Amgen's Dazodalibep Meets Phase 3 Goal in Sjögren's as Full OASIZ-301 Data Arrive

AMGN released the full results of OASIZ-301, the first Phase 3 study of dazodalibep in Sjögren's disease, on Wednesday, confirming that the experimental drug met its late-stage goal. Both regimens tested, 1,500 mg every four weeks and 3,000 mg every 12 weeks, met the primary endpoint at Week 48, producing statistically significant reductions in systemic disease activity compared with placebo as measured by the ESSDAI index, according to Amgen's release. The randomized, double-blind, placebo-controlled trial enrolled 648 patients with moderate-to-severe systemic disease.

Dazodalibep is a CD40L antagonist fusion protein, and the every-four-weeks dose also improved patient-reported dryness, one of the hallmark symptoms of the disease (BioPharm International). Amgen said serious adverse events and discontinuations due to adverse events were balanced across the three treatment groups (Amgen). Investor's Business Daily framed the readout as putting Amgen in position to have one of the first immune-modulating treatments for Sjögren's.

The full data build on the topline result Amgen first announced on Sept. 22, so Wednesday's release adds detail rather than a new verdict. The open question is size: in Phase 2 the drug cut ESSDAI by 6.3 points versus placebo, and investors will compare the Phase 3 effect against that bar and against Novartis' ianalumab, a rival Sjögren's candidate; in September Citi said it wanted more data before judging the two (Reuters via WHBL).

What to watch: results from the second Phase 3 study, OASIZ-303, which has not yet reported, and any filing timeline, which the release did not give. Analysts have said two positive Phase 3 studies will likely be needed for FDA approval, which makes the second readout the next real catalyst for the program.