Nurix Announces FDA Clearance for GS-6791/NX-0479, a Novel IRAK4 Degrader for Inflammatory Conditions
Thursday, April 17, 2025
Nurix Therapeutics, a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for GS-6791/NX-0479. This marks a significant step towards initiating a Phase 1 clinical trial, which is expected to commence in the second quarter of 2025.
GS-6791/NX-0479 is a highly selective, oral degrader of IRAK4, a key regulator in inflammatory processes. IRAK4 plays a pivotal role in the IL-1R/TLR signalling pathways, crucial to the body’s immune response. Because of its dual functions—both as a kinase and scaffolding protein—disrupting IRAK4 effectively requires an advanced approach such as targeted protein degradation.
Preclinical studies have shown that GS-6791/NX-0479 can rapidly and effectively degrade IRAK4 in various human cell types in vitro, and it maintains potent degradation in non-human primates. This ability to target IRAK4 degradation in relevant tissues, such as synovial fibroblasts and keratinocytes, highlights its potential as a leading therapeutic option for chronic inflammatory conditions. Furthermore, the compound has demonstrated strong efficacy in rodent models of arthritis, supporting its possible use in treating rheumatoid arthritis and atopic dermatitis.
The announcement further underscores the successful collaboration between Nurix and Gilead Sciences, showcasing Nurix’s capability to advance targeted protein degradation therapies for patients with autoimmune and inflammatory diseases. GS-6791/NX-0479 is part of Nurix’s expanding pipeline, which also includes therapies such as a STAT6 degrader developed in collaboration with Sanofi and a proprietary BTK degrader, NX-5948, intended for inflammatory and autoimmune conditions.
In June 2019, Nurix and Gilead entered a global strategic partnership to discover, develop, and commercialise a pipeline of targeted protein degradation therapies, including up to five treatments for challenging diseases. Nurix has already received substantial funding, including an upfront payment of $45 million, with potential future milestones totalling up to $420 million for the IRAK4 programme. Nurix also retains the option to co-develop and co-detail certain programmes in the U.S., splitting development costs and profits equally with Gilead.
GS-6791/NX-0479 represents a significant step forward in the treatment of inflammatory diseases, with its promising potential to address conditions like rheumatoid arthritis through the innovative approach of targeted protein degradation. Gilead is responsible for advancing this programme through clinical development.
Source: globenewswire.com
