Johnson & Johnson shares Phase 2 patient data for nipocalimab in Sjögren’s disease
Johnson & Johnson presented new patient‑experience results from the Phase 2 DAHLIAS study of nipocalimab in Sjögren’s disease. Exit interviews with 49 participants (30.1% of the 163‑patient trial) showed mouth dryness was the symptom patients valued most improving, with 96% citing it as a priority. The study also reported that at least a 50% increase in objective salivary flow was seen in 33% of patients receiving 15 mg/kg nipocalimab versus 16% on placebo at Week 24. Two Phase 3 trials are now underway and the drug holds FDA Breakthrough Therapy and Fast Track designations.
Why it matters
The positive Phase 2 outcomes and FDA designations may reduce regulatory risk for the upcoming Phase 3 programs, potentially enhancing the valuation of J&J’s autoimmune pipeline (the company notes the designations in its release).
Key facts
- 1Mouth dryness was reported as the most important symptom to improve by 96% of surveyed patients. prnewswire.com
- 2Fatigue was reported by 92% of surveyed patients as a core symptom. prnewswire.com
- 3Eye dryness was reported by 90% of surveyed patients as a core symptom. prnewswire.com
- 4Joint pain was reported by 73% of surveyed patients as a core symptom. prnewswire.com
- 5Vaginal dryness among women was reported by 49% of surveyed patients as a core symptom. prnewswire.com
- 673.5% of participants reported being satisfied or very satisfied with the study treatment. prnewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.