Pipeline Progress at Cempra - Analyst Blog
19 Décembre 2013 - 12:00AM
Zacks
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.
Cempra carries a Zacks Rank #4 (Sell). Currently, companies
which look well-positioned include Actelion Ltd.
(ALIOF) and Jazz Pharmaceuticals (JAZZ). Both
carry a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
CEMPRA INC (CEMP): Free Stock Analysis Report
FUJIFILM HLDGS (FUJIY): Free Stock Analysis Report
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report
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