PFE - Enanta RSV therapy EDP-323 gets FDA track status

2023-04-06 07:25:43 ET

• The U.S. Food and Drug Administration (FDA) granted fast track designation to Enanta Pharmaceuticals' ( NASDAQ: ENTA ) EDP-323 to treat respiratory syncytial virus (RSV).
• The company is evaluating EDP-323 in a phase 1 trial and expects to report topline data this quarter.
• Enanta plans to present new preclinical pharmacokinetics (PK) data at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April.
• "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," said Enanta's Senior Vice President and Chief Medical Officer Scott Rottinghaus.
• The RSV vaccine space is heating up with the two pharma heavyweights, GSK ( GSK ) and Pfizer ( PFE ), competing intensely. Both companies saw FDA panel's greenlight for their respective RSV candidates for older adults, with the agency's main decision expected in May. The two companies have been preparing for rolling out the vaccines this year.

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