Solithromycin met primary and secondary objectives of non-inferiority compared to moxifloxacin, a potent fluoroquinolone
Cempra plans to complete a New Drug Application (NDA) submission to the FDA for the treatment of CABP during the first half of 2016
The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP
CHAPEL HILL, N.C., Feb. 05, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics in the face of rising antibiotic resistant bacterial infections, today announced the publication of positive results from its pivotal Phase 3 clinical trial of solithromycin oral capsules in the treatment of patients with community-acquired bacterial pneumonia (CABP) in The Lancet Infectious Diseases. The article, titled, “Efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of community-acquired bacterial pneumonia: a global, double-blind, multi-centre, randomized, active-controlled, non-inferiority trial (SOLITAIRE-ORAL)” appears in the February 4th online issue and will be published in a future print issue of the journal.
“Pneumonia remains a top ten cause of death in the U.S. and is the leading cause of death from infectious disease in most developed countriesi. The management of CABP is challenged by increasing antimicrobial resistance, which is approaching 50 percent in the U.S.ii,” said Carlos M. Barrera, M.D., principal investigator and a pulmonologist and endocrinologist at Baptist Hospital of Miami. “The results of this study are exciting because solithromycin demonstrated efficacy comparable to moxifloxacin, with a safety profile similar to the most widely-used macrolide antibiotics. This shows the potential to restore the use of macrolide monotherapy for CABP.”
Solithromycin is a highly potent next-generation macrolide, the first fluoroketolide, which has activity against the common CABP pathogens and macrolide-resistant bacterial strains. In the intent-to-treat population of this study (ITT, all randomized patients), solithromycin met the primary objective of statistical non-inferiority to oral moxifloxacin for the treatment of CABP with a treatment success rate at the early clinical response (ECR, 72 hours after the first dose of study drug) 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.
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. In addition, there were two cases of Clostridium difficile infection, both of which occurred in the moxifloxacin group.
“SOLITAIRE-ORAL is a landmark study and a significant achievement, as solithromycin is the first new oral CABP drug studied in a global, pivotal Phase 3 study in more than a decade,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “We are extremely pleased that The Lancet Infectious Diseases has chosen to publish these data in their journal.”
In October, Cempra announced successful results of the second Phase 3 pivotal trial of solithromycin that used an intravenous formulation (Solitaire-IV), and has begun and is planning to complete a rolling New Drug Application (NDA) submission to the FDA for the oral and intravenous formulations for the treatment of CABP during the first half of 2016. The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP. The Agency has also designated solithromycin IV and capsules for the treatment of CABP as a Qualified Infectious Disease Product (QIDP).
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 bacterial 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 influenzae, 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 or two 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) has successfully completed two Phase 3 clinical trials 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 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. Taksta™ is Cempra's second product candidate, which is being developed for acute bacterial skin and skin structure infections (ABSSSI) and is also expected to be tested 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: the costs, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; our and our strategic commercial partners’ ability to obtain FDA and foreign regulatory approval of our product candidates; our anticipated capital expenditures and our estimates regarding our capital requirements; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; 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; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; 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.
i Bordon J, Aliberti S, Duvvuri P, et al. Early administration of the first antimicrobials should be considered a marker of optimal care of patients with community-acquired pneumonia rather than a predictor of outcomes. Int J Infect Dis. 2013;17(5):e293-e298.
ii Jones RN, Sader HS, Mendes RE, et al. Update on antimicrobial susceptibility trends among Streptococcus pneumoniae in the United States: a report of ceftaroline activity from the SENTRY Antimicrobial Surveillance Program (1998-2011). Diagn Microbiol Infect Dis. 2013:75:107-109.