Cempra Presents Data on Ophthalmic Solithromycin at ARVO
May 10 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 two abstracts highlighting topical ophthalmic
formulations of solithromycin in preclinical models of activity,
tolerability and pharmacokinetics (PK) in the eye at the annual
meeting of the Association for Research in Vision and Ophthalmology
(ARVO) in Baltimore, MD.
In one study, several formulations of 1%
solithromycin ophthalmic solution were developed and screened in
preclinical models to assess tolerability, and to evaluate
achievement of desired PK parameters for an ophthalmic
solution. Researchers found solithromycin ophthalmic solution
to achieve appropriate concentrations in ocular and periocular
tissues, and to be well tolerated with no signs of ocular redness,
discomfort or irritation.
Clinically relevant concentrations of
solithromycin were measured in multiple areas of the eye after a
single topical dose while systemic plasma concentrations remained
very low, regardless of the evaluated formulation.
In the other study, researchers assessed the
effect of solithromycin on meibomian gland epithelial cells.
Meibomian glands, which are found in the eyelids, secrete the lipid
layer that protects the ocular tear film from becoming dry.
Meibomian gland dysfunction is an important cause of dry eye
disease.
Researchers found that solithromycin induced a
rapid and dose dependent increase in healthy secretions from human
meibomian gland epithelial cells, in vitro. This response was seen
more rapidly than a similar effect observed with azithromycin in
the same cell culture system.
“It is possible that solithromycin, by acting
directly on human meibomian gland epithelial cells, may serve as an
important treatment for human meibomian gland dysfunction and its
associated dry eye disease,” said David Sullivan, M.D., senior
scientist and Margaret S. Sinon scholar in ocular surface research
at Schepens Eye Research Institute and associate professor of
ophthalmology at Harvard Medical School.
“These supportive data on potential formulations
for ophthalmic solithromycin and its additional potential activity
in dry eye are important as we continue to progress ophthalmic
solithromycin towards an IND,” said David Oldach, M.D., chief
medical officer of Cempra.
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'
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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