Amgen’s experimental drug, dazodalipeb, has demonstrated its potential as an effective first-in-class option for the treatment of Sjögren’s disease, as several companies race to break open the market with targeted therapies.
As per data from the Phase III OASIZ-301 study (NCT06104124) presented at a late-breaking session at the American College of Rheumatology (ACR) Convergence 2026, a 1,500mg, once-four-weekly dose of dazodalipeb offered a 1.8-point placebo-adjusted improvement in systemic disease activity after 48 weeks – though treatment benefits were seen as early as week four.
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Researchers found the same to be true for a once-12-weekly 3,000mg dose of the first-in-class CD40L antagonist fusion protein, which offered a 1.4-point reduction in disease activity at the 42-week timepoint. This means that both dosing regimens met the trial’s primary endpoint.
Meanwhile, patients in the 1,500mg dosing arm also experienced significant 1.17 and 0.93-point reductions in self-reported dryness from baseline, as measured by key Sjögren’s-specific scoring systems. This highlights the drug’s potential to address a symptom of Sjögren’s that Amgen calls “debilitating”.
On top of its efficacy, Amgen found dazodalipeb to be generally tolerable among the study population, with the most common adverse events being the common cold, urinary tract infections (UTIs), hypertension and infusion-related reactions. Patient discontinuations were also balanced across the placebo and treatment arms, while malignancy rates remained low and comparable across each group.
With these positive results in the bag, Amgen will now continue its broader Phase III programme for dazodalipeb in Sjögren’s disease. If successful, the drug could become the first CD40L-targeting therapy to reach the market, which currently has no approved targeted therapies.
Amgen added the drug to its pipeline as part of a near-$28bn takeover of Horizon Pharma in 2023. The deal also included Tepezza (teprotumumab), Krystexxa (pegloticase), and Uplizna (inebilizumab).
Sjögren’s disease, also known as Sjögren’s syndrome, is a chronic autoimmune condition that impacts the body’s moisture-producing glands – resulting in systemic dryness, fatigue and musculoskeletal pain. Researchers estimate that the disease impacts around 4 million people in the US.
The race to the Sjögren’s market continues
While Amgen is the latest to debut positive Phase III data for a Sjögren’s disease candidate, it is certainly not the only company vying for a place on this market.
Currently, there are several drugs in late-stage development for the condition, including Novartis’ anti-B-cell activating factor (BAFF)-binding therapy, ianalumab, which is currently under regulatory review by the US Food and Drug Administration (FDA) in this indication.
However, Jefferies analysts noted that dazodalipeb may have a leg-up on ianalumab based on systemic efficacy. “The dazodalibep data looks good as it produced a larger placebo-adjusted ESSDAI effect, with stronger statistical confidence, and maybe most importantly, significant patient-reported dryness benefits,” they commented.
As per cross-trial comparisons with different baseline characteristics, Jefferies analysts noted that the once-four-weekly 1,500mg dose’s 1.8-point improvement in systemic disease trumps ianalumab’s 1.0-1.3-point achievement in its respective Phase III trial – suggesting that dazodalipeb could be ahead in this sense.
“The difference is not enormous in absolute terms, but could be meaningful in a disease with substantial endpoint noise and placebo response,” the analysts added.
On top of this, RemeGen’s BLyS and APRIL-neutralising fusion protein, telitacicept, also recently posted a Phase III win during a Chinese Sjögren’s study.
