Amgen's Phase 3 Trial for Sjögren's Syndrome Hits Primary Endpoint, Filling Gap With No Approved Therapies
nashnova research
Amgen's experimental drug dazodalibep met the primary endpoint in a Phase 3 Sjögren's disease trial — a condition with zero FDA-approved therapies — sending shares higher pre-market.
Why does this disease matter?
Sjögren's disease — an autoimmune condition where the immune system attacks the body's own glands, causing severe dryness and organ damage — currently has no FDA-approved treatment in the United States.
This means → patients rely entirely on symptom relief; nothing targets the underlying disease.
If dazodalibep ultimately wins approval, it would be the first-ever approved drug for Sjögren's — a zero-to-one moment for both Amgen and patients.
What exactly did the trial show?
The OASIZ 301 Phase 3 study enrolled over 600 patients with moderate-to-severe disease and ran for 48 weeks, hitting its primary endpoint.
That endpoint was a statistically significant and clinically meaningful improvement in the ESSDAI score — a tool that measures systemic disease activity across multiple organs.
In plain terms = the benefit was not just a number on paper; doctors and patients could see real improvement, as early as week 4.
How did the safety profile look?
The most common side effects were nasopharyngitis and urinary tract infections — typical for autoimmune drugs.
Discontinuation rates due to adverse events were low and balanced across treatment groups.
This means → no unexpected red flags emerged, removing a potential hurdle for the regulatory filing ahead.
What comes next?
Amgen said it will present full OASIZ 301 data at a future medical conference — today's release covers top-line results only.
A second Phase 3 trial, OASIZ 303, targets the same patient population and is expected to read out in Q4 2026.
This reflects Amgen's two-trial strategy: whether 303 replicates 301's results will directly shape the pace and strength of its regulatory submission.
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