OVERVIEW
Anti-viral therapies are a critical medical countermeasure against acute viral infections and their long-term sequelae. For many viruses, such as filoviruses, the commercial market provides limited incentives for product developers to evaluate promising candidates. Antiviral therapeutics are generally advanced for a single indication, however they may have efficacy against multiple related viruses due to conserved mechanisms and host/virus proteins.
With the Repurposing Drugs for Biological Threats (ReBooT) program, DRIVe and BARDA's Antivirals and Antitoxins (AVAT) branch aim to support the testing and evaluation of candidate antiviral therapeutics that have been licensed or developed past Phase 1 clinical trials for another indication, but which have a mechanism of action likely to be effective against filoviruses.
APPROACH
Drug repurposing, or label expansion, is a strategy that is used to identify new uses for approved or late-stage therapeutics beyond their original clinical indication. With ReBooT, efforts are focused on repurposing safe direct-acting and host-directed therapeutics that have the potential to reduce the mordidity and mortality associated with filovirus infection.
Program funding will support proof of concept studies and help fill critical knowledge gaps to include:
- Identifying candidates that can be repurposed, either licensed or beyond Phase 1, with a mechanism of action suggestive of efficacy against the filoviruses
- Supporting critical evaluations to determine if the candidate warrants future consideration for product development
Program Goals
Repurpose Promising Drugs
Licensed or late-stage (beyond Phase 1) therapeutics with the potential to complement existing therapies or serve as effective monotherapies against filoviruses.
Support Critical Proof-of-Concept Studies
Preclinical efficacy studies in animal models of filovirus disease will be the primary focus; CMC safety/toxicity or other studies that will facilitate evaluation of the drug will also be considered.
Transition Successful Candidates
Outcomes could guide follow-on funding considerations under Advanced Research and Development programs.
PROGRAM SPECIFIC FAQ
What is within scope of the ReBooT program?
BARDA is requesting abstract submissions for projects that evaluate existing therapeutics as medical countermeasures (MCM) against filoviruses. The candidates should be direct acting anti-virals or host directed products.
The ideal therapeutic should have the potential to complement existing therapies by improving patient outcomes or serve as effective monotherapies against filoviruses.
Broad spectrum antivirals with anticipated efficacy against multiple species or genera of viruses are preferred.
Also, products that are orally available and have room temperature storage will be preferred.
What are the ideal characteristics of a therapeutic that is eligible for ReBooT funding?
Should have a known and acceptable safety and toxicology profile as evidenced by Phase 1 results OR licensed for another clinical indication and have the potential to undergo label expansion.
A drug with in vitro and/or in vivo efficacy data against filoviruses and/or a mechanism of action that is anticipated to have efficacy against filoviruses.
Should have the potential to complement existing therapies to improve patient outcomes or serve as effective monotherapies against filoviruses.
Freedom to operate for other indications.
What types of abstracts/proposals is the ReBooT program looking for?
The ReBooT program will primarily focus on proposals for preclinical efficacy studies (i.e. efficacy in animal models of filovirus disease); such proposals should clearly delineate the:
- Proposed study design;
- Laboratory partners, if required;
- Outcome measures; and
- Proposed threshold for study success, which could guide go/no go decisions for follow on funding;
Proposals focusing on chemistry manufacturing and controls (CMC) activities, safety/toxicity, or other studies that will facilitate evaluation of the product as a viable candidate to treat filovirus infection will also be considered.
What is out of scope for the ReBooT program?
Drugs with Phase 1 failures or withdrawn from market for safety reasons.
Development of vaccines.
Is the ReBooT program supporting vaccine development for filoviruses or other viruses?
No
Is this funding opportunity open to to academics or do only companies qualify?
It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions.
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov
Can companies/universities outside of the United States apply for DRIVe funding?
Yes
Do academic institutions also need to provide a 30% cost share?
Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50%, unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners under the DRIVe EZ-BAA have been awarded a contract that does not include a cost-share component range, including all universities and non-profit organizations. Cost-share may be in-kind or cash contributions. It may also come from a third-party investor/sponsor, however it is up to you to ensure you receive their contribution toward the proposed project. Many organizations offer to cover Overhead or Fringe Benefits. Some also offer pro-bono labor hours or sponsored equipment, materials, or subcontractor costs. A combination of all of the above could be acceptable. It would need to be indicated on a submission what is being cost-shared. To qualify for no cost-share under an EZ-BAA award, a respondent must show that there is "no probability that the respondent will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303". Examples of present or future benefits include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market, and use of background knowledge of future contracts.
What are the data sharing requirements of this program?
Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.
The EZ-BAA application is so short. Can I include links to figures or references?
While you can include links to figures or references, it is not mandated that reviewers view that outside information. At this time, the abstract format does not accept any figures, only text.
Looking for General FAQ?
ReBooT program is open until May 31, 2024