Influenza

Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in outbreaks of disease mainly during the winter months.

Currently approved antiviral treatments for influenza are partially effective and prone to viral resistance. Strains of flu virus that are resistant to approved treatments, osteltamivir (Tamiflu®), zanamavir (Relenza™) and Xofluza®, have appeared and in some cases are predominant.

To learn more about influenza, please visit the information page at the Centers for Disease Control and Prevention (CDC).

Reference: https://www.cdc.gov/flu/

We are developing novel, broad-spectrum influenza antivirals that are specifically designed to be effective against all significant pandemic and seasonal influenza A strains of the influenza virus and to have a high barrier to resistance due to the way they target the virus’ replication machinery. Our uniquely developed molecules target the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains, including pandemic strains.

Program Discovery Preclinical Phase 1 Phase 2 Phase 3
Influenza A Oral PB2 Inhibitor CC-42344
Discovery Phase complete
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Influenza A Inhaled PB2 Inhibitor CC-42344
Discovery Phase complete
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
Influenza A/B Replication Inhibitors
Discovery Phase complete
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started

CC-42344 - Influenza A PB2 Inhibitor

CC-42344, our novel, broad-spectrum, orally administered antiviral investigational candidate for a potential treatment of pandemic and seasonal influenza A infection. It binds to a highly conserved PB2 site of influenza A polymerase complex and exhibits a novel mechanism of action which inhibits replication. In late 2022 we completed a Phase 1 study with CC-42344 for the treatment of pandemic and seasonal influenza A conducted in Australia and reported favorable safety and tolerability results.

A Phase 2a human challenge study is underway in the UK to evaluate safety, viral and clinical measures in subjects challenged with influenza A. 

In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles. CC-42344 inhibits the first step in influenza A’s viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication. We discovered CC-42344 using our proprietary structure-based drug discovery platform technology.