Johnson & Johnson’s FcRn inhibitor nipocalimab in a mid-stage study significantly improved disease activity across various organ systems in patients with the chronic autoimmune Sjögren’s disease.
Johnson & Johnson on Saturday posted promising data from the Phase II DAHLIAS study of its investigational FcRn blocker nipocalimab, demonstrating significant symptomatic improvement in patients with the chronic autoimmune Sjögren’s disease.
At 24 weeks, patients treated with nipocalimab saw a “statistically significant and clinically meaningful improvement” in the ClinESSDAI score, a composite scale specific for Sjögren’s disease that measures disease activity across 11 organ systems. Data were sparse but the pharma revealed that the improvement in ClinESSDAI scores had a p-value of 0.002 versus placebo.
In addition, patients showed response to nipocalimab as early as week 4 with the treatment effects persisting through 24 weeks of treatment.
Nipocalimab also elicited “clinically meaningful” improvements in key secondary endpoints including multiple organ and physician assessments, as well as other composite tools for clinical trial endpoints. DAHLIAS also recorded trends toward better outcomes in terms of important Sjögren’s disease symptoms, such as dryness of the eyes, mouth and vagina.
J&J presented these findings at a late-breaking session at last week’s 2024 Congress of the European Alliance of Associations for Rheumatology.
Terence Rooney, vice president of rheumatology at J&J, in a statement said that the data from DAHLIAS “demonstrate the potential of nipocalimab in a disease where patients have very few options,” noting that there is currently a “clear need” for “advanced therapies that target the underlying cause and systemic nature” of Sjögren’s disease.
Nipocalimab is an investigational monoclonal antibody that can bind with high affinity to FcRn receptor, which is commonly expressed in various cells of the immune system. This mechanism of action allows nipocalimab to lower circulating levels of IgG antibodies without triggering immune suppression and preserving the body’s overall immune function.
J&J secured access to nipocalimab in August 2020 when it dropped $6.5 billion to acquire Momenta Pharmaceuticals.
In addition to Sjögren’s disease, the pharma is testing nipocalimab in several immune-mediated indications. These include warm autoimmune hemolytic anemia, idiopathic inflammatory myopathy, rheumatoid arthritis and generalized myasthenia gravis.
In November 2023, J&J posted Phase IIa data for nipocalimab in moderate to severe rheumatoid arthritis demonstrating a significant reduction in circulating IgG antibodies, as well as numerical improvements in disease activity, treatment response and overall health.
In February 2024, the pharma released promising Phase III data for the investigational antibody in generalized myasthenia gravis. Nipocalimab treatment led to significant improvements in patients’ symptoms that affect their activities of daily living.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
