Amgen’s Sjögren disease candidate succeeds in phase 3 trial, improving systemic symptoms

Amgen has confirmed the efficacy of its Sjögren disease candidate dazodalibep in a phase 3 trial.

According to Fierce Biotech on the 23rd, local time, Amgen announced that dazodalibep significantly improved disease activity compared with placebo in the phase 3 OASIS 301 trial involving 651 patients with moderate to severe Sjögren disease.

Sjögren disease is an autoimmune disorder in which the immune system attacks the tear and salivary glands. Dry eyes and dry mouth are its hallmark symptoms. There are currently no treatments specifically approved by the US Food and Drug Administration (FDA).

Dazodalibep is a fusion protein that targets CD40 ligand. After 48 weeks of treatment, the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) score improved significantly compared with the placebo group, meeting the primary endpoint.

The most common adverse events were mild or moderate nasal inflammation, urinary tract infections, hypertension and infusion-related reactions. Detailed results will be presented at a future scientific meeting.

Jay Bradner, Amgen’s executive vice president of research and development, said, “The rapid and sustained improvement observed in systemic disease activity strengthens confidence in dazodalibep.”

OASIS 301 enrolled patients with at least moderate symptoms and systemic disease. Another phase 3 trial, OASIS 303, is evaluating a patient population with similar symptoms but mild systemic disease activity.

In the Sjögren disease field, Novartis and Sanofi recently discontinued development programs. Novartis continues to develop the antibody ianalumab and achieved success in two phase 3 trials last year.

Astellas discontinued development of a STING inhibitor in April, and in May, Amgen also abandoned another candidate, adezivabat, acquired from Horizon, after it failed an interim analysis in a phase 2 trial.

Dazodalibep was not developed by Horizon; it is an asset Amgen obtained by acquiring Viela Bio, which was spun out of AstraZeneca in 2021, for $3 billion. Amgen acquired Horizon for $27.8 billion in 2023.