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Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired



   Cempra Provides Guidance on the Clinical Program Required for Regulatory
 Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)

FDA Proposes Qualified Pathogen List that Includes Pathogens, such as
Streptococcus pneumoniae, that are Susceptible to Solithromycin

PR Newswire

CHAPEL HILL, N.C., June 13, 2013

CHAPEL HILL, N.C., June 13, 2013 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP),
a clinical-stage pharmaceutical company focused on developing differentiated
antibiotics to meet critical medical needs in the treatment of bacterial
infections, today described the steps expected for regulatory approval for
solithromycin for community-acquired bacterial pneumonia (CABP).  This path
forward is a result of a dialogue and End-of-Phase 2 meeting with the Food and
Drug Administration (FDA).

"We believe our End-of-Phase 2 meeting with the FDA has provided us with clear
direction toward approval of solithromycin for CABP," said Prabhavathi
Fernandes, Ph.D., president and chief executive officer of Cempra.  "We were
pleased with the FDA input and believe we are in a position to proceed with
our second Phase 3 study and the rest of the clinical program, subject to
receipt of the necessary funding.  We know the requirements for the CABP
safety database and efficacy endpoints for NDA submission. In addition, we
received preliminary feedback on the trial design for the uncomplicated
gonococcal infection indication."

The Phase 3 solithromycin clinical program in CABP will be planned to consist
of an oral trial and an intravenous (IV)-to-oral clinical trial. Cempra
followed the CABP guidance that the FDA proposed in a November, 2011, meeting
of the Anti-Infective Drugs Advisory Committee. The FDA provided comments on
the Phase 3 oral CABP protocol in June, 2012, and this global study is
ongoing. This study compares five days of oral solithromycin with seven days
of oral moxifloxacin. FDA responses prior to and at the End-of-Phase 2 meeting
addressed the second Phase 3 study, which is the planned intravenous-to-oral
step-down trial.

In the IV-to-oral Phase 3 study, approximately 800 patients with Port II to
Port IV CABP will be randomized to either a 400 mg IV dose of solithromycin or
400 mg IV dose of moxifloxacin. The investigator will switch patients to oral
administration of the assigned antibiotic (solithromycin or moxifloxacin)
based on protocol-defined clinical criteria. Patients randomized to
solithromycin will receive an 800 mg loading dose on the first day of oral
administration followed by 400 mg once daily for a total of seven days of
treatment, while patients randomized to moxifloxacin will receive 400 mg once
daily for a total of seven days of treatment.

The primary outcome analysis in both Phase 3 trials is non-inferiority (NI) in
the early clinical response rates (ECR). ECR is defined as improvement at 72
hours after the first dose of study drug, in at least two of the following
four symptoms: cough, shortness of breath, chest pain and sputum production in
the Intent-To-Treat (ITT) population. Each study is designed to provide 90
percent power to demonstrate NI in ECR rates of solithromycin versus
moxifloxacin utilizing a 10 percent margin. A co-primary outcome analysis will
assess NI in ECR rates in the pooled microbiological ITT (mITT) population
from the two studies. Secondary endpoints include the clinical success rate at
the short-term follow-up visit five to ten days following the last dose of
study drug in the ITT and clinically evaluable populations, and a comparison
of safety and tolerability of solithromycin compared to moxifloxacin.

A single Phase 3 study of solithromycin in uncomplicated gonococcal infection
would likely be sufficient if the Phase 3 CABP trials are successful. This
study would be planned to include 250 patients who receive solithromycin, of
which 150 are males. Treatment of Chlamydia may be included as a secondary
endpoint. The specific protocol remains under discussion. 

On June 12, 2013, the FDA issued a proposed rule listing pathogens that would
be eligible for drug development incentives under the Generating Antibiotic
Incentives Now (GAIN) Act. The pathogens proposed for eligibility include
Campylobacter, Enterococcus, Neisseria gonorrhoeae, Streptococcus agalactiae,
Streptococcus pneumoniae, Streptococcus pyogenes, the Mycobacterium
tuberculosis complex of species and non-tuberculous Mycobacteria species.
Solithromycin has demonstrated activity against all of these pathogens.  There
can be no assurances that the FDA proposal, which is subject to a public
comment period, will become a final rule or that, if passed, the final rule
will include any or all of the above-mentioned pathogens.

About Cempra, Inc.
Founded in 2006, Cempra, Inc. is a clinical-stage pharmaceutical company
focused on developing antibiotics to meet critical medical needs in the
treatment of bacterial infectious diseases.  Cempra's two lead product
candidates are currently in advanced clinical development.  Solithromycin
(CEM-101) is in a Phase 3 clinical trial 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.  Both 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 FDA's
agreement with our planned studies and trials and the sufficiency of trial
results to support a New Drug Application; the results, timing, costs and
regulatory review of our studies and clinical trials; our need to obtain
additional funding and our ability to obtain future funding on acceptable
terms; regulatory rulemaking; our anticipated capital expenditures and our
estimates regarding our capital requirements; the results of studies of our
product candidates conducted by others; the possible impairment of, or
inability to obtain, intellectual property rights and the costs of obtaining
such rights from third parties; our ability to obtain FDA approval of our
product candidates; our dependence on the success of solithromycin and Taksta;
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.

Investor Contacts:
Robert E. Flamm, Ph.D.
Russo Partners, LLC
(212) 845-4226 
Robert.flamm@russopartnersllc.com

Andreas Marathovouniotis
Russo Partners, LLC
(212) 845-4235
Andreas.marathis@russopartnersllc.com

Media Contact:
Karine Kleinhaus, M.D.
Russo Partners, LLC
(646) 942-5632
Karine.kleinhaus@russopartnersllc.com

 

SOURCE Cempra, Inc.

Website: http://www.cempra.com
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