Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
ID: 351809Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $300K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351809

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-011.html
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a funding opportunity (RFA-FD-24-011) for research focused on the synthesis and biological activity assessment of different diastereomers in the FDA-approved siRNA drug LEQVIO (Inclisiran). The primary objective of this cooperative agreement is to systematically evaluate the diastereomeric composition of LEQVIO, including the synthesis of each diastereomer in stereochemically pure form and the assessment of their biological activity in inhibiting PCSK9 using in vitro assays and animal models. This research is significant as it aims to enhance the understanding of siRNA drugs, contribute to the development of generic siRNAs, and ensure quality control of oligonucleotide drugs. The total funding available for this opportunity is $300,000, with applications due by March 31, 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-011.html
    The Department of Health and Human Services, via the FDA, has announced a new funding opportunity (RFA-FD-24-011) for the assessment of diastereomeric compositions in the FDA-approved siRNA drug LEQVIO (Inclisiran). The objective is to evaluate the biological activities of each diastereomer through systematic synthesis, in vitro assays, and animal models. The study aims to develop analytical methods for characterizing stereochemical structures, assess the potency of each diastereomer in inhibiting PCSK9, and understand their contributions to the drug's overall efficacy. With a total budget of up to $300,000 for FY 2024, the opportunity is open to various eligible scientific organizations and institutions. Key submission deadlines include January 15, 2024, for the open date and March 31, 2024, for application submissions. This research will enhance understanding of siRNA drugs and support generic product development, ensuring quality and accessibility for patients. The cooperative agreement emphasizes collaboration between award recipients and FDA scientists throughout the research process, highlighting significant federal involvement. The results are intended for publication and public data sharing, subject to FDA review, to facilitate advancements in the field of therapeutic siRNA drug development.
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