Cempra, Inc. (CEMP) has two pipeline candidates: solithromycin and Taksta. Solithromycin is being developed for the treatment of community-acquired bacterial pneumonia (:CABP) and gonorrhea. Taksta is being developed for the treatment of patients with prosthetic joint infections.
Cempra recently initiated a phase III trial on antibiotic candidate solithromycin. Enrollment started in Dec 2012. The double-blind, placebo-controlled and global multi-center trial (n=800) will evaluate the safety and efficacy of the oral form of solithromycin. Cempra expects to report top-line data from this study in mid-2014.
We note that Cempra is developing oral capsules, intravenous formulation and a pediatric suspension for potential use in all age groups. Cempra has an exclusive license and development agreement for solithromycin with a Japanese company, Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corp. (FUJIY).
Meanwhile, Cempra reported initial results from a phase II trial on Taksta. The study was designed to evaluate Taksta compared to the standard of care in patients with prosthetic joint infections. Patients were randomized to receive either oral Taksta in combination with Rifadin or current standard of care.
The primary endpoint was infection-free status at 12 weeks following initiation of therapy. Till date, 31 subjects were screened, of which 21 subjects were enrolled on Taksta plus rifampin. Out of 21, 13 patients were dropped from the study for various reasons including not growing a positive culture.
The remaining eight subjects were randomized into the trial. Only one subject has achieved success at re-implantation with a negative culture till date. Even though a small number of patients completed the trial, Cempra expects the study to lay the base for a defined phase III study.
We remind investors that Taksta was granted orphan drug designation by the U.S. Food and Drug Administration (:FDA) in Oct 2013. The designation will allow a 50% clinical cost tax credit and a PDUFA fee waiver along with seven years statutory market exclusivity.
Cempra had designed a phase III study for Taksta and expects the study to pave way for the application of a New Drug Application (:NDA). The company plans to submit its proposed phase III study protocol to the FDA early 2014 and thereafter discuss the same with the FDA in the first half of 2014.