) 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.
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
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
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.
Cempra carries a Zacks Rank #4 (Sell). Currently, companies
which look well-positioned include
). Both carry a Zacks Rank #1 (Strong Buy).
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