CHAPEL HILL, N.C., May 19, 2015 (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, is presenting results from its Phase 3 clinical trial demonstrating the statistical non-inferiority of oral solithromycin versus oral moxifloxacin for the treatment of community acquired bacterial pneumonia (CABP). Oral solithromycin demonstrated statistical non-inferiority to oral moxifloxacin for the treatment of CABP and the solithromycin early clinical response (ECR) and short term follow-up (SFU) rates were numerically higher than moxifloxacin in the elderly, the patients at greatest risk for CABP. Solithromycin was non-inferior to moxifloxacin on every pre-specified outcome measure in the study. These results will be presented at the American Thoracic Society (ATS) International Conference 2015 at 9:30 a.m. MDT (11:30 a.m. EDT) today in Denver.
"This landmark study has demonstrated non-inferiority for solithromycin versus moxifloxacin for all of the primary and secondary endpoints and is the first Phase 3 oral antibiotic study to be conducted using the new FDA CABP guidance in an outpatient setting," stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We believe it is critically important to provide physicians who treat CABP with an oral therapy that could potentially be used in both the hospital and community setting. Our global Phase 3 CABP trial evaluating IV to oral solithromycin versus IV to oral moxifloxacin is on-going and we expect to announce top line results by the end of 2015."
Phase 3 Trial Design and Key Results
- The study consisted of a 1:1 randomization of 860 CABP patients to oral solithromycin for 5 days or oral moxifloxacin for 7 days, stratified by geographic region, by history of asthma and/or chronic obstructive pulmonary disease (COPD), and by PORT score (II vs. III/IV). PORT II severity pneumonia was capped in the study at 50%. The primary endpoint (for FDA) was non-inferiority (NI) in ECR rate at 72 hours in the intent-to-treat (ITT) population. The primary endpoint (for EMA) was NI in success rate at SFU visit, 5 to 10 days after end of therapy in the ITT and clinically-evaluable (CE) populations.
- Patients randomized to solithromycin received an 800 mg loading dose on day 1, 400 mg on days 2-5 and placebo on days 6 and 7. Patients in the moxifloxacin treatment arm received 400 mg on days 1-7.
- Oral solithromycin demonstrated statistical non-inferiority to oral moxifloxacin for the treatment of CABP with a treatment success rate in the ECR-ITT population of 78.2% for solithromycin and 77.9% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper bounds of -5.5% and 6.1%, respectively. Notably, solithromycin ECR rates were numerically higher than moxifloxacin in patients over 75 years of age with a treatment success rate of 83.9% for solithromycin and 69.8% for moxifloxacin. The 95% confidence interval for the treatment success rate in this age group had lower and upper bounds of -2.1 and 30.2, respectively. In addition, oral solithromycin demonstrated NI for the SFU-ITT endpoint with a success rate of 84.5% for solithromycin and 86.6% for moxifloxacin with a 95% confidence interval for the treatment difference at lower and upper bounds of -7.1 and 2.8, respectively.
- Treatment emergent adverse events were comparable for the two patient groups with 155 (36.6%) reported for solithromycin and 154 (35.6%) for moxifloxacin. There were no serious adverse events attributed to solithromycin. There were more Grade 4 ALT elevations among patients who received moxifloxacin (1.2%) compared to solithromycin (0.5%). In addition, there were two cases of C. difficile infection, both of which occurred in the moxifloxacin group.
About Community Acquired Bacterial Pneumonia (CABP)
Community-acquired bacterial pneumonia is the number one cause of death from an infection, particularly in the very young and in the elderly. CABP is one of the most commonly diagnosed bacterial infections in the U.S. resulting in 5 to 10 million cases per year. Although many strains of the primary CABP pathogen, Streptococcus pneumoniae, are resistant to currently-approved macrolides, this class of antibiotic remains among the most commonly prescribed antibacterial drugs for CABP in both the hospital and community settings. Due to the rising threat of microbial resistance, along with concerns over antibiotic tolerability and impact on intestinal microflora, new CABP treatments are needed. Antibiotic resistance is a complex, emerging problem globally with potentially devastating consequences for public health.
Solithromycin is a highly potent next-generation macrolide, the first fluoroketolide, which has potent activity against most macrolide-resistant strains. In vitro and in vivo studies have shown potent activity against S. pneumoniae as well as an extended spectrum of activity against CA-MRSA, streptococci, Haemophilus, enterococci, Mycobacterium avium and in animal models of malaria. It is also active against atypical bacteria, such as legionella, chlamydia, mycoplasma and ureaplasma, and against gonococci and other organisms that cause genitourinary tract infections. It is 8-16 times more potent than azithromycin and is active against azithromycin-resistant strains. Solithromycin's activity against resistant strains is driven by its ability to interact with three sites on the bacterial ribosome, compared to one for current macrolides. The binding to three ribosomal sites is expected to limit resistance development.
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 (CEM-101) is in Phase 3 clinical development 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. Solithromycin has also entered a Phase 3 clinical trial for uncomplicated bacterial urethritis caused by Neisseria gonorrhoeae and chlamydia. Taksta™ (CEM-102) is Cempra's second product candidate, which is being developed 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. The company 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: the costs, sources of funds, 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; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and Taksta; 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; our ability to compete in our industry; our dependence on the success of solithromycin and Taksta; 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.
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