Horizon Therapeutics' Lupus Candidate Flunks Mid-Stage Study

Horizon Therapeutics plc's HZNP Phase 2 trial evaluating daxdilimab for Systemic Lupus Erythematosus (SLE) did not meet the primary endpoint.

SLE is an autoimmune disease in which the immune system attacks its tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels.

The study failed to show a statistically significant separation between daxdilimab and placebo on the proportion of patients to achieve a British Isles Lupus Assessment Group (BILAG) 2004 Index-based Combined Lupus Assessment (BICLA) response and an oral glucocorticoid (OGC) dose of ≤7.5 mg/day (prednisone equivalent), which represented a reduction from the Baseline OGC dose at 48 weeks. 

BICLA is a composite measure indicating low SLE disease activity. Numerical differences were seen in other endpoints. 

No safety concerns were reported.

Also Read: FTC Files Lawsuit To Stop Amgen Buying Horizon Therapeutics, Sending Shockwaves Through Biopharma M&A.

"While we are disappointed that the trial did not meet its primary endpoint, we will continue to work with investigators to assess these data to determine the next steps for our SLE clinical program," said Elizabeth H.Z. Thompson, executive vice president of research and development, Horizon.

Price Action: HZNP shares are down 0.42% at $100.75 premarket on the last check Monday.