Johnson & Johnson (J&J) has shared positive phase 2 results of its investigational anti-FcRn antibody, nipocalimab, in Sjögren’s disease (SjD), a chronic autoimmune disease.
The DAHLIAS dose-ranging study has been evaluating the effects of nipocalimab in 163 adult patients living with primary SjD, including adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies.
Affecting an estimated four million people worldwide, SjD is a prevalent autoantibody-driven disease that is characterised by chronic inflammation and lymphocytic infiltration of the exocrine glandular systems, for which there are no therapies currently approved.
Terence Rooney, vice president, rheumatology, immunology and disease area leader, J&J Innovative Medicine, commented: “A clear need exists for patients living with SjD to have advanced therapies that target the underlying cause and systemic nature of this disease, as none have been approved to date.”
Representing the first positive results in SjD for nipocalimab, the investigational antibody achieved both its primary and secondary endpoints in SjD patients versus placebo.
The investigational antibody demonstrated a statistically significant and clinically meaningful improvement in ClinESSDAI score, which measures disease activity across 11 organ systems, in SjD patients versus placebo at 24 weeks compared to baseline and demonstrated improvements in SjD symptoms at week 24, with the safety and tolerability being consistent with other clinical studies.
“This data establishes proof of concept for nipocalimab in SjD and supports further clinical development,” said study investigator, professor Jacques-Eric Gottenberg, department of rheumatology, Strasbourg University Hospital, National Centre for Rare Systemic Autoimmune Diseases.
As part of its nipocalimab programme, J&J has been running several clinical trials, including phase 3 studies evaluating the antibody in generalised myasthenia (gMG), chronic inflammatory demyelinating polyneuropathy and warm autoimmune haemolytic anaemia.
In February, the company shared positive top-line results from the phase 3 VIVACITY study of nipocalimab in adults with gMG, a chronic autoimmune disorder that affects approximately 700,000 people worldwide.
Nipocalimab achieved its primary endpoint, demonstrating a statistically significant reduction in MG-ADLa score, an assessment of symptoms that affect the daily lives of patients, from baseline over weeks 22 to 24 compared with placebo.