CHAPEL HILL, N.C., March 31, 2012 /PRNewswire/ -- 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 data will be presented at the [ European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) ], in London, March 31 to April 3,demonstrating CEM-101's (solithromycin's) efficacy to be comparable to levofloxacin in a Phase 2 trial of patients with community-acquired bacterial infections (CABP). The study also demonstrates solithromycin's favorable safety and tolerability profile compared to levofloxacin.

"This is the first time that the full data set of this Phase 2 trial has been available for review by the infectious disease community," said Prabhavathi Fernandes, chief executive officer of Cempra. "The promising results of this clinical trial will now be the basis for the initiation of our Phase 3 program in CABP. We expect to begin the first Phase 3 trial evaluating oral solithromycin in moderate-to-moderately severe CABP patients in the second half of 2012. Additionally, we are planning Phase 3 trials for 2013 testing the efficacy of intravenous-to-oral step down administration of solithromycin in moderate-to-severe CABP."

CABP is the number one cause of death due to bacterial infection in the U.S. There are over five million cases per year resulting in about one million hospitalizations per year. Macrolide antibiotics, such as azithromycin (52 million prescriptions in 2010), have been the mainstay of respiratory tract infection treatment but bacterial resistance has been increasing to as high as 30 percent of pneumococcal isolates in the United States. New antibiotics are needed to confront this rising public health issue.

Oldach et al., ([ Abst. # P719 ]; 3:30 to 4:30 p.m. BST, Saturday, March 31) conducted a multi-center, double-blind, randomized Phase 2 clinical trial to evaluate oral solithromycin versus oral levofloxacin in the treatment of adults with moderate to moderately-severe CABP. One-hundred-thirty-two patients were randomized to receive either solithromycin (800 mg on day one followed by 400 mg on days two to five) or levofloxacin (750 mg on days one through five). The primary outcome measure was investigator's assessment of clinical success at test-of-cure (TOC; four to 11 days after the last dose of study drug) in the intent-to-treat (ITT) and clinically-evaluable (CE) populations. Early response to treatment (at day three) was defined as improvement in at least two symptoms (cough, sputum production, chest pain, dyspnea) without worsening in any.

Clinical success rates for solithromycin, compared to levofloxacin, were comparable across endpoints (TOC both ITT and CE, day three ITT and microbiological ITT). Solithromycin-treated patients experienced fewer treatment-emergent adverse events (29.7%) than levofloxacin-treated patients (45.6%). No patients on solithromycin discontinued treatment due to an adverse event whereas six patients on levofloxacin discontinued treatment due to an adverse event. Solithromycin demonstrated efficacy comparable to levofloxacin with a favorable safety and tolerability profile that showed fewer treatment-emergent adverse events than levofloxacin.

About CEM-101 (solithromycin)

Solithromycin is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products:

Eight to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin
Potent in vitro activity against a broad range of respiratory pathogens, including pneumococci, beta-hemolytic streptococci, staphylococci, Haemophilus, Legionella, Mycoplasma, Moraxella and Chlamydophila
Potent in vitro activity against other medically significant pathogens, including CA-MRSA, M. avium, malaria, enterococci and gonococci
Good tolerability to date as demonstrated in Phase 1 and 2 trials of the oral formulation
Low resistance frequency in vitro
No pyridine sidechain, unlike telithromycin; the pyridine moiety is believed responsible for certain adverse effects observed with telithromycin (Ketek®).
Excellent tissue distribution and intracellular tissue concentrations, including lung epithelial lining fluid and alveolar macrophages
Oral and IV formulations concurrently in development
Once-daily dosing

About Cempra Inc.
Founded in 2006, 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 have both completed oral Phase 2 clinical trials and seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company also intends to utilize its series of proprietary lead compounds from its novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Additional information about Cempra can be found at [ 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, timing, regulatory review and results of our studies and clinical trials; 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 obtain FDA approval of our product candidates; our dependence on the success of CEM-101 and Taksta; 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 CEM-101 and Taksta;our ability to produce and sell any approved products and the price we are able 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; 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.

Investor Contacts:
Robert E. Flamm, Ph.D.
Russo Partners LLC
(212) 845-4226
[ Robert.flamm@russopartnersllc.com ]

Andreas Marathovouniotis
Russo Partners LLC
(212) 845-4235
[ Andreas.marathis@russopartnersllc.com ]

Media Contact:
Elliot Fox
Russo Partners LLC
(212) 845-4253
[ elliot.fox@russopartnersllc.com ]

SOURCE Cempra Inc.

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Cempra Inc. Presents Full Data Set of Phase 2 Clinical Trial of CEM-101 (Solithromycin) in Community-Acquired Bacterial Pneumon

Cempra Inc. Presents Full Data Set of Phase 2 Clinical Trial of CEM-101 (Solithromycin) in Community-Acquired Bacterial Pneumonia Patients at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

-Solithromycin demonstrated efficacy comparable to levofloxacin and favorable safety and tolerability