SAN FRANCISCO, Sept. 29 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. today announced that doripenem, an investigational carbapenem(1) antibiotic in Phase III trials, achieved a high clinical cure rate of 83 percent in patients with intra-abdominal infections. Doripenem also was active against a wide range of Gram-positive(2) and Gram-negative(3) bacteria that cause serious hospital infections -- including Pseudomonas. These data were from two studies presented at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Pseudomonas aeruginosa, a Gram-negative bacterium with increasing multi-drug resistance, is one of the leading causes of nosocomial (hospital-acquired) infections for which treatment options are limited. In general, there are few antibiotics available and in development to treat these life-threatening Gram-negative infections.
In one presentation(4), the first clinical data released from the Phase III clinical program, doripenem was active against major bacteria that cause complicated intra-abdominal infections, including E. coli, B. fragilis, Viridans Group streptococci and Pseudomonas aeruginosa. The primary objective of the study was to evaluate doripenem’s safety and efficacy in the treatment of complicated intra-abdominal infections comparing doripenem (500 mg IV q8h) to meropenem (1 g IV q8h).
In another presentation(5), data from a global surveillance study showed doripenem had greater in vitro activity compared to commonly used antimicrobial therapies against Pseudomonas aeruginosa, Pseudomonas spp., and other Gram-negative organisms. The primary objective of the study was to test the in vitro activity of doripenem and selected comparator compounds against a collection of P. aeruginosa, other non-fermentative(6) Gram-negative bacilli, and Aeromonas spp., a group of opportunistic bacteria with recognized resistance profiles to commonly used antimicrobial agents.
“In an era of increasing multi-drug resistance, the high clinical cure rates seen in this trial suggest that doripenem is effective in treating patients with intra-abdominal infections, including those caused by Pseudomonas,” said principal investigator Osvaldo Malafaia, M.D., Hospital Universitario Evangelico de Curitiba, Brazil.
Study Results
The first presentation described a large, multi-center, randomized, double-blind trial involving 486 patients. In the microbiologically evaluable population (N=315), favorable clinical cure rates were achieved with 83.3% for doripenem and 83.0% for meropenem.
Doripenem was generally well tolerated. The most-frequently reported treatment-related adverse events were nausea, which occurred in 9.5% of the doripenem-treated subjects and in 9.4% of the meropenem-treated subjects; diarrhea was reported in 7.4% of the doripenem-treated subjects and in 7.7% of the meropenem-treated subjects; anemia was reported in 7.0% of the doripenem patients and in 3.9% of the meropenem patients; and vomiting, which was reported in 6.6% of the doripenem-treated subjects and in 6.9% of the meropenem-treated subjects. No seizures were observed in either treatment arm.
In the second presentation from a global surveillance study, doripenem inhibited 85.0% of all tested isolates at a minimum inhibitory concentration (MIC) of less than or equal to 4 ug/ml compared with 80.0% for meropenem and 78.6% for imipenem. Of the 3,875 Pseudomonas isolates tested, doripenem inhibited 87.0% compared with 81.1% for meropenem and 77.8% for imipenem.
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is part of Johnson & Johnson, the world’s most broad-based producer of healthcare products. J&JPRD is headquartered in Raritan, New Jersey (USA), and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
Footnotes: (1) Carbapenems are a class of antibacterial agents useful in treating life-threatening infections caused by Gram-positive and resistant Gram-negative bacteria. (2) Gram-positive indicates a group of bacteria that become violet-colored when the bacterial cells are treated with the Gram stain. This response is based on the chemical composition of their cell walls and is used to identify the type of bacteria. Some Gram-positive bacteria may cause serious infections. (3) Gram-negative indicates a group of bacteria that become red when the bacterial cells are treated using the Gram stain method. This response is based on the chemical composition of their cell walls and is used to identify the type of bacteria. Some Gram-negative bacteria may cause serious infections. (4) “Doripenem Versus Meropenem for the Treatment of Complicated Intra- Abdominal Infections” (Poster L-1564b) (5) “Antimicrobial Activities of Doripenem and other Carbapenems Tested Against Pseudomonas aeruginosa, Other Non-Fermentative Bacilli and Aeromonas spp.” (Poster E-0222) (6) Non-fermentative indicates a group of bacteria whose metabolism does not allow them to ferment glucose. This characteristic is used to identify the type of bacterium. This group includes drug-resistant bacteria that are capable of causing severe disease in humans.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
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