MILAN — An investigational protein drug called dazodalibep with broad-spectrum activity against autoimmune pathways reduced symptoms of Sjögren’s syndrome in a two-stage, phase II randomized trial with a unique design.
Called ALISS, the placebo-controlled trial targeted two different populations, each reported in separate presentations at the European Alliance of Associations for Rheumatology (EULAR) annual meeting. Dazodalibep is a non-antibody fusion protein that antagonizes the CD40 ligand, disrupting intercellular communication between different immune cell species that together drive autoimmunity in Sjögren’s syndrome.
The first, presented by Wan-Fai Ng, PhD, of Newcastle University in England, involved a fairly standard type of patient, those with moderate-to-severe overall symptoms as graded by the standard EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). With a primary endpoint of decline from baseline in ESSDAI score, 24 weeks of treatment led to a mean difference from placebo of 2.2 points (P=0.167).
Perhaps more interesting was the second stage, reported by Chiara Baldini, MD, of the University of Pisa in Italy. It targeted a patient group she described as “typically neglected” in Sjögren’s syndrome trials: those with relatively mild disease (ESSDAI score
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