Amgen Inc. (NASDAQ: AMGN) has reported topline outcomes from its Phase 3 OASIZ 301 study, which evaluated the efficacy of dazodalibep in adult patients with Sjögren’s disease and moderate-to-severe systemic disease activity.
The study met its primary objective, demonstrating a statistically significant and clinically meaningful improvement in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) scores at 48 weeks. The company noted that improvements in ESSDAI scores were observed as early as Week 4 and were maintained through Week 48. The ESSDAI is a clinical instrument used to evaluate systemic disease activity across various organ systems in Sjögren’s disease patients.
Regarding safety, the rate of patients discontinuing treatment due to adverse events was low and similar between the treatment and placebo groups. There was no noticeable difference in the occurrence of thromboembolic events or opportunistic infections between the groups.
Amgen plans to share comprehensive data from the OASIZ 301 study at a future medical conference. The company also noted that the Phase 3 OASIZ 303 study, which assesses dazodalibep in patients with moderate-to-severe symptomatic Sjögren’s disease, is projected to conclude in the fourth quarter of 2026.
Analyst William Blair maintains a base case requiring two positive Phase 3 studies to support FDA approval for Sjögren’s disease (SjD). The analyst assumes Amgen will disclose next steps regarding regulatory discussions and potential filing plans following the OASIZ 303 readout.
