Breakthroughs in Immunology: argenx Presents Key Data from AANEM

Impactful Data Presented by argenx at Annual Meetings

Long-term and real-world studies show impressive results from VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alpha and hyaluronidase-qvfc), highlighting the speed of onset, depth of response, and durability of treatment outcomes.

The findings indicate a favorable safety profile with over 8,000 patient years of clinical safety data; there's no need for vaccinations and no adverse effect on serum albumin levels.

Data revealed that more than half of generalized Myasthenia Gravis (gMG) patients showed significant and maintained reductions in steroid use after initiating VYVGART treatment.

argenx is actively expanding its presence in neurology, particularly through its innovative pipeline programs, including empasiprubart and ARGX-119 for conditions such as multifocal motor neuropathy (MMN) and amyotrophic lateral sclerosis (ALS).

Date: October 15, 2024

Location: Amsterdam, the Netherlands

At the recently held 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Sessions, argenx SE (Euronext & Nasdaq: ARGX), a leader in immunology dedicated to enhancing the lives of individuals with severe autoimmune disorders, showcased compelling clinical and real-world outcomes from its diverse immunology pipeline.

“The data we present today at AANEM empowers our mission,” stated Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “VYVGART not only continues to demonstrate its benefits in terms of safety and effectiveness but also reaffirms its role as a vital therapeutic option for patients by significantly reducing steroid dependence and rapidly alleviating CIDP symptoms. Our dedication extends to advancing innovative therapies through our expanding pipeline.”

VYVGART and Its Depth of Impact on gMG and CIDP

The presentation at AANEM underlined the revolutionary impact of VYVGART - the first-in-class neonatal Fc receptor (FcRn) blocker designed for individuals suffering from generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). With consistent data showing rapid, deep, and sustainable responses, VYVGART is setting new standards of care in gMG, allowing an impressive proportion of patients to experience minimal symptom expression (MSE) with a reassuring safety profile backed by extensive data.

Real-world evidence suggests that over 50 percent of patients can decrease steroid intake by more than 5 mg/day after starting on VYVGART. Moreover, participants in the ADHERE trial exhibited a notably reduced risk of relapse and enhanced motor function and strength when treated with VYVGART Hytrulo compared to placebo therapies.

Key Highlights from AANEM and MGFA Presentations

• Early Intervention and Steroid Minimization: Real-world data confirmed that a significant number of gMG patients, specifically 55%, reduced corticosteroid use by at least 5 mg/day one year after starting VYVGART, with 42% achieving steroid doses at or below 5 mg/day.
• Inclusive Studies for Broader Patient Demographics: Two Phase 3 clinical studies are ongoing to investigate VYVGART in seronegative (ADAPT-SERON) and ocular MG (ADAPT-OCULUS) populations.
• Sustained Benefits in CIDP: VYVGART Hytrulo showed sustained improvements in muscle strength and function in CIDP patients, with positive results maintained throughout clinical evaluations.
• Safety Profile Assurance: VYVGART demonstrated a consistent and reassuring safety profile, with no increase in adverse events noted with increased exposure, nor requirements for lab or immunoglobulin monitoring.

Advancing Toward Innovative Treatments

Additionally, argenx presented two promising candidates in its pipeline: empasiprubart (anti-C2 inhibitor) and ARGX-119 (MuSK agonist) targeting various neuromuscular disorders. The Phase 2 ARDA trial results for empasiprubart showed a staggering 91% reduction in the need for intravenous immunoglobulin retreatment in MMN patients.

Moreover, ongoing studies such as the iMMersioN longitudinal study seeks to examine the effects of MMN on patient quality of life, while a Phase 3 trial for empasiprubart is anticipated to commence soon.

Upcoming Presentations at MGFA and AANEM

• Posters discussing these findings will be showcased, ensuring visibility for argenx’s research and contributions in these influential medical spaces.

As argenx continues to focus on its core mission of tackling severe autoimmune disorders through cutting-edge research and innovative therapies, VYVGART stands out as a pivotal treatment changing the landscape of care for patients. With ongoing studies and advancements in its pipeline, argenx positions itself not only as a leader in immunology but as a lifeline for those affected by debilitating diseases.

Frequently Asked Questions

What is VYVGART used for?

VYVGART is primarily used to treat generalized myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies.

What are the main benefits of VYVGART?

VYVGART shows rapid, deep, and sustained responses with minimal side effects, along with a significant reduction in corticosteroid usage in many patients.

What is the safety profile of VYVGART?

Studies demonstrate that VYVGART has a consistent safety profile with no serious adverse events linked to its increased use, along with no additional laboratory monitorings required.

What other conditions are being explored with argenx pipelines?

Argx-119 and empasiprubart are in development for treating multifocal motor neuropathy, amyotrophic lateral sclerosis, and congenital myasthenic syndromes.

How can I contact argenx for more information?

For media inquiries, you can email Ben Petok at bpetok@argenx.com. For investor-related inquiries, contact Alexandra Roy at arooy@argenx.com.

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