argenx Progresses Efgartigimod SC for Myositis Treatment

Clinical Advancement of Efgartigimod SC in Myositis

In a significant step for autoimmune disease treatment, argenx SE (Euronext & Nasdaq: ARGX) is advancing the clinical development of Efgartigimod subcutaneous (SC). This innovative therapy targets idiopathic inflammatory myopathies (IIM or myositis), a group of rare diseases that can lead to debilitating muscle weakness. With a commitment to improving patients' lives, argenx has decided to proceed with its Phase 2/3 ALKIVIA study following the positive topline data analysis.

Promising Phase 2 Results

The recent Phase 2 results have established a strong proof-of-concept for Efgartigimod SC, demonstrating a meaningful treatment effect at Week 24. Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx, expressed optimism regarding the potential of this therapy, particularly for myositis patients who currently have limited options. Efgartigimod SC aims to fill a gap where traditional treatments, such as steroids and broad immunosuppressant therapies, may fall short.

Subtypes Under Evaluation

The ALKIVIA study encompasses all three myositis subtypes: immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). Efgartigimod SC seeks to address the diverse needs of patients across these subtypes, which collectively impact muscle and organ functionality.

Study Design of ALKIVIA

Designed as a double-blind, placebo-controlled, randomized study, the ALKIVIA trial plans to enroll up to 240 patients, with ongoing analyses of its two phases. The study's primary endpoint is the mean total improvement score (TIS) at treatment completion, which is set for 24 weeks in Phase 2 and extends to 52 weeks in Phase 3. The safety profile observed in Phase 2 is consistent with previous trials, bolstering confidence in the therapy's viability.

Understanding Myositis

Idiopathic inflammatory myopathies represent a challenging and often misunderstood group of autoimmune conditions. These can vary in severity and may affect various organs beyond muscles, like the skin and lungs. The complexity of myositis often necessitates a specific and targeted approach, especially as the clinical community continues to uncover new subtypes through improved diagnostic techniques.

About Efgartigimod SC

Efgartigimod SC, recognized as the first approved FcRn blocker globally, holds the potential for broad applications across numerous autoimmune disorders. By targeting pathogenic immunoglobulin G antibodies, this innovative treatment approach aims to enhance patient outcomes significantly in a spectrum of diseases where IgGs mediate pathology.

Argenx's Commitment to Innovation

As a leader in immunology, argenx is dedicated to transforming the future of autoimmune disease treatment. The company collaborates with top academic institutions through its Immunology Innovation Program to create groundbreaking antibody-based therapies. Given its focused research and development strategy, argenx aims to revolutionize treatment paradigms for patients worldwide, continuing its commitment to improve their health and quality of life.

Frequently Asked Questions

What is Efgartigimod SC?

Efgartigimod SC is a treatment developed by argenx, aimed at reducing pathogenic immunoglobulin G antibodies in patients with autoimmune diseases.

What are idiopathic inflammatory myopathies?

Idiopathic inflammatory myopathies refer to a rare class of autoimmune diseases characterized by muscle weakness, which can affect other organs as well.

What makes the ALKIVIA study unique?

The ALKIVIA study is a seamless Phase 2/3 trial that evaluates Efgartigimod SC's efficacy across multiple myositis subtypes, enhancing its relevance in clinical research.

Why is Efgartigimod SC important for myositis patients?

This therapy represents a potential breakthrough for myositis patients who currently lack effective targeted treatment options, aiming to improve their quality of life.

Who can I contact for more information about argenx?

For inquiries, you can reach out to Ben Petok for media questions and Alexandra Roy or Lynn Elton for investor inquiries.

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