Amgen is awaiting another Phase 3 readout for the investigational Sjögren’s disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.
Amgen’s investigational fusion protein significantly reduced disease activity in a Phase 3 study in Sjögren’s disease, setting the asset up to become what analysts say could be a “multi-billion-dollar franchise.”
The pharma didn’t provide specific data from the Phase 3 OASIZ 301 study, but said in a Tuesday release that the drug candidate dazodalibep met its primary endpoint of significantly improving systemic disease activity across various organs at 48 weeks. Improvements emerged as early as week four, the company said.
OASIZ 301 enrolled approximately 621 patients with moderate-to-severe systemic disease activity. Aside from disease activity, the trial also assessed fatigue and tender and swollen joints, among other secondary endpoints.
As for safety, Amgen reported that discontinuations due to adverse events occurred at a low rate and were similar across dazodalibep and placebo groups. The most common side effects were mild colds, urinary tract infection, hypertensio...