Atea Pharma's Investigational Dengue Treatment Fast Tracked In US

  • The FDA has granted Fast Track Designation for Atea Pharmaceuticals Inc's AVIR AT-752 for treating dengue virus infection.
  • AT-752, a novel, orally administered direct-acting antiviral derived from Atea's purine nucleotide prodrug platform, was designed for the treatment and prophylaxis of dengue. 
  • It works by impairing the dengue viral polymerase, inhibiting virus replication. 
  • AT-752 is in Phase 2 development and was generally well tolerated in the Phase 1 clinical study. In preclinical studies, AT-752 showed potent in vitro activity against all dengue serotypes and potent in vivo antiviral activity in a small animal model.
  • "Dengue is the most prevalent mosquito-borne virus affecting up to 400 million people annually and is a substantial public health and economic burden worldwide."
  • "We are advancing two proof-of-concept studies to demonstrate AT-752's safety and efficacy for the treatment and prophylaxis of dengue and look forward to initial data around the end of this year," said Janet Hammond, Chief Development Officer of Atea Pharmaceuticals.
  • Earlier this month, Atea said that following meetings with the FDA and the European Medicines Agency Emergency Task Force, Atea plans to initiate a global Phase 3 trial of bemnifosbuvir for COVID-19 in Q4 of 2022.
  • Price Action: AVIR shares are up 4.57% at $6.07 during the premarket session on the last check Monday.
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