Solithromycin, the company’s fluoroketolide antibiotic candidate, is designed for treating patients with community-acquired bacterial pneumonia (CABP).
The study, which will enroll approximately 800 patients with PORT-II to PORT-IV CABP, will randomize patients to receive either oral solithromycin, an 800 mg loading dose followed by 400 mg once daily for a total of five days, or once-daily oral administration of 400 mg of moxifloxicin for seven days.
The primary endpoint of the study includes non-inferiority of early response at 72 hours, as specified by the proposed FDA guidance.
Combination therapy with intravenous antibiotics or oral administration of fluoroquinolone antibiotics are current therapy for moderate to moderately-severe CABP, according to the company’s chief executive officer (CEO).
Cempra president and CEO Prabhavathi Fernandes said the oral drug has also shown a favorable 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.