Nurix Therapeutics announced FDA clearance of the Investigational New Drug (IND) application for GS-6791/NX-0479, an IRAK4 degrader. This allows Nurix’s collaborator, Gilead Sciences, to initiate a Phase 1 clinical trial in healthy volunteers in Q2 2025. The drug candidate targets inflammation pathways relevant to diseases like rheumatoid arthritis and atopic dermatitis.
This IND clearance is a crucial step for Nurix, validating its targeted protein degradation platform and strengthening its partnership with Gilead. The advancement of GS-6791/NX-0479 into clinical trials signifies potential progress in addressing unmet needs within large patient populations suffering from inflammatory diseases. The successful initiation of the Phase 1 study could lead to a best-in-class therapy with superior efficacy compared to existing treatments.
Nurix received a $5 million milestone payment from Gilead for the IND clearance, bringing the collaboration’s total to $135 million. Nurix is also eligible for an additional $420 million in future milestones and retains co-development and co-detailing options in the US. The Phase 1 trial will evaluate single and multiple ascending doses in healthy volunteers. Preclinical data suggests the drug effectively degrades IRAK4, a key regulator of inflammatory responses.
This FDA clearance marks a pivotal point in the development of GS-6791/NX-0479, potentially paving the way for a novel therapeutic approach to inflammatory diseases. Positive Phase 1 results could significantly boost Nurix’s position in the field, attract further investment, and ultimately offer patients a much-needed new treatment option. The progress of this program also provides valuable insights into the broader applicability of Nurix’s targeted protein degradation platform for other therapeutic areas.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
