Nurix Therapeutics announces FDA cleared the IND for GS-6791/NX-0479

Nurix Therapeutics (NRIX) announced 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.”