Cempra’s Q4 review today includes a slate of new setbacks, ranging from a failure for a Phase III non-inferiority trial of its antibiotic solithromycin in gonorrhea to an early end of an exploratory study in NASH as well as a decision to shutter a trial in COPD based on safety concerns. And with the fate of its lead program up in the air, the biotech followed up with a top-to-bottom restructuring, slashing most of its payroll as it sought to conserve cash.
The biotech is cutting 67% of its workforce, dropping from 136 to 45 employees with “significant reductions in external spending related to commercial preparedness and non-essential activities,” Cempra reported. “The principal objective of the reductions is to enable us to conserve our financial resources as we evaluate the best path forward with our existing pipeline and potential business development opportunities.”
Following closely on the heels of a successful head-to-head Phase III matchup of its oral antibiotic fusidic acid against an old standby, investors were reminded once again why solithromycin has been such a huge disappointment, earning a rejection by the FDA last December based on safety fears.
The biotech’s shares $CEMP turned south again, dropping 20% by mid-morning.
Its quarterly update today included:
While solithromycin demonstrated high success rates of 80.5 percent in the microbiological intent to treat (mITT) population (defined as achievement of a negative urethral or cervical swab culture at day seven to eight among those patients who had culture confirmation of GC infection at baseline) and 91.3 percent in the microbiologically evaluable (ME) population (comprised of those patients with a positive baseline culture who returned for their follow-up evaluation), and showed a 100 percent success rate for females in the ME population, solithromycin did not demonstrate non-inferiority (NI) to standard of care treatment given the pre-specified 10 percent NI margin in the mITT population. The success rates for CTX/AZI in the mITT and ME populations were 84.5 percent and 100 percent, respectively.
The company went on to say that “we believe that the small number of solithromycin treatment failures observed in SOLITAIRE-U could be reduced in an approval-enabling study with an adjustment to the dosing regimen, as we believe the treatment failures were most likely related to the duration of study drug exposure at the site of infection.”
They plan to talk it over with the FDA, which clearly has deep concerns about solithromycin. But they don’t plan to revisit NASH and COPD any time soon. In COPD, investigators raised a red flag over airway inflammation in patients, bringing up fresh concerns for an antibiotic already tied to liver toxicity.
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