Eight Presentations at ASM Microbe Include Late Breaker From Cempra’s Phase 3 Fusidic Acid Study and Solithromycin Data on ...
June 02 2017 - 07:15AM
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
that researchers will present data from eight studies of fusidic
acid and solithromycin at the American Society for Microbiology
(ASM) 2017 meeting in New Orleans, LA.
“We are pleased that ASM has recognized data
informing important potential uses of solithromycin and fusidic
acid with two late breakers and eight overall presentations at the
conference,” said David Oldach, M.D., chief medical officer of
Cempra.
Cempra’s presentations at ASM Microbe consist
of:
- Comparison of the Efficacy of Solithromycin (SOLI) and
Moxifloxacin (MOXI) in Patients with Community-Acquired Bacterial
Pneumonia (CABP) Due to Haemophilus Influenzae(Friday,
June 2, 12:45p-2:45p CT, Poster Session 035, Exhibit Hall D, Poster
Number: 27)
- Results of a Phase 3 Trial Comparing Oral Sodium
Fusidate (Fusidic Acid) versus Oral Linezolid for Treatment of
Acute Bacterial Skin and Skin Structure Infections
(ABSSSI)(Saturday, June 3, 12:15p-2:15p CT, Late Breaker
Session 181a, Exhibit Hall D, Poster Number: LB21)
- Phospholipidosis and its Reversal Induced by
Solithromycin (SOL) and its Main Animal Metabolites
(N-Acetyl-Solithromycin [NAS] and
Des-Aminophenyltriazol-Hydroxy-Solithromycin [CEM-214]): Studies
with Cultured Rat Fibroblasts(Sunday, June 4, 12:15p-2:15p
CT, Poster Session 341, Exhibit Hall D, Poster Number: 196)
- Results of the SOLITAIRE-U Phase 3 Trial Comparing
Single Dose Oral Solithromycin versus Single Dose Intramuscular
Ceftriaxone plus Single Dose Oral Azithromycin for Treatment of
Uncomplicated Urogenital Gonorrhea(Sunday, June 4,
12:15p-2:15p CT, Late Breaker Session 334a, Exhibit Hall D, Poster
Number: LB35)
In addition, Toyama, Cempra’s partner for
solithromycin in Japan, and JMI Laboratories, an independent
laboratory conducting work supported by Cempra, will present the
following abstracts:
- Antibacterial Activity of Solithromycin
(CEM-101/T-4288) and Comparators against Clinical Isolates of
Streptococcus pneumoniae, Streptococcus pyogenes, and Haemophilus
influenza Isolated in Japan(Friday, June 2, 12:45p-2:45p
CT, Poster Session 039, Exhibit Hall D, Poster Number: 127)
- Activity of Fusidic Acid against Recent Clinical
Isolates of Staphylococci Collected from United States Hospitals in
2016 as Part of the SENTRY Antimicrobial Surveillance
Program (Saturday, June 3, 12:15p-2:15p CT, Poster
Session 185, Exhibit Hall D, Poster Number: 56)
- Pharmacokinetic-Pharmacodynamic Target Attainment
Analyses to Evaluate Clinical Effect of Solithromycin
(CEM-101/T-4288) for Acute Otitis Media(Sunday, June 4,
12:15p-2:15p CT, Poster Session 341, Exhibit Hall D, Poster Number:
195)
- Activity of Solithromycin and Comparators against
Respiratory Tract Pathogens Collected in the 2016
Global SENTRY Surveillance Program(Sunday, June 4,
12:15p-2:15p CT, Poster Session 335, Exhibit Hall D, Poster Number:
7)
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. (Toyama), 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'
preclinical 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.
Contact:
John Bluth
Cempra, Inc.
(984) 209-4534
jbluth@cempra.com
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