at approval for antibiotic iclaprim
Eight years after the FDA and its experts slapped down Arpida’s antibiotic iclaprim, fearful that the treatment was unsafe to use and the efficacy case was dodgy at best, it’s about to be resubmitted after researchers today heralded a successful non-inferiority Phase III study comparing it favorably with vancomycin.
The news triggered a sharp spike for Motif’s share price $MTFB, which used this antibiotic to jump into late-stage development and Nasdaq.
Researchers say that the antibiotic hit the primary endpoint, with a near match in early clinical response. They also tracked a 78% clinical cure rate among patients with acute bacterial skin and skin structure infections compared to 77.7% in the vancomycin standard of care group.
That will set up a new application at the FDA in Q1 2018, where Motif will be looking to come out on top after its predecessors at Arpida had failed badly.
Arpida, a Roche spinout, had taken its Phase III data to regulators in 2009, but was handed its walking papers after an outside panel voted overwhelmingly against an approval, noting that evidence of QT prolongation and a disproportionate number of deaths in the iclaprim arm should preclude any further work on the antibiotic.
The setback scuttled Arpida. But before the company was bought out by Evolva, icalprim was spun out to a company called Nuprim, which the wikipedia page for the antibiotic says was created by an executive at Arpida. Then Motif, looking to switch into late-stage development, picked it up before going public.
The F-1 for their IPO notes that Khalid Islam, the former CEO at Arpida, was a minority shareholder in Motif.