Amgen's Rare Autoimmune Disease Candidate Shows Improvement In Disease Burden In Treating Sjögren's Syndrome

Amgen Inc AMGN released new data from its Phase 2 study of dazodalibep for Sjögren's, a chronic (long-lasting) autoimmune disorder that happens when the immune system attacks the glands that make moisture in the eyes, mouth, and other parts of the body.

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The first patient population included patients with moderate to severe systemic disease activity as defined by an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.

Key findings include:

• Patients who transitioned from placebo to dazodalibep experienced an improvement in their disease activity from Day 169 (4.1-point reduction in total ESSDAI score) to Day 365 (6.3-point reduction).
• At Day 365, patients who transitioned to dazodalibep also showed greater improvements in ESSDAI response rate (3- to 4-point reduction), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score, and fatigue compared to those who transitioned to placebo.

The second patient population studied included those with moderate to severe symptomatology as defined by an ESSPRI score ≥5 and an ESSDAI score of <5.

• Patients who transitioned from placebo to dazodalibep experienced a further improvement in total ESSPRI score from Day 169 (0.5-point reduction) to Day 365 (1.3-point reduction).
• For patients who transitioned from dazodalibep to placebo, the improvements in total ESSPRI score achieved at Day 169 (1.8-point reduction) were largely sustained through Day 365 (1.9-point reduction).
• Patients who transitioned to dazodalibep also showed improvements in measurements of fatigue and the Patient Global Impression of Severity (PGI-S) from Day 169 to Day 365.

Dazodalibep was generally safe and well tolerated.