Cempra, Inc. (CEMP) enrolled patients in SOLITAIRE-Oral, a phase 3 trial of lead antibiotic solithromycin, slightly faster than expected, announcing completion on Thursday that puts a top-line readout in community-acquired bacterial pneumonia (CABP) early next year. CEMP rallied 10% through morning trade given prior guidance for enrollment completion in the fourth quarter.
PropThink has written extensively on CEMP this year and last. You can read more by clicking here.
The phase 3 study is a double-blind, placebo-controlled trial that randomized 860 patients with PORT-II, PORT-III, or PORT-IV CABP to either oral solithromycin (800mg followed by 400mg once daily for 5 days) or seven days of once-daily moxifloxacin at 400mg. The primary endpoint in the trial is non-inferiority of early response at 72 hours. A second phase 3 study of solithromycin (SOLITAIRE-IV), testing an IV formulation stepped down to oral, is underway. Additionally, a phase 3 trial in uncomplicated gonorrhea (SOLITAIRE-U) began in August.
Yet this year, Cempra expects to initiate a NAIAD-funded urogenital solithromycin pharmacokinetics study and initiate dosing in an investigator-sponsored phase 2 study in COPD
Early this month, Cempra also announced the receipt of a $10 million milestone payment from Toyama Chemical Co., a subsidiary of FUJIFILM, triggered by Toyama’s progress with its solithromycin clinical development program in Japan. Cempra is entitled to an additional $50M over the course of the solithromycin development/regulatory program in Japan.
One or more of PropThink’s contributors are long CEMP.
