Clinical-stage pharmaceutical company Cempra has commenced a Phase III trial of its orally-administered fluoroketolide antibiotic candidate, solithromycin, designed to treat patients with community-acquired bacterial pneumonia (CABP).
The double-blind, global multi-centre and placebo-controlled study, which is expected to be completed in the first half of 2014, will enrol approximately 800 patients with PORT-II to PORT-IV CABP.
Patients will be randomised to receive either oral solithromycin, an 800mg loading dose followed by 400mg once daily for a total of five days, or once-daily oral administration of 400mg of moxifloxicin for seven days.
Non-inferiority of early response at 72 hours, as specified by the proposed FDA guidance, will be the primary endpoint of the study.
Combination therapy with intravenous antibiotics or oral administration of fluoroquinolone antibiotics is the current therapy for moderate to moderately-severe CABP, according to the company’s president and CEO Prabhavathi Fernandes.
The former involves intravenous therapy, possibly requiring hospital admission and the latter has been associated with significant side effects, possibly including Clostridium difficile infection due to the class’s broad activity spectrum.
Fernandes said the oral drug has also shown a favourable safety profile in over 400 patients, including when compared to levofloxacin in a Phase II trial in CABP patients.
"The compound may offer both flexibility and convenience as it is in development for both oral and intravenous formulations," Fernandes added.
"The drug may provide the option of IV-to-oral step down monotherapy to send patients home from the hospital sooner. In addition, and as this clinical trial may demonstrate, patients may be able to avoid hospital admission by starting on the oral form as monotherapy."