Argenx has terminated a late-stage trial evaluating its marketed therapy, Vyvgart Hytrulo (efgartigimod alfa, hyaluronidase-qvfc) in Sjögren’s syndrome – dashing the drug’s hopes of a label expansion in this indication.
The Dutch biotech made the call to discontinue the Phase III UNITY study (NCT06684847) based on recommendations from the trial’s independent data monitoring committee (IDMC), which – after an interim analysis – deemed it unlikely that the trial would meet its study’s primary goal.
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Before its early end, UNITY was evaluating Vyvgart Hytrulo, a subcutaneous formulation of the original neonatal Fc receptor (FcRn) antagonist, Vyvgart, in adults with moderate-to-severe Sjögren’s disease. Researchers observed no new safety signals linked to treatment with Vyvgart Hytrulo in this study.
The results of the UNITY trial come in contrast to those of the open-label Phase II RHO+ study (NCT06203457), in which patients treated with Vyvgart experienced low disease activity at the 72-week mark.
Vyvgart Hytrulo, a neonatal Fc receptor (FcRn) antagonist, is currently approved by the US Food and Drug Administration (FDA) for the treatment of neurological disorders, generalised myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). To expand the drug’s horizons across the immunology treatment landscape, Argenx is currently conducting several clinical studies on Vyvgart and Vyvgart Hytrulo across rheumatological diseases like systemic sclerosis, endocrinological conditions like Graves disease and haematological disorders such as immune thrombocytopenia.
Following this disappointing outcome, Argenx will now analyse the data generated from UNITY to better understand the outcome of the study, while generating new insights that could benefit future research in the Sjögren’s disease space. According to Argenx’s CMO, Luc Truyen, Sjögren’s syndrome is “one of the most heterogeneous and complicated diseases” to treat in the immunology space.
Sjögren’s disease landscape on the cusp of new therapies
Currently, there are no approved disease-modifying therapies (DMTs) for Sjögren’s disease, which researchers estimate impacts around 300 million patients globally. While biologics like Biogen and Roche’s Rituxan (rituximab) and GSK’s Benlysta (belimumab) are sometimes used off-label for patients with high disease activity or organ involvement, neither is specifically indicated for use in Sjögren’s syndrome.
However, there are now several drugs in late-stage development for Sjögren’s, which could break the prior treatment drought seen within the disease.
This includes Novartis’ ianalumab, which has already secured a duo of Phase III wins in this condition through the NEPTUNUS programme (NCT05350072; NCT05349214), which led the Swiss pharma giant to tee up the possibility of US regulatory submissions within Sjögren’s syndrome.
Novartis is not the only player eyeing the Sjögren’s market, however, as Amgen is also in the throes of Phase III testing for its therapy, dazodalibep – with the OASIZ 301 trial (NCT06104124) recently netting a positive outcome.
Meanwhile, Vor Bio and RemeGen achieved similarly positive outcomes for their candidate, telitacicept, in a late-stage study conducted in China (NCT05673993), though the drug’s wider global commercial potential will hinge on it demonstrating efficacy in the ongoing US-based Phase III programme.
