Inflarx N.v. · NASDAQ:IFRX
Inflarx — Technical Presentation (January 2024)
27 slides from Inflarx's technical presentation, Jan 4, 2024
Slide 1: INF904: Topline Results from Phase I MAD Study
INF904: TOPLINE RESULTS FROM PHASE I MAD STUDY JANUARY 4, 2024
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by InflaRx N.V. (“InflaRx” or the “Company”). This presentation is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. This presentation may not be relied up
Slide 3: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER Information and Sources Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and InflaRx’s own internal estimates and research. While InflaRx believes these third-p
Slide 4: Speakers
Speakers Speaker Q&A PROF. NIELS RIEDEMANN, M.D., PH.D. PROF. RENFENG GUO, M.D. Chief Executive Officer, Founder, InflaRx Chief Scientific Officer, Founder, InflaRx CAMILLA CHONG, M.D. THOMAS TAAPKEN, PH.D. Chief Medical Officer, InflaRx Chief Financial Officer, InflaRx Page 4
Slide 5: Agenda
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 5
Slide 6: Agenda: Background and Pre-clinical Work
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 6
Slide 7: The Complement System and C5a Activation
The Complement System and C5a Activation Extrinsic “Pathway” Complement Pathways Enzymatic C5 Cleavage Classical Lectin Alternative Thrombin, Trypsin, Elastase, etc. Antibody binding Mannose binding Foreign surfaces C3 activation C5-convertases C5 C5 Scissile bonds Arg751/ C5a = potent Leu752 anaphy
Slide 8: C5aR is a Validated Drug Target for Inflammation
C5aR is a Validated Drug Target for Inflammation C5aR: a promising drug target Role of C5aR in pre-clinical and clinical R&D • C5aR, a G-protein-coupled receptor highly expressed on granulocytes and in epithelial cell, mediates the Immuno-Dermatology major pathophysiological effects of C5a. • Blocka
Slide 9: Improvement of C5aR Inhibition
Improvement of C5aR Inhibition Properties of a best-in-class C5aR antagonist • Improved PK properties with higher plasma trough level (>> 36 ng/mL) to achieve: • Improved blocking activity in vivo in humans (>> 50% blocking at 10 nM C5a) = significantly stronger inhibition of neutrophil hypothetical
Slide 10: INF904: Pre-clinical Summary
INF904: Pre-clinical Summary C5a INF904 facts • INF904 binds to a well-defined allosteric site in C5aR. Trp213 (human, primate, hamster) • INF904 has a novel molecular structure. • US patent was issued in October 2021; national phases for other select countries (PCT). INF904 binds to allosteric bind
Slide 11: INF904 Phase I Study Designs for SAD and MAD
INF904 Phase I Study Designs for SAD and MAD Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) 3mg Safety evaluation SAD (N=8, in 6:2 ratio) 10mg Safety evaluation SAD (N=8, in 6:2 ratio) 30mg QD Safety evaluation MAD 30mg Safety evaluation N=8 (in 6:2 ratio) SAD (N=8, in 6:2 ratio) 30mg BID
Slide 12: Agenda: Safety Outcome
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 12
Slide 13: Safety Results from MAD (and SAD) Part – Primary Objectives
INF904 Phase I Study: Safety Results from MAD (and SAD) Part – Primary Objectives SAD PART MAD PART • INF904 was found to be well tolerated and resulted in • INF904 was found to be well tolerated and resulted no signals of safety concern in single ascending doses in no signals of safety concern in m
Slide 14: Agenda: PK Outcome
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 14
Slide 15: PK Results from the Multiple Ascending Dose (MAD)
INF904 Phase I Study: PK Results from the Multiple Ascending Dose (MAD) AUC0-12hr (ng x hr/mL) ± Dose (Regimen) Day Cmax (ng/mL) ±SD SD 1 233 ± 79 1,615 ± 427 30 mg QD 14 284 ± 60 2,609 ± 792 1 236 ± 97 1,742 ± 648 30 mg BID 14 356 ± 84 3,331 ± 821 1 653 ± 217 4,815 ± 1,993 90 mg BID 14 1,028 ± 431
Slide 16: Agenda: PD Outcome
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 16
Slide 17: Phase I: Whole Blood PD Analysis
INF904 – Phase I: Whole Blood PD Analysis Multiple Ascending Dose (MAD) Part INF904: 30 mg QD INF904: 30 mg BID INF904: 90 mg BID rh C 5 a -C D 1 1 b R e s p o n s e , 3 0 m g q .d ., 1 4 d o s e s r h C 5 a - C D 1 1 b R e s p o n s e , 3 0 m g b .i. d . , 2 7 d o s e s r h C 5 a - C D 1 1 b R e s
Slide 18: Agenda: Summary
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 18
Slide 19: Summary
Summary Topline Results from INF904 Phase I MAD Study KEY OUTCOMES INF904 was found to be well tolerated and with no signals of safety concern in multiple ascending doses ranging from 30mg QD – 90 mg BID. INF904 demonstrated a favorable PK profile with potential to achieve therapeutic exposures (AUC
Slide 20: INF904: Next Steps
INF904: Next Steps HIGHLIGHTS Further drug development steps: ▪ Introducing developed commercially viable formulation for Phase II clinical program ▪ Complete long-term chronic toxicology studies ▪ Planning for Phase II clinical studies to be initiated towards end of 2024 Page 20
Slide 21: www.inflarx.com
www.inflarx.com INFLARX N.V. Winzerlaer Str. 2 07745 Jena, Germany Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181
Slide 22: Appendix
Appendix PRE-CLINICAL DATA (PREVIOUSLY REPORTED) SAD DATA (PREVIOUSLY REPORTED) Page 22
Slide 23: Pre-clinical In Vivo Efficacy Comparison of INF904 to Avacopan
INF904: Potential Best-in-Class C5aR Inhibitor PRE-CLINICAL IN VIVO EFFICACY COMPARISON OF INF904 to AVACOPAN* Inhibition of in vivo neutrophil activation by Experiment: Challenge of rodents with C5a leads to neutrophil INF904 compared to Avacopan-like molecule* activation and consequent adherence (
Slide 24: INF904 Phase I Study: PK Results from SAD Part
INF904 Phase I Study: PK Results from SAD Part 1,400 Parameter Unit Dose INF904 Avacopan* Avacopan INF904 30mg 3mg INF904 3mg INF904 10mg AUCinf h.ng/ml 3 mg 285 25 1,200 INF904 10mg INF904 30mg 10 mg 1264 130 INF904 30mg INF904 60mg INF904 60mg INF904 30 mg 5956 628 1,000 INF904 120mg 120mg INF904
Slide 25: INF904 Phase I Study: Safety Results from SAD Part
INF904 Phase I Study: Safety Results from SAD Part HIGHLIGHTS • INF904 was well tolerated in treated healthy volunteers and resulted in no safety signals of concern in single ascending doses ranging from 3mg to 240mg. • Overall percentage of adverse events (AEs) in placebo group was higher than in a
Slide 26: INF904 Phase I Study: PD Results from SAD Part
INF904 Phase I Study: PD Results from SAD Part C5a-mediated CD11b upregulation on neutrophils ex vivo at 24h post dosing rh C 5 a -C D 1 1 b R e s p o n s e , T = 2 4 h • INF904: In response to 12.64 nM of C5a, ≥ 90% blocking activity was observed in the 120 PD analysis in the dose range of 30-240 m
Slide 27: Summary
Summary Topline Results from INF904 Phase I SAD Study KEY OUTCOMES INF904 was well tolerated in treated healthy volunteers and resulted in no safety signals of concern in single ascending doses ranging from 3mg to 240mg. INF904 demonstrated a favorable PK profile: Tmax 6 hours, dose proportional exp