Scout | FOR-FD-24-007: Funding for stereochemically pure Inclisiran (LEQVIO) siRNA diastereomers: synthesis and activity assessment (preclinical only)

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grant FOR-FD-24-007

Funding for stereochemically pure Inclisiran (LEQVIO) siRNA diastereomers: synthesis and activity assessment (preclinical only)

Summary

This U01 supports research to synthesize each diastereomer of the GalNAc-conjugated siRNA drug Inclisiran (LEQVIO) and evaluate their biological activity. Projects will develop analytical methods and test PCSK9 inhibition in vitro and in animal models; clinical trials are not allowed. Results will inform sameness evaluations for generics and improve quality control for siRNA/oligonucleotide dr…

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo …

Funding Source

Agency: Food and Drug Administration

Awards & funding

Award Ceiling: $300,000

Award Floor: $300,000

Eligibility

Others (see text field entitled "Additional Information on Eligibility" for clarification)

Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

Public housing authorities/Indian housing authorities

Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Special district governments

Public and State controlled institutions of higher education

Small businesses

Independent school districts

Native American tribal organizations (other than Federally recognized tribal governments)

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH…

Supporting links

grants.gov

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