InflaRx N.V. · NASDAQ:IFRX
InflaRx — Technical Presentation
14 slides from InflaRx's technical presentation
Slide 1: Long-Term Results from a Phase 2a Clinical Study with IFX-1 in Severe Hidradenitis Suppurativa
LONG-TERM RESULTS FROM A PHASE 2A CLINICAL STUDY WITH IFX-1 IN SEVERE HIDRADENITIS SUPPURATIVA Evangelos J. Giamarellos-Bourboulis1, Maria Argyropoulou1, Theodora Kanni1, Jens Henneberg2, Othmar Zenker2 14th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical Sch
Slide 2: Disclosure of Interests
DISCLOSURE OF INTERESTS • Evangelos Giamarellos-Bourboulis has received honoraria (paid to the University of Athens) from AbbVie, Biotest, Brahms GmbH, and The Medicines Company; has received compensation as a consultant for Astellas Greece, InflaRx GmbH, Germany and for XBiotech (paid to the Univer
Slide 3: Background: C5a Is Increased in HS
BACKGROUND: C5a IS INCREASED IN HS (Kanni T, et al. Br J Dermatol 2018; 179: 413-419) p: 0.006
Slide 4: IFX-1: Humanized Monoclonal IgG4κ Antibody Binding Soluble C5a
IFX-1: humanized monoclonal IgG4κ antibody specifically binding to the soluble human complement split product C5a Screening OPEN-LABEL FOLLOW-UP 800mg IFX-1 Weeks 0-8 Weeks 9-12 2 wks Days 1, 4, 8, 15, 22, 29, 36, 43, 50 Days 78, 106, 134 DLQI DLQI DLQI DLQI US US US C5a C5a C5a C5a C11b C11b C11b C
Slide 5: HiSCR Responders
HiSCR REPONDERS Open-label treatment Follow-up period *p<0.05 compared to day 22 **p: 0.089 compared to day 50 Giamarellos-Bourboulis EJ, et al. JAAD submitted
Slide 6: Aim of the Study
AIM OF THE STUDY To assess the long-term clinical efficacy of IFX-1 after cessation of the treatment.
Slide 7: Methodology
METHODOLOGY • Retrospective chart review until December 2017 • Recording of regular follow-up visits/consultations Clinical benefit assessment Flare-up • Total AN count Exacerbation of HS requiring oral or • Total draining fistulas intravenous antibiotic therapy. • Flare-ups (time) • HiSCR Treatment
Slide 8: Total Follow-Up Visits: 35 Visits, 10 Patients
TOTAL 35 FOLLOW-UP VISITS: 10 PATIENTS Number of Days since Median Number of visits start of IFX-1 (days) patients 9 139-198 175 7 11 234-296 253 8 11 302-391 369 9 4 408-488 421 5
Slide 9: HiSCR Responders
HiSCR REPONDERS End of trial folow-up End of open-label treatment Long-term follow-up *median period (n of patients); **pNS compared to day 134
Slide 10: Total AN Count
TOTAL AN COUNT Long-term follow-up p: 0.024** p: 0.010** p: 0.008** p: 0.018** p: 0.655** p: 0.026** *median period (n of patients) **compared to day 0 by Wilcoxon rank sum test
Slide 11: Total Fistula Count
TOTAL FISTULA COUNT Long-term follow-up p: 0.102** p: 0.175** p: 0.197** p: 0.024** p: 0.017** p: 0.593** *median period (n of patients) **compared to day 0 by Wilcoxon rank sum test
Slide 12: HS Flare-Ups Over Trial Periods
HS FLARE-UPS OVER TRIAL PERIODS 2.60 1.26/patient p: 0.0007* 0.20 0.42/patient 0.20 0.42/patient p: 0.0007* *by the Fisher exact test
Slide 13: Sustainability of Response: Time to First Flare-Up
SUSTAINABILITY OF RESPONSE: TIME TO FIRST FLARE-UP 50%: 203 days
Slide 14: Conclusions
CONCLUSIONS Following 8 weeks of treatment with IFX-1 for severe HS • HiSCR response is sustained until days 234-296 • All patients experience flare-ups at a rate greater than the first 134 days • Allthough off medication, 50% of patients have no flare up to day 203 • Data support the further develo