empasiprubart (ARGX-117) / argenx, Broteio - LARVOL DELTA

argenx to Highlight Key Data and Breadth of Immunology Innovation at 2025 AANEM Annual Meeting and MGFA Scientific Session (GlobeNewswire) - "Results from the Phase 3 ADAPT SERON study evaluating VYVGART for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody negative (AChR-Ab seronegative) show clinically meaningful improvements in disease activity across all three subtypes (triple negative, MuSK, and LRP4-Ab seropositive); ADAPT Jr interim results assess age-appropriate dosing, safety, and clinical effect of VYVGART in juvenile gMG...VYVGART Hytrulo CIDP data highlight functional improvement, long-term safety, and real-world characteristics of patients, underscoring the need for early treatment with effective and well-tolerated therapies; Two Phase 3 study designs for empasiprubart in CIDP – EMVIGORATE and EMNERGIZE – demonstrate argenx’s commitment to advancing innovative therapies and transforming outcomes for patients."

Clinical data • Clinical protocol • Immunology • Myasthenia Gravis

emnergize: A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

empacific: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=3 | Active, not recruiting | Sponsor: argenx | Recruiting ➔ Active, not recruiting | N=42 ➔ 3 | Trial completion date: Jan 2028 ➔ Nov 2026 | Trial primary completion date: Jul 2025 ➔ Nov 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

ARGX-117-2401: A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP (clinicaltrials.gov) - P3 | N=218 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting | Trial completion date: May 2030 ➔ Sep 2030 | Initiation date: May 2025 ➔ Aug 2025 | Trial primary completion date: May 2027 ➔ Sep 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Pain

Empasiprubart in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function: A Phase 2 Trial in Progress (WTC 2025) - P2 | "VARVARA is a phase 2, multicenter, randomized, double-blinded, placebo-controlled trial to examine the efficacy, safety, and tolerability of empasiprubart in improving allograft function in recipients of a deceased donor renal allograft at risk for DGF."

P2 data • Cardiovascular • Inflammation • Nephrology • Reperfusion Injury

Randomized phase I trial outcomes show safe and sustainable inhibition of classical and lectin complement pathways by empasiprubart. (PubMed, Nat Commun) - P1 | "Single and multiple ascending doses of empasiprubart are generally safe and well tolerated. Overall, our results reveal in atomic detail the mechanism of empasiprubart and demonstrate that it is a first-in-class anti-C2 therapeutic antibody for use in complement-mediated diseases."

Clinical • Journal • P1 data

emnergize: A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP (clinicaltrials.gov) - P3 | N=160 | Not yet recruiting | Sponsor: argenx

New P3 trial • Pain

VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (clinicaltrials.gov) - P2 | N=103 | Active, not recruiting | Sponsor: argenx | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Jul 2026 | Trial primary completion date: Apr 2026 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date • Transplantation

Safety, tolerability, and efficacy of empasiprubart in adults with dermatomyositis (EMPACIFIC): A phase 2, randomized, double-blind, placebo-controlled, multicenter study (EULAR 2025) - P2 | "This phase 2 study will evaluate the safety, tolerability, and efficacy of empasiprubart in adults with DM."

Clinical • P2 data • Cardiovascular • Complement-mediated Rare Disorders • Dermatology • Dermatomyositis • Immunology • Myositis • Pain

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: argenx | Trial completion date: Sep 2026 ➔ Sep 2029 | Trial primary completion date: Sep 2026 ➔ Sep 2029

Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Pain

emvigorate: A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP (clinicaltrials.gov) - P3 | N=218 | Not yet recruiting | Sponsor: argenx

New P3 trial • Pain

Empassion: A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Complement-mediated Rare Disorders • Pain

Empassion: A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: argenx

New P3 trial • Complement-mediated Rare Disorders • Pain

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: argenx | Enrolling by invitation ➔ Active, not recruiting | Trial primary completion date: Nov 2025 ➔ Sep 2026

Enrollment closed • Trial primary completion date • Complement-mediated Rare Disorders • Pain

ARDA: A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=54 | Completed | Sponsor: argenx | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2024 | Trial primary completion date: Oct 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Pain

empacific: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults with Dermatomyositis (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatomyositis • Immunology • Myositis

argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update (GlobeNewswire) - "Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $478 million in second quarter of 2024...Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024...Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024."

New P1/2 trial • New P3 trial • Sales • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology • Myasthenia Gravis

empacific: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: argenx | N=80 ➔ 42

Enrollment change • Dermatomyositis • Immunology • Myositis

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=48 | Enrolling by invitation | Sponsor: argenx | Recruiting ➔ Enrolling by invitation

Enrollment status • Complement-mediated Rare Disorders • Pain

Empasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Initial Safety and Efficacy data of the Phase 2 ARDA Study (EAN 2024) - P2 | "Early efficacy and safety signals in cohort 1 from the ongoing ARDA study support proof of concept of empasiprubart in MMN."

Clinical • P2 data • Complement-mediated Rare Disorders • Pain

argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ during its Upcoming R&D Day on July 16, 2024 (GlobeNewswire) - "argenx SE...today announced that it will host an R&D day on Tuesday, July 16, 2024 at 8:30am ET in New York City to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ and provide updates from across its current and future clinical pipeline....The R&D Day agenda will include the following topics...Topline Phase 2 RHO data in Sjogren’s disease; Preview of Phase 2/3 ALKIVIA study in immune-mediated myopathies; Expansion of MG opportunity through label-enabling studies, including seronegative MG...Next pipeline-in-a-product opportunity with empasiprubart; Phase 2 ARDA data in multifocal motor neuropathy (MMN); Preview of Phase 2 studies in delayed graft function and dermatomyositis; Introduction of fourth indication..."

New indication • P2 data • P2/3 data • Dermatomyositis • Immunology • Myasthenia Gravis • Myositis • Sjogren's Syndrome

ARGX-117-2301: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: argenx | Initiation date: May 2024 ➔ Sep 2024

Trial initiation date • Dermatomyositis • Immunology • Myositis

VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (clinicaltrials.gov) - P2 | N=102 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation

A Study of Empasiprubart's Effect on the Body, Levels in the Blood, Effectiveness, and Safety in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: argenx

New P2 trial • Dermatomyositis • Immunology • Myositis

ARDA: A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=54 | Active, not recruiting | Sponsor: argenx | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Oct 2024 | Trial primary completion date: Feb 2024 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Pain