Cubist Pharmaceuticals, Inc., a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections, has announced the presentation of additional clinical data on its investigational antibiotic Cidecin (daptomycin for injection) at the Annual Meeting of the Surgical Infection Society (SIS) in Madrid, Spain. This is the first presentation of Cidecin data at a scientific surgical meeting; surgeons would represent a large target market for Cidecin, should it receive regulatory approval.
During a session entitled "Clinical Therapy: Antibiotics & Nutrition," Jacobus E.J. "Jake" Krige, MD, of the Department of Surgery Observatory at the University of Cape Town Medical School, Cape Town, South Africa, presented new data from two previously completed Phase III clinical trials evaluating the safety and efficacy of Cidecin in the treatment of complicated skin and soft tissue (cSST) infections caused by Gram-positive bacteria.
In both studies, Cidecin achieved the required endpoint of statistical equivalence to the comparator agents. Patients were randomized to Cidecin, 4 mg/kg once daily, or to comparator, where investigators had the choice of vancomycin, given twice daily, or a semi-synthetic penicillin (usually oxacillin) given four times daily. During his presentation, Dr. Krige highlighted three new subset data analyses from the two Cidecin Phase III cSST clinical trials, referred to as Studies 9801 and 9901.
The first analysis detailed data from Study 9801, in which subjects treated with Cidecin showed a trend towards faster mean time to defervescence (the return of elevated body temperature to normal)--one full day less than patients receiving the comparator agents.
In addition, at the point in the study where 50% of patients had defervesced in each group, Cidecin showed a statistically significant faster time to defervescence, 2.00 days versus 3.00 days for comparator (p value: 0.043 by log-rank analysis). Time to defervescence was a prospective secondary endpoint in this clinical trial. These data are consistent with clinical results on time to resolution of signs and symptoms and duration of intravenous therapy from Studies 9801 and 9901 previously presented at scientific meetings.
The second analysis detailed clinical success rates from all patients in Studies 9801 and 9901 with surgical infections including abscesses and wound infections. These data have been analyzed for the surgical community, as they are representative of typical complicated skin and soft tissue infections treated by surgeons.
The third analysis focused on the need for dosage adjustments in subjects in Study 9801 receiving the comparator agent vancomycin. Forty-seven percent of the 153 subjects treated with vancomycin were determined by investigators to require dosage adjustments while on therapy for reasons including decreased renal function and observed blood levels outside the standard vancomycin therapeutic range. No subjects receiving daptomycin needed adjustments to the once-daily dosing regimen while on therapy.
Francis P. Tally, MD, executive vice president, scientific affairs and chief scientific officer of Cubist commented: "In previous studies, Cidecin has demonstrated rapid bactericidal activity in both in vitro and animal models. Although the U.S. Food & Drug Administration and other regulatory bodies will determine whether Cidecin is safe and effective in the treatment of cSST infections, we continue to be encouraged by data from our Cidecin cSST Phase III studies suggesting trends in faster time to defervescence, quicker resolution of signs and symptoms and fewer days of intravenous therapy to achieve clinical success."