InflaRx N.V. · NASDAQ:IFRX
InflaRx — Technical Presentation (November 2019)
14 slides from InflaRx's technical presentation, November 2019
Slide 1: IFX-1 in Moderate to Severe Hidradenitis Suppurativa: SHINE Baseline Characteristics
IFX-1 IN MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA Baseline characteristics of a double-blinded, randomized phase 2b dose- finding study (SHINE) Evangelos J. Giamarellos-Bourboulis1, Jens Henneberg2, Isabell Otto2, Gregor B. E. Jemec3, Errol P. Prens4, Hessel H. van der Zee4, Christopher Sayed5, C
Slide 2: Conflicts of interest
Conflicts of interest 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 University
Slide 3: Background Information on IFX-1
Background Information on IFX-1 IFX-1 is a monoclonal antibody which specifically binds to the soluble human complement split product C5a. Nonclinical studies have demonstrated that IFX-1 binds to its target rapidly and is capable of a nearly complete blockade of C5a-induced biological effects w
Slide 4: Small-scale Phase IIa study
SMALL-SCALE PHASE IIa STUDY (Giamarellos-Bourboulis EJ, et al. 7th EHSF 2018) Open-label treatment Follow-up period • 12 patients • Refractory or not eligible for adalimumab • 800mg of IFX-1 • Once weekly • Nine doses in total • HiSCR *p<0.05 compared to day 22 **p: 0.089 compared to day 50
Slide 5: Aim of the study
Aim of the study Here we present the demographics and baseline characteristics of a phase IIb study with the objective to establish a dose response relationship A randomized, double-blind, placebo-controlled, multicenter Phase II study to determine efficacy and safety of IFX-1 in subjects with moder
Slide 6: SHINE Study Design
SHINE Study Design Prospective, randomized, 2-period, double-blind, placebo-controlled multicenter study, n = 175 Patients who develop a worsening of disease (for responders) or absence of improvement (for non-responders) on 2 consecutive visits during the OLE phase will be discontinued from the
Slide 7: SHINE Study Population
SHINE Study Population Key inclusion criteria Diagnosis of HS more than 1 year Moderate or severe HS Stable HS for at least 2 months before Screening Total abscess and inflammatory nodule (AN) count of ≥ 3 Key exclusion criteria More than 20 draining fistulas Prior treatment with ada
Slide 8: SHINE Study-Criteria for Evaluation
SHINE Study-Criteria for Evaluation Primary endpoint Percentage of subjects with a response on the basis of the HiSCR determined at Week 16 Secondary endpoints Modified Sartorius Score Number of draining fistula Dermatology Life Quality Index (DLQI) score from Day 1 by time point Patient
Slide 9: SHINE Study: Demographics
SHINE Study: Demographics Gender Male (44%) Female (56%) Race Black (9.5%) White (85%) Ethnicity Hispanic or Not hispanic or Latino Latino (0.04%) (96%) Age (mean +/- SD) 37.1 +/- 11.45 years
Slide 10: SHINE Study: Baseline characteristics
SHINE Study: Baseline characteristics Hurley Stage II 59.2% Mean weight +/- SD 92.2 +/-18.3 kg Hurley Stage III 40.8% Tobacco use 64.8% Median AN count 9 (3–58) Alcohol use 34.1% Median abscess count 1 (0 – 21) Median duration of HS 8 years (1 to 39) Median draining fistula 2 (0 – 20) Family history
Slide 11: Comparisons vs PIONEER studies (1)
Comparisons VS PIONEER studies (1) Baseline characteristics SHINE PIONEER I PIONEER II Mean weight +/- SD 92.2 +/-18.3 kg 98.2 +/- 25.0 92.9 +/- 24.0 Tobacco use 64.8% 65.8% 56.4% Alcohol use 34.1% 53.4% 58.9% Median duration of HS 8 years (1 to 39) 9 9 Family history of HS 22.9% 23.1% 25.2% Prior H
Slide 12: Comparisons vs PIONEER studies (2)
Comparisons VS PIONEER studies (2) Baseline characteristics SHINE PIONEER I PIONEER II Hurley Stage II 59.2% 52.4% 53.7% Hurley Stage III 40.8% 47.6% 46.3% Median AN count 9 (3-58) 14.3 (3-141) 8 (3-66) Median abscess count 1 (0-21) 2 (0-24) 1 (0-16) Median draining fistula 2 (0-20) 2(0-20) 1 (0-20)
Slide 13: SHINE Study – the right study population was chosen
SHINE Study – the right study population was chosen Demographics and baseline characteristics of the SHINE study match: Data previously reported in phase II and III programs for the development of adalimumab in HS1 Globally similar patient population Main differences: gender distribution (SHIN
Slide 14: Conclusions
Conclusions The SHINE study is being performed to establish a dose response relationship for IFX-1 in patients with moderate to severe HS and to confirm the mode of action. The patient demographic data and baseline characteristics of patients recruited into the SHINE trial are comparable to that