Cerexa Reports Positive Top-Line Results for Phase 2 Clinical Trial of Ceftaroline
Broad-Spectrum Anti-Infective Achieves Excellent Clinical, Microbiological Cure Rates for cSSSI Compared to Standard Therapy
ALAMEDA, Calif., Aug. 2, 2006 — Cerexa Inc. today announced positive top-line results for the Phase 2 clinical trial of Ceftaroline for the treatment of complicated skin and skin structure infections (cSSSI).
This observer-blinded trial evaluated Ceftaroline versus standard therapy in 100 patients at 24 study sites worldwide. The clinical cure rate was 96.8% for subjects treated with Ceftaroline and 88.9% for those treated with standard therapy of vancomycin, with or without adjunctive aztreonam, in the clinically evaluable population. The microbiological response rate was 95.2% for the Ceftaroline group and 85.7% for the standard therapy group in the microbiologically evaluable population. Ceftaroline also demonstrated excellent activity against gram-positive and gram-negative organisms isolated from patients in the study, including 100% of MRSA isolates inhibited at 0.5 mg/L or less.
“We’re very pleased with these results,” said Dennis Podlesak, Chief Executive Officer of Cerexa. “Ceftaroline’s high cure rates and broad spectrum of coverage clearly validate its potential as a potent first-line therapy with the significant added benefit of minimizing the need for combination therapy.”
Ceftaroline is a next-generation, broad-spectrum, injectable cephalosporin that combines the advantages of an enhanced gram-positive spectrum, including bactericidal anti-MRSA activity, with broad gram-negative activity. In March 2006 the U.S. Food and Drug Administration granted Ceftaroline Fast Track designation for the treatment of cSSSI caused by MRSA. In granting this designation, the FDA noted that Ceftaroline has the potential to address an unmet medical need due to its ability to benefit patients who are unresponsive to existing therapies or who are unable to tolerate existing therapies due to serious toxicities that are present in such therapies.
Dr. George H. Talbot, Cerexa’s Chief Medical Officer, commented: “Ceftaroline was both highly efficacious and very well tolerated in these seriously ill patients. Given these results, we believe Ceftaroline will be of significant benefit to clinicians and patients who are in urgent need of new treatment options. We look forward to advancing Ceftaroline into Phase 3 clinical trials for complicated skin and other community and hospital acquired infections.”
In the Phase 2 trial, the most common adverse event observed in the Ceftaroline group was mild headache. No drug-related serious adverse events were observed for Ceftaroline. In both the Phase 2 trial and earlier Phase 1 trials, Ceftaroline displayed a favorable adverse event profile consistent with the established safety profile of the cephalosporin class, with the vast majority of side effects being mild in nature. Adverse events typically associated with vancomycin were observed in the Phase 2 comparator group, including interstitial nephritis-related renal failure and “Red Man” syndrome.
Ceftaroline acetate is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In preclinical studies and clinical trials to date, Ceftaroline demonstrated a favorable safety profile, similar to that of existing cephalosporins. Unlike marketed cephalosporins, Ceftaroline exhibits bactericidal activity against the most resistant strains of gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline has also demonstrated bactericidal activity against penicillin-resistant Streptococcus pneumoniae and common gram-negative bacteria. Cerexa licensed from Takeda Pharmaceutical Company Limited the exclusive right to develop and commercialize Ceftaroline in all countries worldwide except Japan.
Cerexa Inc. is an innovation-driven biopharmaceutical company based in Alameda, Calif., that is focused on discovering, developing and commercializing a growing portfolio of novel anti-infective therapies for the treatment of serious, antibiotic-resistant infections. For more information, visit www.cerexa.com.