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ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

Shots:

  • The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU)
  • The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials
  • In a Chinese study on pts aged 1–24 mos., ziresovir significantly reduced viral load, accelerated respiratory symptom resolution, & lowered the risk of recurrent wheezing and asthma over 24 mos. Findings were published in The NEJM & The Lancet Child & Adolescent Health

Ref: PRnewswire  |  Image: ArkBio  |  Press Release

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