Amgen's Sjögren's drug cuts disease activity in trial

Amgen reported detailed late-stage clinical trial data showing its experimental drug dazodalibep significantly reduced disease activity in patients with Sjögren's disease across 648 enrolled subjects. Both 1,500 mg monthly and 3,000 mg quarterly regimens met primary goals over 48 weeks. Meanwhile, phase III trials for ianalumab showed modest primary reductions with missed secondary endpoints. Sjögren's affects up to 4 million Americans, 90% women, with no approved US therapies.

Dazodalibep late-stage trial results

• ▪In Amgen's late-stage trial of 648 patients with moderate-to-severe Sjögren's disease, a 1,500 mg dose of dazodalibep every four weeks lowered disease activity scores by 5.6 points over 48 weeks, compared to 3.8 points for placebo
• ▪In Amgen's late-stage trial, patients taking a 3,000 mg dose of dazodalibep every 12 weeks achieved a 5.2-point reduction in Sjögren's disease activity, representing a 1.4-point improvement over placebo
• ▪Both tested dosing regimens of Amgen's dazodalibep met the primary trial endpoint for Sjögren's disease, showing significant therapeutic effects as early as week four of treatment

Ianalumab phase III trial results

• ▪Phase III trial results for ianalumab in Sjögren disease showed modest between-group differences compared with placebo and failed to meet key secondary endpoints
• ▪In the NEPTUNUS-2 trial of 504 patients, monthly 300 mg ianalumab decreased week-48 ESSDAI scores by 1.0 point more than placebo, whereas a 3-month dosing regimen failed to outperform placebo
• ▪In the NEPTUNUS-1 trial involving 275 patients, monthly treatment with 300 mg of ianalumab led to a 1.3-point greater decrease in ESSDAI score compared with placebo from baseline to week 48