Cempra Presents Data at ECCMID Highlighting Need for New CABP Therapies and Activity of Solithromycin in Key Population Group...
April 21 2017 - 7:00AM
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company
focused on developing antibiotics to meet critical medical needs in
the treatment of bacterial infectious diseases, today announced the
company is presenting eight abstracts highlighting solithromycin
and the need for new treatments for community-acquired bacterial
pneumonia (CABP) at the 27th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria.
“As we continue to analyze data from our
solithromycin trials, a pattern of activity across pathogens,
geographies and patient types continues to emerge,” said David
Oldach, M.D., chief medical officer of Cempra.
“Considering the documented risks associated
with fluoroquinolone treatment, and the correlation between
treatment failure and mortality, patients and physicians would
benefit greatly from new safe and effective antibiotic treatment
options for CABP,” Oldach added.
Cempra’s presentations at ECCMID consist of:
- Characterization of Streptococcus Pneumoniae from the
Solithromycin Global Clinical Trial Programme in Community Acquired
Pneumonia (Saturday, April 22, 3:30p-4:30p CET,
Abstract Number: 7072)
- Efficacy of Solithromycin versus Moxifloxacin in the
Treatment of CABP by Baseline PORT Risk Class: Results from Two
Large, Multi-National Studies (Monday, April 24,
12:30p-1:30p CET, Abstract Number: 6890)
- Efficacy of Solithromycin for Treatment of
Community-Acquired Pneumonia by Patient Age: Pooled Analysis of Two
Multinational, Double-Blind, Randomized, Controlled
Studies (Monday, April 24, 12:30p-1:30p CET, Abstract
Number: 6970)
- Early Clinical Response (ECR) of Solithromycin Compared
with Moxifloxacin in Microbiologically Positive Subjects from Two
Global Clinical Trials in Community-Acquired Bacterial
Pneumonia (Monday, April 24, 12:30p-1:30p CET, Abstract
Number: 6985)
- Multi-National Studies Comparing Solithromycin, a New
Macrolide, to Moxifloxacin in the Treatment of CABP: Response by
Geographical Region (Monday, April 24, 12:30p-1:30p
CET, Abstract Number: 7001)
- Evaluation of Early Clinical Response as a Primary
Endpoint for CABP: Pooled Analysis of Phase 3 Studies Comparing
Solithromycin, a New Macrolide, and
Moxifloxacin (Monday, April 24, 12:30p-1:30p CET,
Abstract Number: 7024)
- Relationship Between Antibiotic Treatment Failure and
30-Day Mortality in Adult Outpatients with Community-Acquired
Pneumonia (Tuesday, April 25, 2:18p-2:28p CET,
Abstract Number: 1178—Oral Presentation)
- Adverse Events Associated with Fluoroquinolone and
Macrolide Therapy in Adult Outpatients Treated for
Community-Acquired Pneumonia (Tuesday, April 25,
2:42p-2:52p CET, Abstract Number: 3924—Oral Presentation)
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical
company focused on developing differentiated anti-infectives for
acute care and community settings to meet critical medical needs in
the treatment of infectious diseases. Cempra's two lead product
candidates are currently in advanced clinical development.
Solithromycin has been evaluated in two phase 3 clinical trials for
community-acquired bacterial pneumonia (CABP). Cempra is currently
seeking approval for CABP for both intravenous and oral capsule
formulations from the U.S. Food and Drug Administration.
Solithromycin is licensed to strategic commercial partner Toyama
Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation,
for certain exclusive rights in Japan. Cempra is contracted with
BARDA for the development of solithromycin for pediatric use and
has commenced enrollment in a global Phase 2/3 trial to evaluate
the safety and efficacy of solithromycin versus standard of care
antibiotics in children and adolescents from two months to 17 years
of age. Solithromycin is also in development for uncomplicated
urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia.
Fusidic acid is Cempra's second product candidate, which has
completed a phase 3 trial comparing fusidic acid to linezolid in
patients with acute bacterial skin and skin structure infections
(ABSSSI). Cempra also has an ongoing exploratory study of fusidic
acid for chronic oral treatment of refractory infections in bones
and joints. Both products seek to address the need for new
treatments targeting drug-resistant bacterial infections in the
hospital and in the community. Cempra is also studying
solithromycin for ophthalmic conditions and has synthesized novel
macrolides for non-antibiotic uses such as the treatment of chronic
inflammatory diseases, endocrine diseases and gastric motility
disorders. Cempra was founded in 2006 and is headquartered in
Chapel Hill, N.C. For additional information about Cempra please
visit 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: results of our and our strategic commercial partners'
pre-clinical studies and clinical trials are not predictive of
results from subsequent clinical trials for any possible therapy;
our ability to obtain FDA and foreign regulatory approval of
solithromycin as a treatment for community acquired bacterial
pneumonia; our dependence on the success of solithromycin and
fusidic acid; our and our strategic commercial partners' ability to
obtain FDA and foreign regulatory approval of our product
candidates; the costs, sources of funds, enrollment, timing,
regulatory review and results of our studies and clinical trials
and those of our strategic commercial partners; the
unpredictability of the size of the markets for, and market
acceptance of, any of our products, including solithromycin and
fusidic acid; our ability to commercialize and launch, whether on
our own or with a strategic partner, any product candidate that
receives regulatory approval; our ability to produce and sell any
approved products and the price we are able to realize for those
products; innovation by our competitors; and our ability to stay
abreast of and comply with new or modified laws and regulations
that currently apply or become applicable to our business. The
reader is referred to the documents that we file from time to time
with the Securities and Exchange Commission.
John Bluth
Cempra, Inc.
(984) 209-4534
jbluth@cempra.com
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