Janssen Discontinues Phase 3 Development of First-in-Class Influenza Drug Pimodivir Due to Lack of Efficacy
Sep 03, 2020 15:16
CST Updated
15:16
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
September 03, 2020 News /BioonBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that it has made a strategic decision to halt the development of pimodivir, an oral antiviral drug for the treatment of influenza A virus infection.
This decision is based on the results of a pre-planned interim analysis of the recent Phase 3 trial of pimodivir in hospitalized patients with influenza A. The analysis found that pimodivir combined with standard of care (SOC) was unlikely to demonstrate additional benefit compared to SOC alone in hospitalized patients with influenza A. Both this study in hospitalized patients and another parallel Phase 3 study in outpatients with influenza A will be terminated.
Dr. James Merson, Global Therapeutic Area Head of Infectious Diseases at Janssen Research & Development, stated, “Although our goal was to develop an innovative new treatment regimen for patients at risk of respiratory infections, unfortunately, these data indicate that pimodivir did not provide benefits beyond the current standard of care. Janssen has a long-standing heritage in the care of respiratory infectious diseases, and we will continue this commitment by focusing on clinical development programs that we believe will deliver transformative medical innovations for patients.”
Chemical Structure of Pimodivir (Image source: medchemexpress.cn)
Pimodivir is a first-in-class antiviral drug that targets the PB2 subunit of the influenza virus polymerase complex.
In 2014, Janssen entered into an exclusive licensing agreement with Vertex to develop, manufacture, and commercialize pimodivir worldwide. The key to treating influenza A lies in overcoming drug resistance, and pimodivir addresses this challenge through a novel mechanism of action by inhibiting the PB2 subunit of the influenza virus polymerase complex. Previously,FDAPimodivir has been granted Fast Track Designation (FTD).
In the Phase IIb clinical trial published in 2017, pimodivir monotherapy significantly reduced viral load in patients for up to 7 days compared with placebo. Furthermore, combination therapy with pimodivir and oseltamivir (OST) reduced viral load to even lower levels.
The Phase 3 studies of pimodivir were designed to evaluate the safety and efficacy of pimodivir in combination with standard of care (SOC) for the treatment of hospitalized adolescents, adults, and elderly patients with influenza A infection (NCT03376321, referred to as Study 3001), and for the treatment of adolescent, adult, and elderly outpatients with influenza A infection who are at risk of developing complications (NCT03381196, referred to as Study 3002). Janssen is currently notifying all investigators and relevant health authorities.
This decision was made in consultation with the U.S. Biomedical Advanced Research and Development Authority (BARDA), which also co-funded the pimodivir project. Under contract HHSO100201500014C, the pimodivir development program received funding support from BARDA.(Bioon.com)
Original Source: Janssen to Discontinue Pimodivir Influenza Development Program