J&J’s Nipocalimab Shows Promise in Sjögren’s Disease with Significant Phase 2 Results

1. Positive Phase 2 Results: Johnson & Johnson's nipocalimab has demonstrated significant efficacy in a Phase 2 study for Sjögren's disease, a chronic and debilitating autoimmune disease with no approved advanced treatments.
2. Statistical Significance: Patients receiving nipocalimab 15 mg/kg showed a greater than 70% relative average improvement on the primary endpoint compared to placebo, with a statistically significant p-value of 0.002.
3. Clinically Meaningful Improvements: The treatment group demonstrated improvements in secondary endpoints, including multiple organ assessments, physician assessments, and composite tools for clinical trial endpoints.
4. Mechanism of Action: Nipocalimab, an FcRn inhibitor, reduces levels of total IgG and autoantibodies associated with Sjögren's disease, consistent with its mechanism of action.
5. Future Development: The positive results support further clinical development of nipocalimab in Sjögren's disease, with plans to present full results at upcoming scientific medical congresses.