Ceftobiprole, an antibiotic in development at Swiss drugmaker Basilea, is the first to broad-spectrum cephalosporin to show efficacy in a large clinical trial against methicillin-resistant Staphylococcus aureus (MRSA), a superbug that has emerged as a major problem in hospitals and nursing homes around the world.
The data, reported at the Interciences Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, puts Basilea on track to file for approval of ceftobiprole next year in the USA and Europe.
The results found that the cephalosporin achieved a 93% clinical cure rate in patients with complicated skin and soft tissue infections, comparable to that achieved by vancomycin, a last-line antibiotic used for serious resistant infections. Among MRSA infections the cure rates were 92% and 90%, respectively.
“In contrast to vancomycin, ceftobiprole has in vitro microbiological activity against a broad spectrum of Gram-positive and Gram-negative pathogens,” said Basilea. Analysts have predicted that peak sales of new antibiotics that can add to the armamentarium against MRSA and other problem pathogens lie in the several hundred million dollar to $1 billion range.
Ceftobiprole is one of several new drugs that have been developed to combat emerging resistant infections in recent years, after a prolonged period where research into new antibiotics was on the wane. Others include Pfizer's Zeven (dalbavancin) and Zyvox (linezolid), Cubist Pharmaceuticals' Cubicin (daptomycin), Theravance's televancin and Wyeth's Tygacil (tigecycline).
The antibiotic is partnered with US drugmaker Johnson & Johnson and is also in testing as a treatment for community-acquired pneumonia.
Meanwhile, Basilea also presented Phase II data at ICAAC on its antifungal candidate BAL8557, designed to offer more convenient dosing and fewer drug interactions than current drugs on the market. BAL8557 is scheduled to start Phase III testing in severe invasive candida and aspergillus infections by the end of the year.
Results to date suggest that the antifungal could be suitable for once-daily and perhaps once-weekly administration as an oral dose, as well as being suitable for simple intravenous administration.
There is a pressing need in the marketplace for new treatment options, noted Basilea. Currently available antifungal drugs are reported to fail in more than 50% of patients with acute invasive aspergillosis and in 20-30% of patients with candidemia.