These are the first presentations of the Phase 2 trial results and are part of expert dialogue this week at the
The Company's Phase 2 trial of dazodalibep, a CD40 ligand antagonist in clinical development for Sjogren's syndrome, evaluated two patient populations; the first group included patients with moderate-to-severe systemic disease activity, and the second group included those with moderate-to-severe symptomatology including dryness, fatigue and pain despite lacking additional organ involvement. Results from the trial indicate treatment with dazodalibep may address the unmet therapeutic needs for this challenging condition, which has no approved disease-modifying therapies to date. Dazodalibep is the only investigational medicine to achieve the primary endpoint in both patient populations in a Phase 2 trial.
'The Phase 2 trial provides encouraging evidence that those suffering from Sjogren's could experience significant improvements of their disease with dazodalibep treatment,' said Wan-
Results in Patients with Moderate-to-Severe Systemic Disease Activity
The first population of the Phase 2 trial included patients with moderate-to-severe systemic disease activity as defined by a EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score of 5. The trial assessed changes in the ESSDAI score and other Sjogren's measures as well as safety of dazodalibep treatment compared to placebo.
Key findings include: The primary endpoint was achieved, and patients treated with dazodalibep experienced a statistically significant (p-value=0.0167) and clinically meaningful improvement in their disease activity (6.3-point reduction in their ESSDAI score) versus those who received placebo (4.1-point reduction) and showed positive trends in several other assessments at Day 169.
All ESSDAI responder analyses (pre-specified and post-hoc) favored dazodalibep over placebo, with greater numerical differences for the highest levels of response.
Patients treated with dazodalibep experienced numerically greater improvements in ESSPRI score and fatigue compared to those who received placebo at Day 169.
Safety profiles were similar between the groups, with the most commonly reported adverse events including COVID-19, diarrhea, dizziness, ligament sprain and upper respiratory infections.
Presentation Details
Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Subjects with Sjogren's Syndrome: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study
OP0143,
Results in Patients with Moderate-to-Severe Symptomatology
The Phase 2 trial also evaluated a second population of patients with moderate-to-severe symptomatology including dryness, fatigue and pain despite lacking additional organ involvement as defined by a EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score of 5, indicative of significant symptomatic burden and an ESSDAI score of
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