Why it matters: The setback closes off the current pivotal development path for expanding Vyvgart into another autoimmune disease. It also reverses encouraging early findings in Sjögren’s, although the company reported no new safety signals.
How it works: Efgartigimod blocks the neonatal Fc receptor, reducing circulating IgG antibodies, including those that attack the body’s own tissues. Marketed as Vyvgart and Vyvgart Hytrulo, it already treats generalized myasthenia gravis and, in its subcutaneous formulation, chronic inflammatory demyelinating polyneuropathy.
Zoom in: An independent data monitoring committee recommended stopping UNITY for futility. The placebo-controlled study tested weekly subcutaneous efgartigimod in adults with moderate-to-severe Sjögren’s disease who tested positive for anti-Ro/SSA autoantibodies.
- Its primary endpoint measured changes in systemic disease activity at week 48. Argenx has not disclosed the treatment difference or detailed interim results, leaving the reasons behind the failure unclear.
- Sjögren’s is a chronic autoimmune disease that damages glands and can affect other organs. Common symptoms include dry eyes and mouth, fatigue and joint pain.
What they’re saying: “We are disappointed by this outcome, most of all for people living with Sjögren’s disease, who are still waiting for treatments that fundamentally change the course of their disease,” said Luc Truyen, argenx’s chief medical officer.
The context: Argenx had expected UNITY results in the second half of 2027. Its earlier Phase 2 RHO trial enrolled just 34 patients, and the company presented extension data in June suggesting sustained responses.
- The early termination therefore removes a future growth opportunity sooner than expected. TD Cowen analysts had anticipated positive Sjögren’s data in 2027, according to Fierce Biotech, illustrating the expectations surrounding the program before today’s announcement.
Also notable: Argenx simultaneously reported that FB102 met its primary endpoint in a Phase 2 celiac disease trial. The antibody blocks CD122, a component of immune signaling pathways involving IL-2 and IL-15, a different mechanism from efgartigimod.
- The study enrolled 126 adults whose disease was controlled on a gluten-free diet. Participants received one of two intravenous FB102 doses or placebo while undergoing an eight-week gluten challenge.
- FB102 significantly improved a measure of intestinal tissue structure versus placebo at day 78 (p=0.0176). Argenx said symptom and inflammatory measures supported the primary finding, with no new safety signals.
Yes, but: The release did not disclose the size of the treatment benefit or detailed symptom results. Those data will be presented at a future medical meeting.
- Argenx acquired FB102 through its purchase of Forte Biosciences, completed in August, following a deal announced at $2.2 billion (€1.9 billion). The asset adds another potential source of growth beyond Vyvgart.
- As Karen Massey, CEO of argenx, explain in an interview to European Biotechnology, “With Forte, we found a molecule that fits our formula: novel science addressing autoimmune diseases with high unmet need. We thought, ‘that looks like an argenx molecule,’ so we moved quickly to secure it.”
What’s next: Argenx plans to move FB102 into Phase 3 and continues evaluating it in vitiligo and alopecia areata. For UNITY, the company will analyze the full dataset after study closure and database lock to understand why the earlier promise failed to translate.
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