Overview of Solicitation
The Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, has released a Request for Information (RFI)/Sources Sought Notice (SSN) titled “Host Directed Therapeutics for the Prevention of Progression to ARDS.”
This effort, in support of BARDA’s Influenza and Emerging Infectious Diseases Division (IEIDD), is intended to refine program requirements and inform future acquisition strategies for therapies that prevent progression to acute respiratory distress syndrome (ARDS) in patients with viral respiratory infections. The RFI is part of BARDA’s broader ARDS Preparedness and Response Program and reflects continued federal investment in host-directed approaches that improve outcomes in severe respiratory disease.
Project Scope and Eligibility
BARDA is seeking input from industry to support the advancement of host-directed therapeutics into late-stage clinical development, with a clear preference for candidates already in or approaching Phase 3 clinical trials.
The program is focused on hospitalized patients with viral respiratory infections who require supplemental oxygen and are at risk of progressing to ARDS. Proposed solutions should demonstrate the ability to prevent worsening of the disease and improve clinical outcomes in this population.
To be considered for future opportunities, respondents must meet several mandatory eligibility criteria, including:
- Data demonstrating a robust therapeutic mechanism of action relevant to severe disease due to influenza infection
- Demonstrated preclinical and/or clinical efficacy in reducing severe disease progression
- Relevance to viral respiratory infection, including influenza, through intended enrollment of appropriate patients
- Rationale behind dose selection for a Phase 3 study
- Evidence of FDA feedback and concurrence on study design for a proposed or ongoing Phase 3 study
Respondents to this RFI are asked to complete the following:
- Technical and programmatic questions outlined in the RFI Attachment A
- A technical capabilities statement
- Feedback on the draft Request for Project Proposals (RPP) via track changes (Attachment B)
BARDA anticipates making multiple awards under a future solicitation and may limit competition to organizations that respond to this RFI.
Respondents do not need to be members of the Rapid Response Partnership Vehicle (RRPV) consortium to submit to the RFI. However, consortium membership will be required to participate in any subsequent RPP.
Key Dates
- RFI Issued: April 1, 2026
- Responses Deadline: April 15, 2026, 3:00 PM (ET)
Responses should be submitted by email to [email protected].
Additional Information
This RFI is issued for information and planning purposes only and does not constitute a formal solicitation. Responses will be used to guide BARDA’s requirements development, acquisition strategy, and understanding of the current state of the science.
The inclusion of a draft RPP provides a valuable opportunity for industry to shape future program direction, influence technical requirements, and prepare for a potential follow-on funding opportunity.
This effort aligns with a growing federal focus on host-directed therapeutics, which are increasingly recognized for their potential to address multiple pathogens through shared biological pathways.
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