Amgen Inc. (NASDAQ:AMGN) has reported encouraging topline outcomes from its Phase 3 OASIZ 301 study. The trial assessed the efficacy of dazodalibep in adult patients suffering from Sjögren’s disease accompanied by moderate-to-severe systemic disease activity.
Statistically Significant Improvements
The study met its primary objective, showing a statistically significant and clinically meaningful improvement at 48 weeks. The study quantified this improvement using the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
The positive effects of dazodalibep treatment on ESSDAI scores were noticeable as early as Week 4. These improvements were maintained consistently until Week 48 of the trial.
The ESSDAI is a recognized clinical instrument for evaluating systemic disease activity involving various organ systems in individuals with Sjögren’s disease.
Understanding Sjögren’s Disease
Sjögren’s disease is a comprehensive autoimmune condition that impacts the entire body.
It presents with symptoms like severe dryness, but it can also lead to other critical issues such as intense fatigue, persistent pain, involvement of major organs, neuropathy, and an elevated lymphoma risk.
Adverse Events and Future Plans
The rate of patients stopping the treatment due to adverse events was low and similar between the treatment and placebo groups, with no noticeable difference in the occurrence of thromboembolic events or opportunistic infections between the groups.
Amgen intends to share the comprehensive data from the OASIZ 301 study at a future medical conference.
Furthermore, the Phase 3 OASIZ 303 study, which examines dazodalibep in patients with moderate-to-severe symptomatic Sjögren’s disease, is projected to conclude in the fourth quarter of 2026.
Analyst View
William Blair continues to have a base case that two positive Phase 3 studies will be required to support FDA approval in SjD.
The analyst therefore assumes that Amgen will disclose next steps regarding regulatory discussions and potential filing plans after the OASIZ 303 readout.
Analyst Matt Phipps wrote, “We are encouraged by the positive result in OASIZ 301 given we viewed the dazodalibep SjD program as relatively high risk due to the historical difficulties in SjD drug development related to high placebo response rates and high patient heterogeneity in the indication.”
AMGN Price Action: Amgen shares were up 3.54% at $407.08 at the time of publication on Tuesday, according to Benzinga Pro data.
Image via Shutterstock/ Melnikov Dmitriy
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