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Pimodivir decreases viral load in adults with uncomplicated seasonal influenza A

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Treatments containing pimodivir significantly decreased viral load over 7 days in adult patients with acute, uncomplicated seasonal influenza A, according to a news release announcing results of a phase 2b trial.

According to the release, pimodivir (Janssen) received FDA Fast Track designation in March “due to its potential to address an unmet medical need in those who develop influenza A infection and who are hospitalized or at high risk of related complications.” Janssen expects phase 3 studies to start later this year.

The investigational drug is described in the news release as being a “first-in-class inhibitor of the PB2 subunit of the influenza A polymerase complex.” According to the release, it targets an alternative part of the viral replication process and may be used to treat influenza A virus infections that have developed resistance to existing antivirals with other modes of action.

“Influenza is one of the most serious global public health threats, and important concerns remain about the emergence of antiviral resistance and the lack of approved medications for use in people hospitalized with the virus,” Julian A. Symons, DPhil, vice president, disease area R&D leader, respiratory infections, Janssen, said in the release. “Through the development of pimodivir, Janssen aims to provide a treatment option for people infected with the influenza A virus that will address these gaps.”

Compared with placebo, treatment with pimodivir resulted in a statistically significant decrease in area under the curve (AUC) of viral load measured by qRT-PCR over 7 days from start of dosing at doses of 300 mg (–3.6 AUC; 95% CI, –7.1 to –0.1) and 600 mg (–4.5 AUC; 95% CI, –8.0 to –1.0).

Patients treated with a combination of 600 mg of pimodivir and 75 mg of Tamiflu (oseltamivir, Roche) also demonstrated a significantly lower viral load compared with placebo (–8.6 AUC; 95% CI, –12.0 to –5.1) and 600 mg of pimodivir alone (–4.1 AUC; 95% CI, –7.4 to –0.7).

According to the release, results of the study were presented this week at the 5th International Society for Influenza and Respiratory Disease Antiviral Group Conference in Shanghai. Symons said the results demonstrated that pimodivir, “if successfully developed and approved, could be an important treatment option for influenza A.”

Disclosure: Symons works for Janssen.