Argenx presents Vyvgart and ARDA data at AANEM meeting, MGFA sessions

Argenx announced the presentation of clinical and real-world data across its growing immunology pipeline at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine, or AANEM, annual meeting and Myasthenia Gravis Foundation of America, or MGFA, Scientific Sessions in Savannah, Georgia from October 15-18. The data presented at AANEM continue to demonstrate the significant impact of Vyvgart, the first-in-class neonatal Fc receptor blocker for people living with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. Vyvgart is setting a new treatment standard in gMG and has shown rapid, deep and sustained responses, enabling a majority of patients to achieve minimal symptom expression with a consistent and favorable safety profile and more than 8,000 patient years of safety data. Based on real-world data, more than half of patients can reduce steroid use by greater than5mg/day following Vyvgart initiation. In CIDP, a majority of patients in the ADHERE trial responded to Vyvgart Hytrulo and experienced reduced risk of relapse versus placebo and improvements in motor function and muscle strength, regardless of prior CIDP treatment. Vyvgart demonstrates consistent improvement across gMG patient subtypes, including those on mestinon alone, indicating its efficacy in early line use. Real-world gMG data show that at one-year post Vyvgart initiation, 55% of patients reduced corticosteroid use by greater than or equal to 5 mg/day and 42% of patients had achieved steroid doses of less than or equal to5mg/day. Argenx is honoring its long-term commitment to the broader MG community with two Phase 3 studies ongoing in additional MG patient populations, including seronegative and ocular MG. Seronegative gMG patients evaluated in Vyvgart clinical studies experienced consistent and clinically meaningful MG-ADL improvements, including patients achieving MSE. Vyvgart Hytrulo showed sustained functional benefit in motor function and muscle strength, regardless of prior treatment, which was maintained through ADHERE and the open-label extension study. Vyvgart’s consistent and favorable safety profile has been established across multiple autoimmune diseases with no increase in the incidence of adverse events with increased exposure. The unique safety profile of Vyvgart is further supported by no black box warnings, no labs or immunoglobulin monitoring, and no vaccination requirements. Argenx will also highlight two additional pipeline candidates, including Phase 2 ARDA data of empasiprubart for the treatment of multifocal motor neuropathy, and clinical trial designs of ARGX-119 (muscle-specific kinase for the treatment of congenital myasthenic syndromes and amyotrophic lateral sclerosis. Cohort 1 data from the Phase 2 ARDA study will be presented in a poster, showing treatment with empasiprubart for MMN reduced the risk of IVIg retreatment by 91% and demonstrated significant improvement in grip strength in both hands as compared to placebo. Data from a Patient Global Impression of Change scale show 94.4% of patients said they improved on empasiprubart from the start of the study, compared to 11.1% of placebo patients. As part of its commitment to the MMN community, argenx initiated the iMMersioN longitudinal study of approximately 150 patients to collect data on the impact of disease and burden of current treatment options on clinical outcomes and quality of life measures. A Phase 3 study of empasiprubart in MMN will start by the end of 2024.