Argenx Achieves Positive Vyvgart Results in Adapt Seron Study.

Argenx has reported positive results from the Adapt Seron study of its Vyvgart treatment for autoimmune diseases. Vyvgart is the first approved neonatal Fc receptor (FcRn) blocker and is being evaluated for its potential in multiple serious autoimmune diseases. The company is committed to improving the lives of people suffering from severe autoimmune diseases through its Immunology Innovation Program (IIP) and is advancing several experimental medicines within its therapeutic franchises.

Argenx (NASDAQ: ARGX), a global immunology company, announced positive topline results from its ADAPT SERON phase 3 study of VYVGART® (efgartigimod alfa-fcab) in patients with AchR-Ab seronegative generalized myasthenia gravis (gMG). The study achieved its primary endpoint with statistical significance (p=0.0068), demonstrating meaningful improvements in patients' daily living activities compared to placebo. This marks the first global phase 3 study showing clinical benefits across all three seronegative subtypes: MuSK+, LRP4+, and triple seronegative [1].

The ADAPT SERON study enrolled 119 adults with AchR-Ab seronegative gMG across North America, Europe, China, and the Middle East. Participants were randomized to receive either VYVGART or placebo, with the primary endpoint measuring improvements in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score from baseline to day 29 [1].

The study's positive results position Argenx to submit a Supplemental Biologics License Application (sBLA) to the FDA by the end of 2025, seeking expansion of the VYVGART label to include adult AChR-Ab seronegative gMG patients across all three subtypes – MuSK+, LRP4+, and triple seronegative. This potential label expansion could significantly broaden the addressable market for VYVGART, which is currently approved for AChR-Ab seropositive gMG patients [1].

VYVGART maintained its established safety profile with no new concerns identified, further strengthening its competitive position in the treatment landscape for myasthenia gravis. The consistent safety profile across seronegative subtypes is a critical factor in the drug's potential to become a foundational therapy for the broader MG population [1].

The ADAPT SERON study represents a significant breakthrough in the treatment of myasthenia gravis, particularly for the historically underserved population of AchR-Ab seronegative gMG patients. The study's findings validate Argenx's mechanistic approach targeting pathogenic IgGs as underlying drivers of gMG across all patient subtypes [1].

References:

[1] https://www.stocktitan.net/news/ARGX/argenx-announces-positive-topline-results-from-adapt-seron-study-of-ogpvuzfr98mp.html