Cempra to Present Data on Solithromycin at ECCMID Highlighting Potential New Indications, Safety and Activity Spectrum

CHAPEL HILL, N.C., May 9, 2014 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP) today announced that it will present data at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain, that continue to enhance the profile of solithromycin in regards to potential new indications, safety and spectrum of activity particularly against contemporary strains. Presentations will occur on Saturday, May 10 to Tuesday, May 13.

Key points:

  • Solithromycin demonstrates activity in an animal model for otitis media adding another potential use to the growing list of indications for solithromycin
    • Abstract P0097; Poster Session I: Animal models: treatment; 3:30-4:30 p.m. CET, Saturday, May 10; Efficacy of Solithromycin (CEM-101) for Experimental Otitis Media (EOM) due to Nontypable Haemophilus influenza (NTHi) and Streptococcus pneumonia (SP)
      M. Figueira and S.I. Pelton
    • Evaluated pharmacokinetics, middle ear fluid concentrations and microbiologic efficacy of solithromycin in a chinchilla model
    • At a dose that best matched human single dose PK parameters, solithromycin cleared infections caused by H. influenza and S. pneumonia
  • Solithromycin demonstrates safety and tolerability in patients with chronic liver disease
    • Abstract P1686; Poster Session VI: PK/PD of antifungals and miscellaneous antibacterials; 12:30-1:30 p.m. CET, Tuesday, May 13; Safety and Pharmacokinetics in Subjects with Hepatic Impairment
      B. Jamieson, S. Ciric, C. Roskak and P. Fernandes
    • Solithromycin is metabolized in the liver; safety and pharmacokinetics were evaluated in patients with mild to severe hepatic insufficiency
    • Solithromycin was well tolerated in chronic kidney disease patients with no significant differences compared to healthy controls; no dose adjustments were required
  • Fluoroquinolone drug regimens result in higher adverse event rates than macrolide-containing regimens
    • Abstract eP066: Eposter Viewing: Community-acquired pneumonia; Saturday, May 10 to Tuesday, May 13; Antibiotic Treatment Patterns and Outcomes Among Patients Hospitalized in ICU with Community-Acquired Bacterial Pneumonia: A US Cohort Study
    • S. Eapen, E.G. Tuttle, C.J. Llop and M. Barrett
    • Evaluated the rate of rehospitalizations, adverse events and mortality in patients in U.S. intensive care units for CABP by type of antibiotic administered
    • Fluoroquinolone + ceftriaxone regimens showed a 38% increased rate of rehospitalization, an 8% increased risk of adverse events and a 67% increased risk of mortality compared to macrolide + ceftriaxone regimens; this demonstrated the relative safety of macrolide-containing drug regimens for CABP
  • Five abstracts add to data demonstrating solithromycin's activity against contemporary pathogens including resistant strains
    • Abstract P1583: Poster Session VI: Resistance surveillance: Gram positives and others; 12:30-1:30 p.m. CET, Tuesday, May 13; Prevalence of SCCmec Types and Solithromycin Susceptibility of Methicillin-Resistant Staphylococcus aureus (MRSA) from Respiratory Samples Collected in 2012-13
      I. Morrissey, P. Fernandes, C. Tacchini and S.P. Hawser
    • Abstract P1585; Poster Session VI: Resistance surveillance: Gram positives and others; 12:30-1:30 p.m. CET, Tuesday, May 13; Activity of Solithromycin Against Azithromycin-Resistant Streptococcus pneumoniae with Characterised Resistance Mechanisms
      I. Morrissey, P. Fernandes, B. Lemos and S.P. Hawser
    • Abstract eP191; Eposter Viewing: Antibacterial drug activity and interactions in Gram-positive organisms; Saturday, May 10 to Tuesday, May 13; Antimicrobial Activity of Solithromycin Tested Against Serotype Macrolide-Resistant Streptococcus pneumonia Collected from Medical Centers Across the USA (2012)
      D.J. Farrell, R.E. Mendes, R.N. Jones
    • Abstract P1584; Poster Session VI: Resistance surveillance: Gram-positive and others; 12:30-1:30 p.m. CET, Tuesday, May 13; Activity of Solithromycin and Comparators Against Streptococci Isolated from Respiratory Samples Collected in 2012-2013
      I. Morrissey, P. Fernandes, B. Lemos and S.P Hawser
    • Abstract eP190; Eposter Viewing: Antibacterial drug activity and interactions in Gram-positive organisms; Saturday, May 10 to Tuesday, May 13; Comparison of Solithromycin MIC Against Respiratory Streptococci Determined by EUCAST and CLSI Broth Microdilution Methodology
      I. Morrissey, P. Fernandes, B. Lemos and S.P Hawser


Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra said, "We continue to collect exciting data on the emerging profile of solithromycin, our fourth-generation macrolide. The data presented at this year's ECCMID are excellent examples of that trend. Proof of concept in otitis media was presented and this adds to the broadening use potential of solithromycin that includes pediatric use, infections in pregnancy, gonorrhea and non-infectious diseases such as COPD and NASH among others. We also presented the full hepatic insufficiency study that we announced in 3Q13, which demonstrated the benign tolerability profile seen to date. The emerging safety profile is promising based on this study as well as the safety profile seen in our Phase 2 CABP trial and the lack of a QT effect in our Thorough QT study."

About Cempra, Inc.

Founded in 2006, Cempra, Inc. is a late clinical-stage pharmaceutical company focused on developing antibiotics to treat critical bacterial infections in patients in both acute and primary care settings. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin (CEM-101) is in 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. TAKSTA™ (CEM-102) is Cempra's second product candidate currently in a Phase 2 clinical trial for prosthetic joint infections. TAKSTA was recently granted orphan drug designation for this indication. Both product candidates 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 uses such as the treatment of 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 results of studies of our product candidates conducted by others; the results, timing, costs and regulatory review 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 solithromycin and Taksta; and innovation by our competitors. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

CONTACT: Investor and Media 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.comSource:Cempra, Inc.