AMGEN ANNOUNCES POSITIVE PHASE 3 RESULTS FOR DAZODALIBEP IN SJÖGREN'S DISEASE
Key Highlights
- ➤Both dazodalibep regimens met the Week 48 systemic disease activity endpoint
- ➤1,500 mg every four weeks reduced ESSDAI 5.6 points versus 3.8 placebo
- ➤3,000 mg every 12 weeks reduced ESSDAI 5.2 points versus 3.8 placebo
- ➤Every-four-weeks regimen significantly improved patient-reported dryness versus placebo
- ➤No FDA-approved Sjögren's disease treatments currently exist
Expert Statements
Jay Bradner, Executive Vice President, Research and Development, Artificial Intelligence and Data at Amgen
“These Phase 3 results support dazodalibep's potential as a first-in-class treatment for Sjögren's disease and strengthen the clinical rationale for targeting CD40L-mediated immune signaling in these patients.”
Jay Bradner, Executive Vice President, Research and Development, Artificial Intelligence and Data at Amgen
“In OASIZ-301, improvements in systemic disease activity were observed as early as Week 4 and sustained through Week 48.”
Jay Bradner, Executive Vice President, Research and Development, Artificial Intelligence and Data at Amgen
“We look forward to building on these findings as we advance a broader Phase 3 program.”
Ghaith Noaiseh, Associate Professor of Medicine at the University of Kansas Medical Center and Lead Investigator of the Study
“Sjögren's disease is complex and heterogeneous.”
Ghaith Noaiseh, Associate Professor of Medicine at the University of Kansas Medical Center and Lead Investigator of the Study
“People may experience dry eyes and mouth, fatigue and joint pain, as well as systemic manifestations affecting organs such as the lungs, kidneys or nervous system, underscoring the complexity of recognizing and managing the disease.”
Ghaith Noaiseh, Associate Professor of Medicine at the University of Kansas Medical Center and Lead Investigator of the Study
“In OASIZ-301, both dosing regimens reduced systemic disease activity compared with placebo, and the every four weeks regimen also improved patient-reported dryness.”
Ghaith Noaiseh, Associate Professor of Medicine at the University of Kansas Medical Center and Lead Investigator of the Study
“These results are encouraging and represent important progress in our effort to better address patients' unmet needs.”
Janet Church, President and Chief Executive Officer, Sjögren's Foundation
“For people living with Sjögren's disease, the need for new treatment options is significant, particularly given the wide-ranging and often debilitating impact of this disease.”
Janet Church, President and Chief Executive Officer, Sjögren's Foundation
“For our community, continued progress in research is important.”
Janet Church, President and Chief Executive Officer, Sjögren's Foundation
“The Sjögren's Foundation is encouraged by the momentum in Sjögren's research and hopeful that ongoing clinical development will lead to new treatment options that can help address the diverse needs of people living with Sjögren's disease.”
AMGEN ANNOUNCES POSITIVE PHASE 3 RESULTS FOR DAZODALIBEP IN SJÖGREN'S DISEASE PR Newswire
Only Global Phase 3 Trial to Show Clinically Meaningful Improvements in Systemic Disease Activity and Patient-Reported Symptoms of Sjögren's Disease
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