—More than 20 percent of adult CABP patients failed initial antibiotic monotherapy, including approximately one of four elderly patients—
—Average U.S. macrolide resistance to S. pneumoniae approximately 49 percent; greater than 60 percent in some regions—
CHAPEL HILL, N.C., Oct. 04, 2016 (GLOBE NEWSWIRE) -- 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 presentation of three abstracts based upon analyzing treatment failures with existing antibiotics from more than 400,000 records of patients diagnosed with community-acquired bacterial pneumonia (CABP) in a large U.S. insurance claims database.
The data analysis will be presented at the annual Academy of Managed Care Pharmacy Nexus meeting in National Harbor, MD from October 3-6, 2016.
These patient records were analyzed to assess rates of failure to the most commonly prescribed antibiotics to treat CABP. Treatment failure was defined as antibiotic prescription refill, new antibiotic claim, emergency room visit, or hospitalization occurring within 30 days of initial therapy.
This analysis showed that more than one out of five adult CABP patients failed initial antibiotic monotherapy, with the failure rate exceeding one out of four for an elderly population with certain comorbidities.
In a separate analysis of the same database, an association was observed between macrolide-resistant S. pneumoniae, the most common cause of CABP, and macrolide treatment failure by region in the U.S., with the frequency of macrolide-resistant S. pneumoniae as high as 64 percent in the West South Central region of the U.S. Nationwide, the average frequency of macrolide-resistant S. pneumoniae was approximately 49 percent.
“These data, showing a high level of macrolide resistance and a high level of treatment failure with the most commonly used antibiotics in CABP, highlight the urgent need for new treatment options for CABP,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.
An additional analysis of more than 150,000 patient records from children under age 18 with a CABP diagnosis identified significant treatment failure rates for the primary classes of antibiotics prescribed for CABP in children.
The three accepted abstracts will be presented during the meeting’s designated poster sessions.
- Poster J03: The relationship between macrolide-resistant Streptococcus pneumoniae and treatment failure in adults with community-acquired bacterial pneumonia by CDC Region in the USA
Authors: Classi P2, Landsman-Blumberg P1, Carroll C1, Murty S1 , Slaff S1, Lopatkin A3, Tillotson G2; 1—Xcenda LLC., Real-World Evidence; 2—Cempra, Inc.; 3—Duke University and Cempra Inc.
Poster Session: Diseases of the Respiratory System
Date/Time: Tuesday, October 4, 4:00 – 6:00 pm ET
Location: Exhibit Hall
- Poster J05: Antibiotic treatment failure in adults with community-acquired bacterial pneumonia: an analysis of a large U.S. claims database
Authors: Landsman-Blumberg P1, Carroll C1, Murty S1, Slaff S1, Classi P2, Lopatkin A3, Tillotson G2; 1—Xcenda LLC., Real-World Evidence; 2—Cempra, Inc.; 3—Duke University and Cempra Inc.
Poster Session: Diseases of the Respiratory System
Date/Time: Tuesday, October 4, 4:00 – 6:00 pm ET
Location: Exhibit Hall
- Poster J04: Patterns of antibiotic treatment failure in pediatric community-acquired bacterial pneumonia in the USA
Authors: Lopatkin A3, Classi P2, Landsman-Blumberg P1, Carroll C1, Murty S1, Slaff S1, Tillotson G2; 1—Xcenda LLC., Real-World Evidence; 2—Cempra, Inc.; 3—Duke University and Cempra, Inc.
Poster Session: Diseases of the Respiratory System
Date/Time: Tuesday, October 4, 4:00 – 6:00 pm ET
Location: Exhibit Hall
About Cempra, Inc.
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 has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP) and applications for approval for both intravenous and oral capsule formulations have been accepted for review by the FDA and the EMA. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a Phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use. Three formulations, intravenous, oral capsules and a suspension formulation are in a Phase 1b trial in children from birth to 17 years of age. Fusidic acid is Cempra's second product candidate, which is being developed for acute bacterial skin and skin structure Infections (ABSSSI) and is also in an exploratory study 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 has also 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 pre-clinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates, including solithromycin; 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; our ability to retain and hire necessary employees and to staff our operations appropriately; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; 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; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our ability to compete in our industry; our dependence on the success of solithromycin and fusidic acid; 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.