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
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Jan 15, 2024 12:00 AM
  4. 4
    Due Apr 8, 2024 12:00 AM
Description

The Food and Drug Administration (FDA) is offering a federal grant for the synthesis and biological activity assessment of different diastereomers in the siRNA drug LEQVIO (Inclisiran) through a clinical trial. LEQVIO is an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug used for inhibiting PCSK9 activity. The grant aims to understand the biological and pharmacological activity of each diastereomer in LEQVIO through controlled synthesis and biological activity assessment using in vitro and animal models. The research will focus on synthesizing each diastereomer in stereochemically pure form, assessing their biological activity, developing analytical methods to identify and characterize their structure, and evaluating their contribution to the overall pharmacological activity of LEQVIO. The knowledge gained from this research will also contribute to the evaluation of generic siRNAs and the quality control of oligonucleotide drugs. For more information, you can visit the funding opportunity announcement.

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