Just two months after taking a beating on the FDA’s decisive rejection of Cempra’s antibiotic solithromycin, the biotech has been redeemed by the success of a head-to-head Phase III matchup of its oral antibiotic fusidic acid against an old standby. Cempra’s shares $CEMP rocketed up 40% on the turnaround.
Overall, fusidic acid matched up favorably to linezolid among the 716 patients with acute bacterial skin and skin structure infections in the study, hitting its marks for non-inferiority and achieving the primary as well a secondary goals. Fusidic acid edged out linezolid among men and women, and matched up nicely for a range of infection types.
The safety profile also matched up well.
The results leave Chapel Hill, NC-based Cempra with a much better chance of success for this new antibiotic compared to solithromycin. Caught on the horns of a dilemma posed by clear evidence of liver toxicity and a growing demand for new antibiotics, the FDA decided to reject Cempra’s lead antibiotic late in December, demanding a large new safety study before reconsidering its position. And the agency flagged a warning that any future label will carefully restrict its use, which will damage its market potential.
Cempra’s spike today still leaves its stock trading at just a fraction of the peak in mid-2015.
Cempra is one of a handful of biotechs developing new antibiotics, despite a growing need for new weapons to disarm drug resistant infections.
“Considering complicated skin infections are one of the most rapidly growing reasons for hospitalizations and emergency department visits each year, the results with fusidic acid in this study are promising, especially for an outpatient population where there is a need for new oral drugs that are effective against MRSA,” said William O’Riordan, M.D., chief medical officer of eStudySite.
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