Amgen’s Sjögren’s syndrome drug succeeds in Phase 3 trial; shares jump 5%

Amgen’s experimental autoimmune disease treatment dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren’s syndrome.

According to BioPharma Dive on the 22nd (local time), Amgen said in a statement that treatment with dazodalibep led to a “statistically significant and clinically meaningful improvement” in disease activity at 48 weeks.

Treatment effects began to emerge after just 4 weeks of dosing and were maintained throughout the evaluation period. There was no imbalance in the incidence of blood clots or opportunistic infections, and adverse events were generally mild to moderate.

Sjögren’s syndrome is a difficult-to-treat disease in which the immune system attacks moisture-producing glands, causing chronic dry eyes and mouth, pain and inflammation. No approved treatment can yet alter the course of the disease.

Dazodalibep works by blocking CD40-CD40L, a signaling pathway between immune cells, to suppress excessive immune responses and autoantibody formation. In an earlier Phase 2 trial, it also reduced symptoms and disease activity.

The drug changed hands several times before reaching Amgen. AstraZeneca first developed it, followed by Viela Bio, which was acquired by Horizon Therapeutics in 2021. Amgen acquired Horizon two years later, gaining dazodalibep.

The results came from the first of two pivotal trials in Sjögren’s syndrome. Data from the second trial, which enrolled patients with a high symptom burden, are expected in the fourth quarter.

Detailed figures are expected to be presented at a future medical meeting, so the drug’s advantage over competitors remains unclear. Novartis’ ianalumab could receive regulatory approval this quarter, and Bristol Myers Squibb (BMS) is also expected to report Phase 3 data for its psoriasis drug Sotyktu in Sjögren’s syndrome.

David Risinger, an analyst at Leerink Partners, wrote that the detailed data Amgen releases “will help gauge its positioning” relative to ianalumab. Matt Phipps, an analyst at William Blair, said he was “encouraged” by the announcement, but noted that the patient populations in the two trials differ and that both studies will need to succeed for the drug to be approved.