Nurix Announces FDA Clearance of IND Application for GS-6791/NX-0479 – a Novel IRAK4 Degrader for Inflammatory Conditions

Collaboration partner, Gilead Sciences, to begin Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy volunteers in Q2 2025

GS-6791/NX-0479 has potential clinical applications across multiple blockbuster markets in inflammation, in both rheumatology and dermatology, including rheumatoid arthritis and atopic dermatitis

Nurix to receive a $5 million milestone payment from Gilead for FDA clearance of the IND, bringing the total amount received under the 2019 collaboration agreement to $135 million

Nurix is eligible for an additional $420 million in development, regulatory and commercial milestones associated with the IRAK4 degrader program as well as potential future royalties and retains an option to co-develop and co-detail in the United States with the parties splitting U.S. profits and losses

Excerpt from the Press Release:

SAN FRANCISCO, April 17, 2025 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, announced today that the U.S. Food and Drug Administration (FDA) has cleared the IND for the IRAK4 degrader GS-6791/NX-0479, enabling the initiation of a Phase 1 trial, which is anticipated to begin in Q2 2025.

“GS-6791/NX-0479 is a highly optimized, selective, oral degrader of IRAK4, a master regulator of IL-1R/TLR signaling pathways that plays a crucial role in inflammatory processes. IRAK4 has both kinase and scaffolding functions, thus complete pathway blockade requires an innovative approach like targeted protein degradation,” said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. “In preclinical studies, GS-6791/NX-0479 has demonstrated rapid and potent IRAK4 degradation across multiple human cell types in vitro, as well as rapid and sustained degradation in non-human primates. The ability to achieve complete IRAK4 degradation and cytokine suppression in disease-relevant tissues such as synovial fibroblasts and keratinocytes supports GS-6791/NX-0479’s potential as a best-in-class therapeutic. Additionally, GS-6791/NX-0479 has shown robust efficacy in rodent models of arthritis, supporting its potential to deliver superior therapeutic benefits for chronic inflammatory diseases including rheumatoid arthritis and atopic dermatitis.”

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