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Cempra Pharmaceuticals Will Present New Data on Solithromycin (CEM-101) and TAKSTA(TM) (CEM-102) at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)

September 9, 2010

CHAPEL HILL, N.C., Sept. 9 /PRNewswire/ — Cempra Pharmaceuticals today announced its schedule of 16 poster presentations at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, Mass., on September 12-15, 2010.

Cempra’s posters will present data on its oral anti-MRSA antibiotic, TAKSTA (sodium fusidate, or CEM-102), and on its novel fluoroketolide antibiotic, solithromycin (CEM-101). The posters on TAKSTA will present data that include Phase 2 study results in patients with acute skin and skin structure infections. Presentations on solithromycin will include Phase 1 results on the safety and pharmacokinetics of oral administration in healthy volunteers.


    Cempra Pharmaceuticals 50th ICAAC Schedule At-A-Glance

    Sunday, September 12, 2010

    Solithromycin

    -- Poster Presentation: "Pharmacokinetics-Pharmacodynamics (PK-
     PD) of CEM-102 (Sodium Fusidate) against Streptococcus pyogenes
     Using In Vitro Pharmacodynamic Models (IVPM)"
    Time: 11:30 a.m. -1:30 p.m. EDT, Presentation # A1-021, Poster Board
     # 18
    Location: Exhibit Hall B1
    B. T. Tsuji(1), A. Forrest(1), (2), P. A. Kelchlin(1), T. Brown(1),
     P. N. Holden(1), O. O. Okusanya(2), S. M. Bhavnani(1), (2), P.
     Fernandes(3), P. G. Ambrose (1),(2) ((1)Univ. of Buffalo, Buffalo,
     NY, (2)ICPD/Ordway Res Inst, Latham, NY, (3)Cempra Pharmaceuticals,
     Chapel Hill, NC)

    Monday, September 13, 2010

    Solithromycin

    -- Poster Presentation: "CEM-101, a Novel Fluoroketolide with
     Exceptional Cellular Accumulation, Localizes in Lysosomes and
     Induces Phospholipidosis but no Apoptosis and Does not Interference
     with the Production of Reactive Oxygen Species (ROS) in Cultured:
     Comparison with Azithromycin (AZM) and Gentamicin (GEN)"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-686, Poster Board
     # 35
    Location: Exhibit Hall B1
    D. Das, F. Van Bambeke, P. M. Tulkens (Universite Catholique de
     Louvain, Bruxelles, Belgium)

    -- Poster Presentation: "Comparison of CEM-101 Metabolism in Mice,
     Rats, Monkeys and Human"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-687, Poster Board
     # 36
    Location: Exhibit Hall B1
    D. E. Pereira, T. Degenhardt, P. Fernandes (Cempra Pharmaceuticals,
     Chapel Hill, NC)

    -- Poster Presentation: "Pharmacokinetic-Pharmacodynamic (PK-PD)
     Analysis of CEM-101 against Streptococcus pneumoniae Using Data
     from a Murine-Lung Infection Model"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-688, Poster Board
     # 37
    Location: Exhibit Hall B1
    D. R. Andes(1), O. O. Okusanya(2), A. Forrest(2), S. M. Bhavnani(2),
     P. Fernandes(3), P. G. Ambrose(2) ((1)Univ Wisc., Madison, WI,
     (2)ICPD/Ordway Res Inst, Latham, NY, (3)Cempra Pharmaceuticals,
     Chapel Hill, NC)

    -- Poster Presentation: "Phase 1 Pharmacokinetic and Safety of
     Multiple Doses and Effects of Food on the Bioavailability of Oral
     CEM-101 in Healthy Adult Subjects"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-689, Poster Board
     # 38
    Location: Exhibit Hall B1
    J. Schranz, K. Clark(1), T. Degenhardt(1), D. Scott1, P.
     Fernandes(1), J. G. Still(2), J. Kissling(3), S. Sharples(3)
     ((1)Cempra Pharmaceuticals, Chapel Hill, NC, (2)Fulcrum Pharma,
     Morrisville, NC, (3)MDS Pharma, Tempe, AZ)

    -- Poster Presentation: "Intrapulmonary Penetration of CEM-101 in
     Healthy Adult Subjects"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-690, Poster Board
     # 39
    Location: Exhibit Hall B1
    K. A. Rodvold(1), M. H. Gotfried (2),(3), O. O. Okusanya (4), A.
     Forrest (4), S. M. Bhavnani (4), J. G. Still (5), K. Clark (5), P.
     Fernandes (5), P. G. Ambrose (4) ((1)Univ. of Illinois at Chicago,
     Chicago, IL, (2)Univ of IL, Chicago, IL, (3)Pulmonary Associates,
     Phoenix, AZ, (4)ICPD/Ordway Res Inst, Latham, NY, (5)Cempra
     Pharmaceuticals, Chapel Hill, NC)

    -- Poster Presentation: "Population Pharmacokinetics (PPK) of CEM-
     101 Using Data from the Plasma and Epithelial Lining Fluid (ELF) of
     Healthy Subjects"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-691, Poster Board
     # 40
    Location: Exhibit Hall B1
    O. O. Okusanya(1), A. Forrest(1), S. M. Bhavnani(1), K. A.
     Rodvold(2), M. H. Gotfried(2), (3), P. Fernandes(4), K. Clark(4), J.
     G. Still(4), P. G. Ambrose(1) ((1)ICPD/Ordway Res Inst, Latham, NY,
     (2)Univ IL, Chicago, IL, (3)Pulmonary Associates, Phoenix, AZ,
     (4)Cempra Pharmaceuticals, Chapel Hill, NC)

    -- Poster Presentation: "Pharmacokinetic-Pharmacodynamic (PK-PD)
     Target Attainment (TA) Analysis Supporting CEM-101 Phase 2 Dose
     Selection"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # A1-692, Poster Board
     # 41
    Location: Exhibit Hall B1
    O. O. Okusanya(1), S. M. Bhavnani(1), A. Forrest(1), P. Fernadnes(2),
     P. G. Ambrose(1) ((1)ICPD/Ordway Res Inst, Latham, NY, (2)Cempra
     Pharmaceuticals, Chapel Hill, NC)

    Tuesday, September 14, 2010

    TAKSTA

    -- Poster Presentation: "Ability of CEM-102 (Fusidic Acid),
     Linezolid, Daptomycin to Select Resistant S.aureus Mutants at
     Steady-State Serum Levels"
    Time: 11:15 a.m. - 1:15 p.m. EDT, Presentation # E-1557, Poster
     Board # 220
    Location: Exhibit Hall B1
    K. Kosowska-Shick, P. McGhee, L. Beachel, P. C. Appelbaum (Hershey
     Med. Ctr., Hershey, PA)

    -- Poster Presentation: "Activity of CEM-102 (Fusidic Acid)
     against 40 MRSA from Cystic Fibrosis (CF) Patients"
    Time: 11:15 a.m. - 1:15 p.m. EDT, Presentation # E-1558, Poster
     Board # 221
    Location: Exhibit Hall B1
    C. Todd, K. Credito, P. McGhee, P. C. Appelbaum (Hershey Med. Ctr.,
     Hershey, PA)

    -- Poster Presentation: "CEM-102 (Fusidic Acid) Maintains Potency
     against Resistant MRSA and Prevalent Hospital Acquired, Community
     Acquired, and Epidemic MRSA Clones:
    Time: 11:15 a.m. - 1:15 p.m. EDT, Presentation # E-1559, Poster
     Board # 222
    Location: Exhibit Hall B1
    C. M. Pillar(1), M. Torres(1), D. F. Sahm(1), P. Fernandes(2)
     ((1)Eurofins Medinet, Chantilly, VA, (2)Cempra Pharmaceuticals,
     Chapel Hill, NC)

    -- Poster Presentation: "In Vitro Activity of Fusicic Acid (CEM-
     102) against Resistant Strains of Staphylococcus aureus"
    Time: 11:15 a.m. - 1:15 p.m. EDT, Presentation # E-1561, Poster
     Board # 224
    Location: Exhibit Hall B1
    J. Dubois(1), P. Fernandes(2) ((1)M360, Sherbrooke, Canada, (2)Cempra
     Pharmaceutical Inc., Chapel Hill, NC)

    -- Poster Presentation: "Efficacy and Safety of CEM-102 in a Phase
     2, Randomized, Double-Blind Study in Patients with Acute Bacterial
     Skin and Skin Structure Infections (ABSSSI)"
    Time: 11:15 a.m. -1:15 p.m. EDT, Presentation # L1-1762, Poster
     Board # 1762
    Location: Exhibit Hall B1
    S. R. Moriarty(1), K. Clark(1), D. Scott(1), T. P. Degenhardt(1), P.
     Fernandes(1), J. C. Craft(1), G. R. Corey(2), J. G. Still(3), A. F.
     Das(4) ((1)Cempra Pharmaceuticals, Chapel Hill, NC, (2)Duke Univ.
     Med. Ctr., Durham, NC, (3)Fulcrum Pharma, Morrisville, NC,
     (4)AxiStat, San Francisco, CA)

    Wednesday, September 15, 2010

    Solithromycin

    -- Poster Presentation: "In Vitro and In Vivo Activity of CEM-101,
     a New Fluoroketolide, Against Mycobacterium avium Complex"
    Time: 9:00 to 11:00 a.m. EDT, Presentation # E-2057, Poster Board #
     72
    Location: Exhibit Hall B1
    C. M. Shoen(1), M. S. DeStefano(1), M. R. Sklaney(1), M. Ackerman(1),
     M.H . Cynamon ((1)Central New York Res. Corp., Syracuse, NY, (2)VA
     Med. Ctr., Syracuse, NY)

    -- Poster Presentation: "Development of an Intravenous Formulation
     of CEM-101, a Novel, Potent Fluoroketolide"
    Time: 9:00 to 11:00 a.m. EDT, Presentation # F1-2151, Poster Board #
     170
    Location: Exhibit Hall B1
    P. B. Fernandes, T. Degenhardt, D. Pereira (Cempra Pharmaceuticals,
     Chapel Hill, NC)

    -- Poster Presentation: "Evaluation of CEM-101, a Novel
     Fluroketolide, in Murine Infection Models"
    Time: 9:00 to 11:00 a.m. EDT, Presentation # F1-2152, Poster Board #
     171
    Location: Exhibit Hall B1
    T. M. Murphy(1), S. Little(1), A. M. Slee(1), P. Fernandes(2)
     ((1)ViviSource Lab., Inc, Waltham, MA, (2) Cempra Pharmaceuticals,
     Inc., Chapel Hill, NC)

About solithromycin (formerly CEM-101)

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

  • 8 to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin
  • Potent in vitro activity against all important respiratory pathogens, including pneumococci, Beta-hemolytic streptococci, staphylococci, Hemophilus, 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 trials of the oral formulation
  • Low resistance frequency in vitro
  • Unlike telithromycin, solithromycin does not inhibit the alpha-7 acetylcholine nicotinic receptor; such inhibition 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
  • Potential for indications beyond CABP, including urethritis and other urogenital infections, bioterrorism targets, malaria, M. avium infections and tuberculosis.

The annual incidence for CABP in the United States is over five million of which over 1 million are 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 growing need for new drugs to address the issues of drug resistance, tolerability, and IV administration associated with currently available treatments. 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.

About TAKSTA(TM)

TAKSTA, (sodium fusidate) is a novel class of antibiotic with an established history of safety and efficacy outside the United States. TAKSTA is being developed as an NCE in the U.S. for aBSSI. Clinical trials with TAKSTA employ a proprietary front-loading oral regimen designed to increase potency, increase coverage and minimize resistance development. Cempra believes that TAKSTA will be an important addition to anti-MRSA therapies based on the following:

  • Sodium fusidate is orally active against gram-positive bacteria, including all S. aureus strains such as HA-MRSA and CA-MRSA
  • TAKSTA employs a novel and proprietary PK-PD-based dosing regimen of sodium fusidate that optimizes efficacy and minimizes the risk of resistance development
  • Sodium fusidate is the only compound within the fusidane class and therefore is unlikely to select for cross-resistance to other classes of antibiotics
  • Sodium fusidate’s safety has been well documented even when used for long periods of time (over one year) to treat osteomyelitis and other serious infections
  • Sodium fusidate has been used safely in children including neonates in countries where it is marketed

About 60 to 80 percent of the 13 million acute skin structure infections that occur in the U.S. each year are infected with MRSA. There is a growing need for an oral anti-MRSA drug that is safe, effective and is safe for long-term administration.

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. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially and medically differentiated and novel products that reduce development risk and provide a high financial return. 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.


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

    Tony Russo, Ph.D.
    Russo Partners, LLC
    (212) 845-4251
    Tony.russo@russopartnersllc.com

SOURCE Cempra Pharmaceuticals


Source: newswire



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