Enanta secures FDA fast track designation for EDP-323 to treat RSV
07 Apr 2023
Fast TrackClinical Result
Preview
Source: Pharmaceutical Technology
Electron micrograph depicting the Respiratory Syncytial Virus pathogen.. Credit: CDC/ Dr. Erskine Palmer / commons.wikimedia.org.
Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV).
In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B.
Consistent potency was also observed across a range of RSV clinical isolates in several cell types.
Treatment with EDP-323 for RSV infection in a mouse model demonstrated dose-dependent decrease in viral load in the lung, reduced lung immunopathology as well as decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β.
Furthermore, EDP-323 claims to have a favourable oral bioavailability with good plasma exposure in preclinical species and pharmacokinetic properties and supports once-a-day, oral dosage in humans.
These results indicate that EDP-323 is a potent RSV replication inhibitor, with a potential to be the best-in-class, once daily, oral antiviral treatment against the virus.
Enanta Pharmaceuticals senior vice-president and chief medical officer Scott Rottinghaus said: “Receiving fast track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations.
“Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window.
“We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Targets
Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.