Amgen Experimental Drug Shows Symptom Reductions in Chronic Autoimmune Disease That Impacts Tears

Amgen Inc. (NASDAQ:AMGN) announced positive Phase 3 results showing dazodalibep significantly reduced systemic disease activity and key symptoms in patients with Sjögren’s disease, a chronic autoimmune disease in which the immune system mistakenly attacks the body’s moisture-producing glands.

The OASIZ-301 trial is the only global Phase 3 study to show clinically meaningful systemic improvements in this heterogeneous autoimmune condition, which currently lacks U.S. Food and Drug Administration-approved treatments.

Amgen presented the full data during a late-breaking session at ACR Convergence 2026, a six-day event ending Wednesday, Nov. 11.

Significant Reductions In Systemic Disease Activity

In the randomized, double-blind study, enrolled patients presented with an average baseline score of 10.2 on the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI).

Both dazodalibep treatment groups met the primary endpoint at Week 48, showing statistically significant reductions in systemic disease activity compared to placebo.

Patients who received 1,500 mg every four weeks achieved a 5.6-point least-squares mean drop from baseline in ESSDAI scores versus 3.8 points for placebo.

A 3,000 mg regimen given every 12 weeks generated a 5.2-point reduction versus 3.8 points for placebo. Symptom improvements began as early as Week 4 and persisted through Week 48.

In addition, more participants on dazodalibep reached meaningful score reductions of at least 3, 5, or 7 points.

Meaningful Gains In Dryness And Systemic Domains

The 1,500 mg regimen also significantly improved patient-reported dryness, relieving a debilitating symptom that frequently accompanies persistent fatigue and pain.

Placebo-adjusted score changes reached -1.17 points on the ESSPRI dryness domain and -0.93 points on the DASPRI dryness index. Both treatment arms delivered overall ESSPRI score improvements exceeding 1.5 points.

Furthermore, dazodalibep drove consistent responses across constitutional, articular, glandular, and other systemic domains. A higher percentage of treated patients met composite STAR response criteria and exhibited enhanced stimulated salivary flow.

What’s Next

Amgen is also evaluating the therapy in the Phase 3 OASIZ-303 trial for patients with high symptom burden and low systemic activity, alongside the OASIZ-304 long-term extension study.

AMGN Price Action: Amgen shares were down 1.12% at $460.00 during premarket trading on Wednesday, according to Benzinga Pro data.

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