Enpatoran
- Generic Name
- Enpatoran
Merck's Enpatoran Shows Promise for Lupus Rash in Phase 2 Trial Despite Mixed Results
• Merck's oral TLR7/8 inhibitor enpatoran demonstrated clinically meaningful reduction in disease activity for patients with cutaneous lupus erythematosus and systemic lupus erythematosus with active lupus rash in the Phase 2 WILLOW study.
• The drug met its primary endpoint in Cohort A with up to 91.3% of patients achieving CLASI-50 response at Week 24, though it failed to meet the primary endpoint in the systemic lupus erythematosus cohort (Cohort B).
• As a potential first-in-class oral therapy targeting the TLR7/8 pathway, enpatoran could address significant unmet needs for lupus patients, with Merck now in discussions with health authorities regarding a global Phase 3 program.
FDA Grants Breakthrough Therapy Status to Radiprodil for GRIN-Related Seizure Treatment
• GRIN Therapeutics' radiprodil receives FDA Breakthrough Therapy designation for treating seizures in patients with GRIN-related neurodevelopmental disorder, showing 86% median reduction in seizure frequency during Phase 1b trials.
• The investigational drug demonstrated significant efficacy in Phase 1b Honeycomb study, with 71% of patients achieving over 50% reduction in countable motor seizures and most patients showing behavioral improvements.
• The company plans to initiate Phase 3 pivotal trials in mid-2025, backed by a $200M capital commitment from Blackstone Life Sciences, to evaluate radiprodil's impact on seizures and behavioral outcomes.
Drug Development Updates
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