Horizon Says Phase 2 Trial Of Dazodalibep To Treat Sjögren's Syndrome Met Primary Endpoint
(RTTNews) - Horizon Therapeutics plc (HZNP) announced Monday that its Phase 2 trial evaluating dazodalibep for the treatment of Sjögren's syndrome met the primary endpoint in patients with moderate-to-high systemic disease activity. Sjögren's syndrome is a disease with no FDA-approved treatments available.
Dazodalibep is a CD40 ligand antagonist that blocks T cell interaction with CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway.
At Week 24, patients treated with dazodalibep achieved a 6.3-point reduction in their ESSDAI score and patients treated with placebo achieved a 4.1-point reduction.
In addition to the primary endpoint, numerical improvements were seen in key secondary, exploratory and post-hoc analyses. These included measures of dryness, which is an important symptom for patients living with Sjögren's syndrome as it impacts chewing, swallowing and dentition.
The trial was only powered for the primary endpoint. Dazodalibep was well tolerated in the trial.
The results from the Sjögren's trial follow positive results announced earlier this year from the Phase 2, randomized, double-blinded, placebo-controlled trial in rheumatoid arthritis patients.
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