Influenza
Influenza is a severe respiratory illness with outbreaks of disease primarily 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, oseltamivir (Tamiflu®), zanamivir (Relenza™) and Xofluza®, have appeared and in some cases are predominant.
There are three types of influenza viruses: A, B and C. Influenza A and B viruses are significant human respiratory pathogens that cause seasonal flu. Influenza A viruses are historically responsible for multiple major influenza pandemics worldwide. Influenza C tends to cause only mild illness.
To learn more about influenza, please visit the information page at the Centers for Disease Control and Prevention (CDC).
We have developed novel, broad-spectrum antivirals that are specifically designed to be effective against all significant pandemic and seasonal influenza strains, and to have a high barrier to resistance due to the way they target the virus’ replication machinery.
CC-42344 - Influenza A PB2 Inhibitor
CC-42344 is our novel, broad-spectrum, antiviral investigational candidate for the treatment of pandemic and seasonal influenza A. 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.
We are conducting a Phase 2a human challenge study in the United Kingdom to evaluate safety, and viral and clinical measures in healthy volunteers who are challenged with oral influenza A. We advanced into Phase 2a testing following favorable safety and tolerability results reported in our Phase 1 study with CC-42344 conducted in Australia. 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 - Inhaled Influenza A PB2 Inhibitor
Preparations are underway to begin a Phase 1 study in Australia with inhaled CC-42344 as a potential influenza A treatment and prophylaxis for those exposes to the virus. Based on our recent preclinical data, inhaled CC-42344 exhibits highly effective delivery into the lung, superior lung exposure, efficacy in influenza-infected human lung epithelia and a favorable safety profile.
Replication Inhibitor – Influenza A/B
We are in preclinical development with replication inhibitor compounds for influenza types A and B. While it may cause a less severe reaction than the type A virus, influenza type B virus can be extremely harmful.
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
|