AstraZeneca expands development plan for new sepsis drug

AstraZeneca, the UK’s second-largest pharmaceutical company, has announced new development plans for CytoFab, a new treatment for severe sepsis, which could help to shorten the product’s phase III programme.

The company has revealed it will initiate a new 480-patient phase II study to help support a single phase III study, which it says could be enough to secure the drug’s regulatory approval in the EU and US. The new study will begin in the second half of 2007.

CytoFab is part of a collaboration between AstraZeneca and Protherics, which is responsible for the supply of the drug – a “major market opportunity”, according to its chief executive, Andrew Heath.

John Rex, vice president and medical director for infection at AstraZeneca, commented: “To increase the likelihood of success in this complex disease and reflecting the changing regulatory environment for biologics, we have made the decision to undertake additional clinical work.”

“We believe that this development plan will give us the best chance of successful registration for this exciting treatment,” he added.

AstraZeneca’s product pipeline has suffered a number of setbacks in recent months – last week, new trial results for the investigational drug NXY-059 demonstrated “no efficacy” in treating acute ischaemic stroke, while other therapies like Galida, the diabetes treatment, and Exanta, the anticoagulant, have been discontinued.

However, the company has entered into a number of research and development contracts and recently acquired Cambridge Antibody Technology.