The FDA is forcing a small antibiotic player back to the clinic for a new trial — 10 years after first rejection
Motif Bio $MTFB got a clear enough answer from the FDA on what regulators will need to see before they reconsider an OK on their antibiotic iclaprim. And it’s not what their dwindling band of investors wanted to hear.
The little biotech confidently reported Thursday morning that the FDA is requiring another clinical trial to clear up its stubborn concerns about the potential for liver toxicity — a worst case scenario that will once again significantly delay a program that has been trying to make a comeback at the agency for the past decade.
CEO Graham Lumsden says they’ll now be going back to the FDA to define the size of the trial needed, so they can go about budgeting for it.
“(W)e expect to continue our discussions with potential commercial partners and will determine the best options for funding the trial once we have clarity from the FDA,” he added in a prepared statement.
That’s a tall order for a company that built its stock price up past the $10 mark on confident expectations of winning an OK for acute bacterial skin and skin structure infections, or ABSSSI, and rolling it out into the market. This morning the already battered and bruised stock suffered a fresh 41% plunge as they moved down closer to the $1 mark.
The overall drop has erased about 90% of its share value over the past few months.
The antibiotic has been hobbled by safety concerns for years. The FDA punted back the original application from Roche spinout Arpida 10 years ago, citing an imbalance in deaths as well as QT prolongation. And now little Motif, which has signaled it’s running out of cash, will try to do a deal or raise money with its back against the wall.
Antibiotics, in general, have suffered a number of rejections at the hands of the FDA in recent years. And those that do get past regulators face a cruel market, where cheap generics dominate.
Image: Andrew Harnik AP