Navigation Links
Cempra Announces Comparable Efficacy of Oral Solithromycin (CEM-101) Compared with Levofloxacin in Phase II Clinical Trial in Patients with Community-Acquired Bacterial Pneumonia (CABP)
Date:9/15/2011

CHAPEL HILL, N.C., Sept. 15, 2011 /PRNewswire/ -- Cempra Pharmaceuticals today announced results from its Phase II clinical trial investigating the efficacy, safety and tolerability of oral administration of our fourth generation macrolide, solithromycin (CEM-101), a fluoroketolide antibiotic, in comparison with oral levofloxacin for the treatment of community-acquired bacterial pneumonia (CABP).  In the Phase II trial, CEM-101 demonstrated efficacy comparable to levofloxacin and a favorable safety and tolerability profile, with a lower incidence of treatment emergent adverse events than levofloxacin.  

"Macrolides have been an important therapeutic option for physicians to use for the treatment of bacterial pneumonia and other infections, but antimicrobial resistance has been increasing among the major pathogens which cause these infections," said Professor Robert Moellering, M.D., Shields Warren-Mallinckrodt Professor of Medical Research at Harvard Medical School.  "A safe macrolide as potent as CEM-101 has the potential of being a very useful agent."

David Oldach, M.D., senior vice president of clinical research of Cempra added, "Results from this trial indicate that CEM-101 is a product candidate with efficacy comparable to levofloxacin, the current standard of care for the treatment of CABP and with a favorable safety profile.  We believe these data validate the dosing strategy of CEM-101 employed in this trial and strongly support progression into Phase III trials. We look forward to presenting the full data set at an upcoming scientific conference."

Study Design

The trial was a randomized double-blind, multi-center study to evaluate the efficacy and safety of oral CEM-101 compared to oral levofloxacin in the treatment of patients with CABP.  One hundred thirty two patients were randomized to receive either CEM-101 (800 mg on Day 1 followed by 400 mg on Days 2 to 5) or levofloxacin (750 mg on Days 1 to 5).  Patients were enrolled if diagnosed with PORT II-to-IV pneumonia.  The primary outcome measure was continued improvement or complete resolution of baseline signs and symptoms in the intent to treat (ITT) and the clinically evaluable (CE) populations at the Test of Cure (TOC) visit, which was completed five to 10 days after the last dose of the drug.

"Cempra's mission is to develop differentiated antibiotics that confront today's challenges of bacterial resistance to existing antibiotics," said Prabhavathi Fernandes, president and chief executive officer of Cempra.  "Completing this Phase II trial is an important milestone for the company. I congratulate our staff for their good work.  The data from this study strongly support further evaluation of orally-administered CEM-101 in the treatment of CABP in an 'all-oral therapy' Phase III trial, and as a component of IV-to-oral Phase III trials."

About CEM-101

CEM-101 is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products.  Our clinical trials and pre-clinical studies have shown that CEM-101, with its unique chemical structure, has:

  • a favorable safety and tolerability profile;
  • comparable efficacy to the current standard of care;
  • potent activity against a broad range of bacteria with excellent tissue distribution and intracellular activity;
  • a lower incidence of resistance development;
  • IV, oral and suspension formulations that allow it to be used in all patient populations and settings; and
  • anti-inflammatory qualities to help patients feel better sooner during treatment.

The annual incidence for CABP in the United States is over five million with over one million hospitalized (File, T.M., Lancet, 2003; File, T.M. and Tan, J.S. JAMA, 2005; CDC, National Hospital Discharge Survey, 2006; File, T.M. and Marrie, T., Postgrad. Med., 2010).  There is a great need for new drugs that are well tolerated and that may be administered both orally and intravenously, to address the crisis of emergent drug resistance. Cempra has licensed exclusive worldwide rights from Optimer Pharmaceuticals, Inc., except in the Association of Southeast Asian Nations (ASEAN) countries, to discover, develop and commercialize macrolides from a library of more than 500 compounds from Optimer's OPopS drug discovery platform, including CEM-101.

About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs in the treatment of infectious diseases caused by bacteria. Our two lead product candidates have both completed oral Phase II clinical trials and seek to address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.

Company Contact:
Prabha Fernandes, Ph.D.
President and Chief Executive Officer
pfernandes@cempra.com
(919) 467-1716


'/>"/>
SOURCE Cempra Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cempra Pharmaceuticals to Present at the 2011 Wells Fargo Healthcare Conference
2. Cempra Pharmaceuticals to Present at the Jefferies 2011 Global Healthcare Conference
3. Cempra Pharmaceuticals to Present at Two Investor Conferences in Paris
4. Intravenous (IV) Administration of Cempra Pharmaceuticals Solithromycin (CEM-101) Demonstrates Excellent Systemic Tolerability in a Phase 1 Clinical Trial
5. Cempra Pharmaceuticals to Present at Two Upcoming Cambridge Healthtech Institute (CHI) Conferences
6. Cempra Pharmaceuticals to Present at Two Upcoming Investor Conferences
7. Cempra Expands Clinical Management Team to Advance Leading Antibacterial Clinical Programs Solithromycin and TAKSTA™
8. Cempra Pharmaceuticals Names Carl Foster Executive Vice President of Business Development
9. Cempra Pharmaceuticals Names Richard Kent, M.D., to Its Board of Directors
10. Cempra Pharmaceuticals to Present at the UBS Global Life Sciences Conference
11. Cempra Pharmaceuticals to Present at the Piper Jaffray 21st Annual Health Care Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... , March 27, 2017  Cryoport, Inc. (NASDAQ: ... it intends to offer shares of common stock in ... statement on file with the Securities and Exchange Commission ... other conditions, and there can be no assurance as ... or as to the actual size or terms of ...
(Date:3/27/2017)... -- To mark the end of Save Your Vision Month, ... digital imaging solutions, will showcase Canon eye care devices during ... New York,s Jacob Javits Center from March 30 ... the American Optometric Association, is observed annually in March to ... exams. In recognition of this observance, Canon U.S.A. ...
(Date:3/27/2017)... March 27, 2017  Sophiris Bio Inc. (NASDAQ: ... a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) ... today reported fourth quarter and full year 2016 ... Key Corporate Highlights: Advanced ... Cancer. During 2016, the Company reported successful results ...
Breaking Medicine Technology:
(Date:3/28/2017)... (PRWEB) , ... March 28, 2017 , ... ... direct measurement of corrosive ions found in power plant water and steam. , ... such as turbines and boilers, leading to extensive maintenance and unplanned shutdowns. Monitoring ...
(Date:3/28/2017)... ... ... A minimally invasive porcelain veneer is increasing in popularity ... Dental Laboratories (NADL) is informing dentists about the benefits of minimally invasive dentistry, ... and technicians that create these veneers. , According to National Board for ...
(Date:3/28/2017)... Atlantic City, NJ (PRWEB) , ... March 28, ... ... annual American Camp Association’s Tri-State Camp Conference in Atlantic City March 13-16, was ... partners, and their team of professional staff discussed strategies for preventing outbreaks among ...
(Date:3/28/2017)... ... 2017 , ... Thank you to all who attended Capio Partners Winter 2017 ... was exclusive to providers and offered an opportunity to collaborate and network with healthcare ... Grand Hyatt where attendees gathered for a lively discussion on trends and issues that ...
(Date:3/27/2017)... ... March 27, 2017 , ... New patients who have sleep apnea ... with or without a referral. Sleep apnea is often left untreated because patients are ... headaches and chronic snoring. , Dr. Braasch seeks to raise awareness of sleep ...
Breaking Medicine News(10 mins):