Amgen's Dazodalibep Succeeds in First Phase 3 Trial for Sjögren's Syndrome

Amgen's experimental drug dazodalibep has achieved success in the first of two Phase 3 trials for Sjögren's syndrome. The California biotechnology giant reported a 'statistically significant and clinically meaningful improvement' on a widely used measure of disease activity after 48 weeks, meeting the trial's primary objective.

The treatment showed positive effects as early as four weeks after administration and maintained these results through the evaluation period. Investigators did not observe an imbalance in blood clots or opportunistic infections, which was a potential concern with this class of drugs.

Sjögren's syndrome is a difficult-to-treat autoimmune disorder that affects moisture-producing glands, causing chronic dry eyes and mouth, pain, inflammation, and other health issues. Patients with Sjögren's have an increased risk of lymphoma.

Dazodalibep works by blocking the CD40-CD40L pathway, a key communication channel between immune cells. This approach has shown promise in earlier testing, where participants experienced a reduction in symptoms and disease activity.