Sepsis drug put back at least two years
pharmafile | November 9, 2006 | News story | Research and Development |Â Â Â
AstraZeneca is being forced to conduct a second phase II trial on its sepsis drug, CytoFab.
This follows discussions with US, EU and Japanese regulators, who ruled that the company should expand its development plan for CytoFab.
The drug is an experimental polyclonal antibody, which has shown strong potential to improve on current treatments. More than 300,000 patients suffer from sepsis in the US alone. The initial phase II CytoFab trial showed a significant drop in deaths and reduced the time patients spent in intensive care.
AstraZeneca has developed the drug in collaboration with biotech company Protherics, based in Brentwood, Essex, and the situation is another blow for AZ following the recent late-stage failure of a number of key products, including the lung cancer drug Iressa and the axing of its medicine for stroke in October.
Consultations with international health regulators have confirmed that a single phase III study could be sufficient to approve the drug; however, AstraZeneca is now required to implement an intermediate phase II programme to support the single global phase III study.
The new phase II trial will begin in the second half of 2007 and is expected to last up to 21 months. It will be used to more accurately estimate the number of patients required and will confirm the appropriate dosage of CytoFab for the phase III study, as well as providing further supporting efficacy and safety data. It will be followed immediately by the start of the phase III trial in the US, EU and Japan.
CytoFab has been out-licensed to AstraZeneca, which is responsible for its global development and sales in an agreement with Protherics, worth up to £195 million in upfront and milestone payments.
Analysts have predicted that, if successful, CytoFab could generate sales of more than £524 million a year.
John Rex, AstraZeneca's vice president and medical director for infection, said: "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."
New regulations were enforced last spring following the clinical trial for an experimental monoclonal antibody at Northwick Park Hospital, London, which left six healthy volunteers seriously ill.
Mr Rex added: "We hope this will help to reduce the size of and the time needed to complete the phase III study."
Protherics' chief executive, Andrew Heath, commented:"CytoFab represents a major market opportunity and AstraZeneca's proposed development programme provides the treatment with the best route to registration. We now have a clear view of the steps needed to make this important new treatment available to sepsis patients worldwide."
At present, there is only one sepsis treatment available, Eli Lilly's Xigris. Recently, GlaxoSmithKline axed its early stage sepsis drug – which used a mechanism different from that of AstraZeneca's product – following disappointing trial results.
