Amgen says dazodalibep met Phase 3 Sjögren's endpoint
OASIZ 301 met its systemic disease measure, but Amgen did not disclose the treatment gap; a second Phase 3 study is due to finish this year.
Adrian Kessler
A Phase 3 Sjögren's disease trial met its measure of systemic disease activity at Week 48, as Amgen Inc. NASDAQAMGN reported on Sept. 22 that dazodalibep succeeded in OASIZ 301. The planned study size was about 621 patients, but Amgen gave no treatment difference against placebo to show the size of the benefit.
The randomized, double-blind trial tested dazodalibep against placebo in adults with moderate-to-severe systemic disease. Its primary endpoint was the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index, or ESSDAI, which tracks disease activity across organ systems. Amgen did not disclose how many patients were enrolled or completed the primary assessment.
Amgen develops and sells medicines from its California base across inflammatory disease, cancer and other therapeutic areas.
Amgen shares traded at US$405.14 on Nasdaq at 12:14 p.m. EDT on Wednesday, according to the NASDAQAMGN quote. At 12:14 p.m. EDT on Wednesday, that NASDAQAMGN page showed a 1.24 per cent decline from the Sept. 22 close.
The Treatment Gap Remains Undisclosed
Amgen said ESSDAI improvement appeared by Week 4 and persisted through Week 48. The Sept. 22 release does not give either arm's mean score change, the difference between them, a p value or a confidence interval, so its description of a clinically meaningful benefit cannot yet be measured independently.
The company listed dryness, fatigue, joint symptoms and an ESSDAI response threshold among secondary measures, without reporting their outcomes. Those results will show whether the change in systemic activity extends to the symptoms that patients experience, and whether the primary result is consistent across measures.
Nasopharyngitis, urinary tract infection, hypertension and infusion reactions were more common with dazodalibep than placebo and occurred in at least five per cent of treated patients, Amgen said. Discontinuations due to adverse events were low and balanced between arms; the company reported no imbalance in thromboembolic events or opportunistic infections, but gave no arm-level event rates.
"Patients with Sjogren's disease contend with debilitating symptoms and systemic manifestations for which no approved disease-modifying therapy exists," lead investigator Ghaith Noaiseh, an associate professor of medicine at the University of Kansas Medical Center, said in Amgen's release.
Amgen's release does not describe any FDA agreement on the OASIZ 301 design or endpoint, and it gives no application date. The company plans to present detailed results at a medical meeting, but it has not named the meeting or set a presentation date.
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Amgen's Aug. 4 results reported US$3.5 billion in second-quarter free cash flow on US$10.1 billion of revenue. The Sept. 22 topline announcement supplied no cash runway estimate for dazodalibep.
Other Immunology Programs Face Their Own Tests
The closer disease peer, argenx SE NASDAQARGX, lists Sjögren's disease among the indications it is studying with efgartigimod. Novartis AG SWXNOVN NYSENVS names immunology as a core research area, placing Amgen's result in a wider pipeline of experimental autoimmune treatments.
State Street SPDR S&P Biotech ETF NYSEARCAXBI traded at US$155.35 at 12:20 p.m. EDT on Sept. 23. That sector price provides a market backdrop, although neither the fund quote nor Amgen's midday price establishes how investors value dazodalibep alone.
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OASIZ 303 studies patients with high symptom burden but low systemic activity, a different group from the adults in OASIZ 301. Amgen expects that Phase 3 trial to complete in the fourth quarter of 2026.
