Janssen culls BARDA-funded flu phase 3 antiviral pimodivir after failing to help hospitalized patients

In a reminder to the world of how hard it is to kill viruses and help those infected, Janssen has been forced to terminate its influenza A antiviral hopeful.

Interim data out of the late-stage trial of pimodivir, originally licensed from Vertex, show that, when put together with the current standard of care, it “was very unlikely to demonstrate added benefit in hospitalized patients with influenza A compared to SOC treatment alone.”

The test will now be axed, as will a parallel phase 3 in outpatients with influenza A. Janssen said it had looked at the data at its preplanned interim point.

It has not disclosed full details of the results, but said it spoke with the Biomedical Advanced Research and Development Authority, which had been helping fund the drug, before its cull.

There are four types of influenza viruses: A, B, C and D. Human influenza A and B viruses cause seasonal epidemics of disease almost every winter in the U.S., with the A strain the only influenza virus known to cause flu pandemics.

There are vaccines for these flu types, but they can have limited efficacy. The Centers for Disease Control and Prevention estimates that influenza has resulted in between 9 million to 45 million illnesses, between 140,000 and 810,000 hospitalizations and between 12,000 to 61,000 deaths annually over the last decade.

There are few antivirals for influenza, with Roche’s Tamiflu one of the core recent approvals. J&J will hope to have better luck with its COVID-19 vaccine attempt, which started trials in the summer.

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“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," said James Merson, Ph.D., global therapeutic area head for infectious diseases at Janssen R&D.   

“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 programs that we believe will offer transformational medical innovation to patients.”

In the midst of a pandemic and a host of antivirals in development against SARS-CoV-02, this serves a dark reminder of how tough R&D against infectious disease can be.