DUBLIN - Horizon Therapeutics plc (Nasdaq: HZNP) today announced presentations of new results from the randomized, double-blind, placebo-controlled Phase 2 trial showing dazodalibep, an investigational treatment for Sjogren's syndrome, may improve some of the most prominent effects of this chronic, systemic autoimmune condition characterized by inflammation of exocrine glands.

These are the first presentations of the Phase 2 trial results and are part of expert dialogue this week at the EULAR European Congress of Rheumatology, May 31 - June 3, 2023, in Milan.

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-Fai Ng, Ph.D., study author and Professor of Rheumatology, Translational and Clinical Research Institute, Newcastle University, United Kingdom. 'The positive results represent a significant step towards developing a treatment for these patients.'

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, June 1, 11:35-11:45 a.m. CEST, South Hall, Session Room 2

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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