HZNP - Horizon says auto-immune disease candidate met another main goal in phase 2 trial

Horizon Therapeutics ( NASDAQ: HZNP ) announced Wednesday that dazodalibep, a candidate for autoimmune disease Sjögren’s syndrome, met the primary endpoint for the second population in a Phase 2 trial.

In September, the company said that dazodalibep also met the primary endpoint in the first study population targeting the moderate- to-high systemic disease.

The second study population comprised 109 patients with moderate-to-severe subjective symptoms, including dryness, pain, and fatigue.

In that group, dazodalibep-treated patients outperformed the placebo group at Day 169, achieving a 1.8-point reduction in ESSPRI scores, an indication of the symptomatic burden, compared to a 0.53-point decrease in the placebo group.

Additionally, the company said that there were statistically significant results for certain secondary quality-of-life measures such as fatigue, and the study drug was well tolerated, with the commonest adverse events being COVID-19, nasopharyngitis, and anemia.

Horizon ( HZNP ) expects to share the results with the FDA to design a Phase 3 trial which is scheduled to begin in 2023, earlier than the previous timeline.

In December, Amgen ( NASDAQ: AMGN ) agreed to acquire Horizon Therapeutics ( HZNP ) for nearly $28B in cash.

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