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Enrollment opens for European New Drugs 4 Bad Bugs antibiotic program

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The first patient has been enrolled in the New Drugs 4 Bad Bugs program’s COMBACTE-MAGNET project to explore novel antibiotics, according to a drugmaker’s press release.

The New Drugs 4 Bad Bugs (ND4BB) program — funded by the Innovative Medicines Initiative and launched in May 2012 — was developed in response to the growing threat of antibiotic resistance in Europe.

COMBACTE-MAGNET, a project within ND4BB, was formed 2 years ago to investigate the prevention of nosocomial respiratory infections and treatment options for patients with multidrug-resistant gram-negative bacilli.

The project has developed two antibacterial molecule candidates: MEDI3902, a monoclonal antibody designed to prevent nosocomial pneumonia caused by the drug-resistant pathogen Pseudomonas aeruginosa; and AIC499, a beta-lactam antibiotic anticipated to treat MDR gram-negative bacilli.

The SAATELLITE phase 2 clinical trial will study the effectiveness of monoclonal antibody MEDI4893 by assigning it to recruited patients who are intubated and on mechanical ventilation to prevent Staphylococcus aureus. The FDA granted the trial’s sponsor, MedImmune, with fast track designation. The trial expects to enroll 462 patients across 80 European sites, the release said.

“An increase in emergence of antimicrobial resistance and a steady decline in the number of novel antimicrobials being developed across industry have significantly limited treatment options for diseases like nosocomial infections and pneumonia caused by S. aureus,” Hasan Jafri, MD, MedImmune’s senior director of clinical research and development, infectious disease and vaccines, said in the press release. “Novel biologics under investigation such as MEDI4893 may offer a unique opportunity to help prevent these serious infections without inducing antimicrobial resistance.”

Thirty-three academic partners and five pharmaceutical companies are involved in the COMBACTE-MAGNET project, according to a press release from University Medical Center Utrecht in the Netherlands.

COMBACTE has a €167 million ($189 million) budget and a 7-year project time for conducting various trials that aim to reduce antimicrobial resistance. About 25,000 deaths — costing €1.5 billion ($1.7 billion) — occur annually in Europe, with the majority due to gram-negative bacteria, the release said.