A second set of positive phase III data on Cubist Pharmaceuticals’ antibiotic CXA-201 has put the drug on track for regulatory filings in 2014.
The latest data in 993 adults with complicated intra-abdominal infections showed CXA-201 (ceftolozane/tazobactam) in combination with metronidazole was at least as effective as meropenem in achieving a clinical cure rate within 30 days of the start of therapy.
Last month, Cubist reported data from another phase III trial, which showed that CXA-201 met its primary goal of non-inferiority to levofloxacin in the treatment of complicated urinary tract infections. With positive data in hand from two trials the company plans to file for approval in the US in the first half of 2014, with an EU filing following a few months later.
CXA-201 combines a novel cephalosporin (ceftolozane) with a well-established beta-lactamase inhibitor and is designed to tackle Gram-negative bacterial infections. These are particularly tricky to treat as Gram-negative bacteria have a double-layered cell wall, which makes it difficult for drugs to enter and remain in the cell.
Data from the latest study demonstrated that CXA-201 was within 10 per cent of meropenem’s efficacy according to the criteria used by the FDA to demonstrate non-inferiority. Similarly, the antibiotic met the 12.5 per cent non-inferiority margin in criteria used by the EMA.
Cubist’s share price rose around 6 per cent yesterday – having already climbed around 11 per cent last month on the back of the urinary tract infection data – which reflects the importance ascribed to new antibiotics as the current arsenal starts to lose efficacy.
“These data are encouraging as we face alarmingly increasing rates of bacterial resistance,” commented Philip Barie, executive director of the Surgical Infection Society Foundation for Research and Education (SISFRE) in the US.
“There is an urgent need for new antibiotics, especially in the hospital setting, in order to be able to manage effectively those conditions complicated by serious infections,” he added.
The 1980s and 1990s saw dozens of new antibiotics introduced onto the market, but there have just been two launches in the last five years and resistance is on the rise for many serious pathogens. Of late, however, there have been signs that pharma companies are re-capturing their taste for antibiotics research.
For example, AstraZeneca (AZ) signed a deal with Singapore research organisation A*STAR last month to find new antibiotics, and has also formed a research collaboration with Sanofi, GlaxoSmithKline, Janssen and Basilea to tackle resistance. Meanwhile, Roche also made a return to antibiotics research after it acquired an antibiotic from Polyphor.