Slide 1: 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: Information and Sources
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 Page 4 Prof. Renfeng Guo, M.D. Chief Scientific Officer, Founder, InflaRx Prof. Niels Riedemann, M.D., Ph.D. Chief Executive Officer, Founder, InflaRx Thomas Taapken, Ph.D. Chief Financial Officer, InflaRx Camilla Chong, M.D. Chief Medical Officer, InflaRx Speaker Q&A
Slide 5: Agenda
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part Page 5 AGENDA safety outcome pk outcome pd outcome study design background and pre-clinical work summary
Slide 6: Agenda: Background and Pre-clinical Work
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part Page 6 AGENDA safety outcome pk outcome pd outcome study design background and pre-clinical work summary
Slide 7: The Complement System and C5a Activation
The Complement System and C5a Activation Page 7 Classical Lectin Alternative Complement Pathways Membrane Attack Complex (MAC)triggers lysis of pathogens Antibody binding Mannose binding Foreign surfaces C3 activation C5b-9 = MAC C5-convertases C5b Terminalcomplementactivation C5 Arg751/ Leu752 The
Slide 8: C5aR: a promising drug target
Page 8 C5aR, a G-protein-coupled receptor highly expressed on granulocytes and in epithelial cell, mediates the major pathophysiological effects of C5a. Blockade of C5aR showed strong anti-inflammatory effects in numerous pre-clinical disease models in both acute and chronic settings and in clinical
Slide 9: Properties of a best-in-class C5aR antagonist
Page 9 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 activation at C5a levels known to be present in diseases. Improved drug strength to al
Slide 10: Pre-clinical Summary
INF904: Pre-clinical Summary INF904 binds to a well-defined allosteric site in C5aR. INF904 has a novel molecular structure. US patent was issued in October 2021; national phases for other select countries (PCT). INF904 facts Page 10 Pre-clinical findings No obvious toxicity findings even in the hig
Slide 11: INF904 Phase I Study Designs for SAD and MAD
Page 11 INF904 Phase I Study Designs for SAD and MAD 3mg SAD (N=8, in 6:2 ratio) Safety evaluation Safety evaluation Safety evaluation Safety evaluation Safety evaluation 30mg QD MAD N=8 (in 6:2 ratio) Safety evaluation Safety evaluation Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) Foot
Slide 12: Agenda: Safety Outcome
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part Page 12 AGENDA safety outcome pk outcome pd outcome study design background and pre-clinical work summary
Slide 13: Safety Results from MAD (and SAD) Part
Page 13 INF904 was found to be well tolerated and resulted in no signals of safety concern in single ascending doses ranging from 3 mg to 240 mg. Overall percentage of Adverse Events (AEs) in placebo group (85.7%) was higher than in active treated subjects (58.3%). AE severity: Mild: 78; Moderate: 9
Slide 14: Agenda: PK Outcome
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part Page 14 AGENDA safety outcome pk outcome pd outcome study design background and pre-clinical work summary
Slide 15: PK Results from the Multiple Ascending Dose
INF904 Phase I Study: PK Results from the Multiple Ascending Dose (MAD) Page 15 QD: Once Daily Dosing, BID: Twice Daily Dosing Results are based on interim data analysis INF904 dosing either once daily (QD) or twice daily (BID) exhibits favorable concentration-time profiles (after 14 days dosing) IN
Slide 16: Agenda: PD Outcome
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part Page 16 AGENDA safety outcome pk outcome pd outcome study design background and pre-clinical work summary
Slide 17: Whole Blood PD Analysis, MAD Part
INF904 – Phase I: Whole Blood PD AnalysisMultiple Ascending Dose (MAD) Part INF904: 30 mg QD INF904: 30 mg BID INF904: 90 mg BID Upon the stimulation with 12.6 nM rhC5a (levels observed in disease state) 24 h 144 h (Day 6) 168 h (Day 7) 312 h (Day 13) 336 h (Day 14) C5a (nM) 30QD 30BID 90BID 30QD 30
Slide 18: Agenda: Summary
INF904: Topline Results from Phase I Multiple Ascending Dose (MAD) Part Page 18 AGENDA safety outcome pk outcome pd outcome study design background and pre-clinical work summary
Slide 19: Summary: Topline Results from INF904 Phase I MAD Study
SummaryTopline Results from INF904 Phase I MAD Study Page 19 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 exposur
Slide 20: Next Steps
INF904: Next Steps Page 20 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 Highlights
Slide 21: InflaRx N.V. Contact Details
Winzerlaer Str. 207745 Jena, Germany Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181 InflaRx N.V. www.inflarx.com
Slide 22: Appendix
Page 22 Pre-clinical data (previously reported) Appendix SAD data (previously reported)
Slide 23: Pre-clinical In Vivo Efficacy Comparison of INF904 to Avacopan
INF904: Potential Best-in-Class C5aR Inhibitor Plasma Concentration Sampled at 8 hours: INF904 = 538 ng/mL Avacopan-like molecule = 119 ng/mL Page 23 PRE-CLINICAL IN VIVO EFFICACY COMPARISON OF INF904 to AVACOPAN* Inhibition of in vivo neutrophil activation by INF904 compared to Avacopan-like molecu
Slide 24: PK Results from SAD Part
INF904 Phase I Study: PK Results from SAD Part Page 24 In comparison to published data for Avacopan, INF904 is approximately 3-fold higher in Cmax and 10-fold higher in systemic exposure (AUClast) for comparable doses (3, 10, 30 mg) Parameter Unit Dose INF904 Avacopan* AUCinf h.ng/ml 3 mg 285 25 10
Slide 25: Safety Results from SAD Part
Page 25 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 active treated subjects. AE severity: Mild: 81 Moderate: 9
Slide 26: 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 Page 26 INF904 blocking activity for C5a-induced neutrophil activation in human plasma achieved set goal and is clearly differentiated from the published blocking activity of the
Slide 27: Summary: Topline Results from INF904 Phase I SAD Study
INF904 confirms its best-in-class C5aR inhibitor potential within this Phase I single ascending dose study Summary Topline Results from INF904 Phase I SAD Study Page 27 Key Outcomes INF904 was well tolerated in treated healthy volunteers and resulted in no safety signals of concern in single ascendi