Janssen Pharmaceutical has decided to halt the clinical development of an experimental antiviral drug, pimodivir, to treat patients with influenza A infection.
The decision is based on data from pre-planned interim analyses of a Phase III trial of pimodivir in hospitalised influenza A patients.
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Data showed that the drug in combination with the standard of care (SOC) was not likely to demonstrate added benefit when compared to SOC treatment alone.
The Phase III programme of pimodivir was designed to assess the safety and efficacy of the drug in two trials when given in combination with SOC.
One of the two Phase III trials was for hospitalised adolescent, adult and elderly patients with influenza A, while the second trial enrolled non-hospitalised adolescent, adult, and elderly patients at risk of developing complications.
The decision to terminate clinical development comes after consultation with the US Biomedical Advanced Research and Development Authority (BARDA), which provided funding to support pimodivir development programme.
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By GlobalDataJanssen Research & Development Infectious Diseases global therapeutic area head James Merson said: “While our goal was to develop an innovative new treatment option for patients at risk of respiratory infections, unfortunately these data show that pimodivir does not offer a benefit above the existing standard of care.
“At Janssen, we have a deep heritage of caring for those affected by respiratory infectious diseases and will continue to do so, focusing on clinical development programmes that we believe will offer transformational medical innovation to patients.”
The company is currently informing all study investigators and relevant health authorities regarding its decision.
Janssen signed an exclusive licence agreement with Vertex in 2014 for the global development, manufacturing and commercialisation of pimodivir.
In June this year, the company decided to suspend the Phase III LOTUS clinical trial of Stelara (ustekinumab) in systemic lupus erythematosus (SLE) patients over efficacy data.
Results from a pre-planned interim efficacy analysis showed that the drug lacked efficacy in this indication.
