Cempra Initiates Solithromycin Pediatric Program
First Patient Dosed in Biomedical Advanced Research and Development Authority
(BARDA)-Funded Phase 1 Study
CHAPEL HILL, N.C., Feb. 20, 2014 (GLOBE NEWSWIRE) -- Cempra, Inc.
(Nasdaq:CEMP) today announced the dosing of the first patient in its Phase 1
study of solithromycin capsules in children. The clinical trial is funded
through Cempra's contract with the Biomedical Advanced Research and
Development Authority (BARDA;
"This is a major step forward for the program and reflects the success of the
partnership between Cempra, BARDA, and Duke University," said Danny Benjamin,
M.D., Ph.D., M.P.H., professor of Pediatrics, and faculty associate director
of Duke Clinical Research Institute. "We believe that the partnership with
BARDA highlights the public health relevance of solithromycin. As far as we
are aware, this is BARDA's first pediatric program in community acquired
pneumonia. All of us at the Duke Clinical Research Institute are thrilled to
be a part of this important partnership."
Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra
added, "The running of this pediatric trial concurrently with our Phase 3
program in adult CABP is almost unprecedented and highlights both the serious
need for new oral antibiotics for children as well as the favorable safety
profile of solithromycin to date. There have been no new oral antibiotics for
children in almost 25 years. Cempra plans to study all solithromycin dosage
forms in the pediatric age groups. Importantly, this should provide dosing
flexibility for children of all age groups under the care of a pediatrician."
Community-acquired bacterial pneumonia is a significant cause for childhood
Resistance to antibiotics currently used to treat CABP has increased
options are needed, particularly orally-administered antibiotics, which may
prevent or reduce the length of hospitalization.
The first part of the Phase 1 clinical trial
will enroll pediatric patients between the ages of 12 to 17 years with
suspected or confirmed bacterial infections. Each patient will receive
solithromycin capsules for up to five days as add-on therapy. Following this
study the Phase 1 study will continue, utilizing the oral suspension
formulation which will be tested in younger age groups down to newborn. The
intravenous formulation will also be studied in all pediatric age groups. The
study will generate safety and pharmacokinetic data of solithromycin in
pediatric patients. Cempra and the Food and Drug Administration have agreed to
a Pediatric Study Plan (PSP) and Cempra has submitted a Pediatric
Investigational Plan (PIP) to the European Medicines Agency.
Solithromycin is Cempra's fourth-generation macrolide and the first
fluoroketolide with potential for broad use, including in pediatrics.
Macrolides, as a class have been known for their safety and efficacy and thus
have traditionally been among the most prescribed antibiotics in pediatrics.
Cempra is developing oral capsules, an intravenous formulation and a pediatric
suspension to provide dosing flexibility for all age groups, both in the
hospital as well as in outpatient use. Solithromycin is the first antibiotic
in almost 25 years being developed in dosing formulations suitable for all
populations from babies to adults.
About Cempra, Inc.
Founded in 2006, Cempra, Inc. is a late clinical-stage pharmaceutical company
focused on developing antibiotics to treat critical bacterial infections in
patients in both acute and primary care settings. Cempra's two lead product
candidates are currently in advanced clinical development. Solithromycin
(CEM-101) is in two Phase 3 clinical trials for community-acquired bacterial
pneumonia (CABP) and is licensed to strategic commercial partner Toyama
Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain
exclusive rights in Japan. TAKSTA™ (CEM-102) is Cempra's second product
candidate currently in a Phase 2 clinical trial for prosthetic joint
infections. TAKSTA was recently granted orphan drug designation for this
indication. Both product candidates seek to address the need for new
treatments targeting drug-resistant bacterial infections in the hospital and
in the community. The company also intends to use its series of proprietary
lead compounds from its novel macrolide library for uses such as the treatment
of chronic inflammatory diseases, endocrine diseases and gastric motility
disorders. Additional information about Cempra can be found at www.cempra.com.
Please Note: This press release contains forward-looking statements regarding
future events. These statements are just predictions and are subject to risks
and uncertainties that could cause the actual events or results to differ
materially. These risks and uncertainties include, among others: the results,
timing, costs and regulatory review of our studies and clinical trials; the
results of studies of our product candidates conducted by others; our need to
obtain additional funding and our ability to obtain future funding on
acceptable terms; our anticipated capital expenditures and our estimates
regarding our capital requirements; our ability to obtain FDA approval of our
product candidates; our dependence on the success of solithromycin and Taksta;
the possible impairment of, or inability to obtain, intellectual property
rights and the costs of obtaining such rights from third parties; and
innovation by our competitors. The reader is referred to the documents that we
file from time to time with the Securities and Exchange Commission.
CONTACT: Investor and Media Contacts:
Robert E. Flamm, Ph.D.
Russo Partners, LLC
Russo Partners LLC
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