Description
The Biomedical Advanced Research and Development Authority (BARDA) is seeking information to refine the requirements for host-directed therapeutics for the prevention of progression to acute respiratory distress syndrome (ARDS) in support of BARDA's Influenza and Emerging Infectious Diseases Division (IEIDD). The project aims to advance the late-stage clinical development of host-directed therapeutics for the prevention of progression to ARDS in hospitalized patients with viral respiratory infection who require supplemental oxygen. The proposal should include a Phase 3 clinical development plan, including dose selection for a host-directed therapeutic product that has supportive Phase 2 data demonstrating efficacy in preventing worsening of severe disease in hospitalized patients with viral respiratory infection.
Key points to consider:
• BARDA is considering establishing long-term partnerships with multiple contractors.
• The information requested from this RFI will serve as market research and assist with requirements development.
• Proposed host-directed therapeutics must meet specific mandatory eligibility criteria, including demonstrating a robust therapeutic mechanism of action and preclinical and/or clinical efficacy against severe disease due to viral respiratory infection.
• Respondents are encouraged to provide feedback on the draft RPP via track changes.
• Responses should be submitted by email to [email protected] no later than 3:00 pm EDT on 15 April 2026.
Attached files
Contact
Laura Saddison