Argenx Se · EURONEXT:ARGX
Argenx — Technical Presentation (March 2022)
15 slides from Argenx's technical presentation, Mar 22, 2022
Slide 1: Together We Discover: Topline Results: ADAPT-SC Bridging Study in gMG
Together We Discover Reaching Patients Through Immunology Innovation Topline Results: ADAPT-SC Bridging Study in gMG March 22, 2022 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation has been prepared by argenx SE (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or
Slide 3: Patient Experience: Living with gMG
GENERALIZED KIM Living with gMG MYASTHENIA GRAVIS gMG is characterized by debilitating muscle Patient weakness and fatigue. Symptoms can vary from patient to patient, day to day, or even throughout the same day... this unpredictability Experience contributes to emotional burden of disease have been
Slide 4: Multiple Formulations Aim to Offer Patients Optionality
Multiple Formulations Aim to Offer Patients Optionality 1000mg 10 mg/kg SC efgartigimod Intravenous infusion Single subcutaneous injection 4
Slide 5: Innovative Trial Designed to Accelerate Path Forward
Innovative Trial Designed to Accelerate Path Forward Leveraged correlation between pharmacodynamic and clinical effect as observed in ADAPT Met primary endpoint, demonstrating noninferior total IgG reduction at day 29 with subcutaneously administered efgartigimod compared to intravenous (IV) adminis
Slide 6: SC Bridging Strategy Leverages Correlation Between Pharmacodynamic and Clinical Effect
SC Bridging Strategy Leverages Correlation Between Pharmacodynamic and Clinical Effect Efgartigimod-treated patients • ADAPT established association of total IgG and MG-ADL from Phase 3 ADAPT following efgartigimod treatment • Phase 1 HV data showed SC efgartigimod has similar PD effect as VYVGART •
Slide 7: ADAPT-SC Bridging Study Design
ADAPT-SC Bridging Study Design 110 adult gMG patients Patients randomized 1:1 to receive MGFA Class II, III, IV 1000 mg SC efgartigimod or VYVGART Anti-AChR antibody positive All patients receive one (n=91) and negative (n=19) treatment cycle DESIGN MG-ADL score ≥5a (4 weekly single injections or 1-
Slide 8: Primary Endpoint Met: SC Efgartigimod Noninferior to IV
Primary Endpoint Met: SC Efgartigimod Noninferior to IV Primary endpoint of noninferiority met [p<0.0001] Mean total IgG reduction from baseline at day 29 IgG reduction (%) in all ADAPT-SC and ADAPT participants 66.4% 62.2% SC efgartigimod VYVGART ADAPT-SC AChR-Ab, acetylcholine receptor antibody; M
Slide 9: Consistent Clinical Efficacy Between SC and IV
Consistent Clinical Efficacy Between SC and IV MG-ADL RESPONDERS QMG RESPONDERS MINIMAL SYMPTOM EXPRESSION 69.1% 69.1% 65.5% 51.9% 37.0% 38.2% n=38/55 n=38/55 n=36/55 n=28/54 n=20/54 n=21/55 SC efgartigimod VYVGART SC efgartigimod VYVGART SC efgartigimod VYVGART SECONDARY SECONDARY EXPLORATORY MG-AD
Slide 10: Fast, Deep and Durable Responses
Fast, Deep and Durable Responses Total change from baseline in MG-ADL score over time Total change from baseline in QMG score over time across ADAPT and ADAPT-SC across ADAPT and ADAPT-SC Mean MG-ADL reduction Mean QMG reduction ADAPT-SC ADAPT-SC 10
Slide 11: Safety: Summary of Adverse Events
Safety: Summary of Adverse Events SC efgartigimod IV efgartigimod (n=55) (n=55) Number of patients with an Adverse Event (AE) n (%) 37 (67.3) 28 (50.9) Number of patients with an AE grade ≥3 n (%) 9 (16.4) 4 (7.3) Most frequent AEs n (%) Injection site reactions* 21 (38.2) 1 (1.8) Headache** 7 (12.7
Slide 12: Differentiated Treatment Options for gMG Patients
Differentiated Treatment Options for gMG Patients SC efgartigimod ADAPT-NXT single injection Continuous Dosing Future Delivery Vehicles and Formulations (e.g., pre-filled syringe, Elektrofi, autoinjector) Eri, living with gMG 12 12
Slide 13: SC Formulation Leveraged Across Indications
SC Formulation Leveraged Across Indications LEVERAGE FORMULATIONS ACROSS MULTIPLE INDICATIONS, THERAPEUTIC gMG ITP Pemphigus CIDP Myositis BP Membranous Lupus COVID-19- Sjogren’s FRANCHISES, AND Nephropathy Nephritis mediated Syndrome MOLECULES POTS IV for POC Key: NEURO HEME SKIN KIDNEY ENHANZETM S
Slide 14: Where critical patient need meets breakthrough science
Where critical patient need meets breakthrough science That is where we redefine immunology 14
Slide 15: Together We Discover
Together We Discover Reaching Patients Through Immunology Innovation 15