InflaRx N.V. · NASDAQ:IFRX
InflaRx — SVB Leerink Global Healthcare Conference 2020
17 slides from InflaRx's conference presentation, Feb 26, 2020
Slide 1: Controlling Inflammation
CONTROLLING INFLAMMATION SVB Leerink Global Healthcare Conference 2020
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by InflaRx N.V. (“InflaRx”), a US-Nasdaq publicly listed Dutch company having its principle place of business in Germany. This presentation is made for informational purposes only and does not constitute an offer to sell or a solici
Slide 3: Investment Highlights
Investment Highlights LEADING PROPRIETARY ANTI-C5A TECHNOLOGY • Complete and selective blockade of the biological activity of C5a in vitro and in vivo • Strong patent coverage on anti-C5a technology until end of 2030 / 2035 with extension ESTABLISHED CLINICAL EFFICACY FOR LEAD DRUG IFX-1 • Proven an
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities We have multiple ongoing Phase II studies with potential to expand into further indications PROPOSED INDICATIONS PREVALENCE PRE-CLINICAL PHASE I PHASE II PHASE III UPDATE IFX-1 Hidradenitis • Up to 200,000 • Phase IIb completed C5a Inhibitor Suppurativa (HS) pati
Slide 5: The Terminal Complement Pathway
The Terminal Complement Pathway C5 C5 concentration in blood: ~75 µg/ml (~400 nM) C5a C5b C5a concentration in blood: other ligands: 10 ~ 30 ng/ml (~1-2.5 nM) C3a, ASP, C4a etc Membrane Attack Complex (MAC) strong amplifier triggers lysis of pathogens of inflammation C5b-9 = MAC C5L2 has a different
Slide 6: IFX-1 in HS: SHINE Study Details
IFX-1 in HS: SHINE Study Details Main Period: n = 177 treated Open Label Extension Period (OLE): n = 156 Placebo Week 16 HiSCR Responders: IFX-1 minimal dose (400 mg q4w) (800 mg q4w) IFX-1 low dose IFX-1 low dose (800 mg q4w) Week 16 HiSCR Non-Responders: IFX-1 medium dose (800 mg q2w) (800 mg q2w)
Slide 7: SHINE Study: Primary Outcome HiSCR at Week 16 versus AN Count Reduction
SHINE Study: Primary Outcome HiSCR at Week 16 versus AN Count Reduction HiSCR response rate (%) week 16* AN count score change (mean %) week 16* n = approx. 35/ group 0 100 -10 90 80 -20 70 -30 -26,5 60 -40 -32,7 51,5 50 47,1 45,5 -50 -44,9 40,0 38,7 -47,7 40 -60 -54,6 30 -70 20 -80 10 -90 0 -100 Sp
Slide 8: SHINE Study: Outcome on Draining Fistula and IHS-4 Score Reduction – Week 16
SHINE Study: Outcome on Draining Fistula and IHS-4 Score Reduction – Week 16 Draining fistula change (mean %)* IHS-4 score change (mean %)** 0 0 -10 -10 -20 -14,5 -15 -20 -18 -19,8 -30 -30 -24,6 -28 -40 -40 -38,4 -41,1 -50 -50 -51,5 -60 -60 -70 -63,2 -70 -80 p= 0.0359 -80 p= 0.0202 Spalte4 Spalte4 T
Slide 9: Comparison of HiSCR for Week 16 Responder versus Non-responder Groups (OLE) Over Time
Comparison of HiSCR for Week 16 Responder versus Non-responder Groups (OLE) Over Time HiSCR response rate (%) per visit* (OLE) – with 95% CI All OLE patients 100 90 80 Responders 56,3 70 60 (n = 72) 50 Non-responders 40 (n = 84) 30 20 10 0 week 16 week 20 week 24 week 28 week 32 week 36 week 40 HiSC
Slide 10: Inflammatory Lesion Reductions in All OLE Patients at End of Treatment
Inflammatory Lesion Reductions in All OLE Patients at End of Treatment (Week 40) Compared to Placebo Group Performance in Main Period (Week 16) Relative reduction (% mean) of counts / scores compared to respective baseline (Day 1)* of all OLE patients at week 40 (n=116) of placebo patients at week 1
Slide 11: SHINE Study and Next Steps in HS Development
SHINE Study and Next Steps in HS Development OUR CONCLUSIONS NEXT STEPS • HiSCR is burdened by high variability (driven by AN • Request End-of-Phase II FDA Meeting in count variability) and by a lack of capturing reduction Q1 2020 of draining fistula • Discuss with FDA the path forward for • Evidenc
Slide 12: Pyoderma Gangraenosum (PG)
Pyoderma Gangraenosum (PG) AN AUTOIMMUNE CONDITION WITH HIGH UNMET NEED CLINICAL FEATURES • PG is a rare ulcerative skin disorder that can lead to chronic painful and difficult-to-treat wounds / ulcers occurring predominantly in people in their 40s and 50s • Many PG patients also suffer from other a
Slide 13: Overview of IFX-1 Phase IIa Study in PG - Study Design
Overview of IFX-1 Phase IIa Study in PG - Study Design STUDY OBJECTIVE STUDY DESIGN TREATMENTS • Assessing safety and efficacy of IFX-1 in PG • Open label • Trial started with 1 dose group: amendment • Rationale: • Multi-center in US and approved to introduce a PG is associated with a neutrophilic l
Slide 14: Pyoderma Gangraenosum (PG) Study Update
Pyoderma Gangraenosum (PG) An AUTOIMMUNE CONDITION with high unmet need STUDY UPDATE C5A LEVELS AT BASELINE • 5 patients have been treated C 5 a le v e l in P G p a tie n ts • 2 out of the first 5 patients showed complete closure of the target ulcer with one patient in full disease remission and 80
Slide 15: Pyoderma Gangraenosum: Two Patients Show Complete Wound Closure
Pyoderma Gangreaosum (PG) Two patients show complete wound closure with IFX-1 treatment PATIENT EXAMPLE 1 • Female patient with extensive genital PG disease and target ulcer on lower extremity • Various failed treatment attempts including high dose corticosteroids, etc. • Significantly elevated base
Slide 16: Our Strategy
Our Strategy GOALS AND STRATEGY • Advance our lead program IFX-1 for HS towards Phase III / approval based on regulatory guidance • Explore application of IFX-1 for AAV, PG and within the oncology field in Phase II clinical development • Extend pipeline with initiation of clinical development of IFX
Slide 17: InflaRx N.V. Investor Relations
INFLARX N.V. INVESTOR RELATIONS INFLARX N.V. Winzerlaer Str. 2 Jordan Zwick 07745 Jena, Germany Global Head of Business Development & Corporate Strategy Email: [email protected] Email: [email protected] Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com
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