Slide 1: INF904: Topline Results from Phase I SAD Study
INF904: TOPLINE RESULTS FROM PHASE I SAD STUDY SEPTEMBER 2023
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 THOMAS TAAPKEN, PH.D. Chief Financial Officer, InflaRx CAMILLA CHONG, M.D. Chief Medical Officer, InflaRx Page 4
Slide 5: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 5
Slide 6: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 6
Slide 7: 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 cells, mediates the major pathophysiological effects of C5a. Cardiology Pulmonology ➢ B
Slide 8: 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 hypothetical of neutrophil
Slide 9: INF904: Pre-clinical Summary
INF904: Pre-clinical Summary C5a INF904 Facts • Chemistry: Amorphous solid (high exposure potential). Trp213 (human, primate, hamster) • INF904 binds to a well-defined allosteric site in C5aR. • INF904 has a novel Markush structure. • US patent was issued in October 2021; national phases for other s
Slide 10: Potential Best-in-Class C5aR Inhibitor
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 11: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 11
Slide 12: INF904 Phase I Study Design
INF904 Phase I Study Design Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) 3mg Safety evaluation • Enrollment ongoing SAD • Total enrolled: n = 62 (N=8, in 6:2 ratio) 10mg Safety evaluation SAD (N=8, in 6:2 ratio) Dose 1 Safety evaluation MAD 30mg Safety evaluation N=8 (in 6:2 ratio) SAD
Slide 13: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 13
Slide 14: 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 15: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 15
Slide 16: INF904 Phase I Study: PK Results from SAD Part
INF904 Phase I Study: PK Results from SAD Part 1,400 Avacopan INF904 30mg 3mg Parameter Unit Dose INF904 Avacopan* INF904 3mg INF904 10mg AUCinf h.ng/ml 3 mg 285 25 1,200 INF904 10mg INF904 30mg INF904 30mg 10 mg 1264 130 INF904 60mg INF904 60mg 1,000 INF904 INF904 120mg 120mg 30 mg 5956 628 INF904
Slide 17: INF904 Phase I Study: PK Summary from SAD Part
INF904 Phase I Study: PK Summary from SAD Part HIGHLIGHTS • Exposure to INF904 is sustained with a time to maximum concentration (tmax) at 6 hours. • INF904 is dose proportional for systemic exposure over the dose range 3 – 240 mg (AUClast) and nearly dose proportional for maximum concentration (Cma
Slide 18: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 18
Slide 19: INF904 Phase I Study: PD Results from SAD Part
INF904 Phase I Study: PD Results from SAD Part C5a-mediated CD11b up-regulation 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 120 • INF904: In response to 12.64 nM of C5a, % C hange on C D 11b Level 100 P la c e b o ≥ 90% blocking activity was observed in
Slide 20: Agenda
INF904: Topline Results from Phase I Single Ascending Dose (SAD) Part AGENDA BACKGROUND AND PRE-CLINICAL WORK STUDY DESIGN SAFETY OUTCOME PK OUTCOME PD OUTCOME SUMMARY Page 20
Slide 21: 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. INF904 demonstrated a strong C5a bl
Slide 22: Next Steps for INF904
Next Steps for INF904 Phase I MAD study ongoing; data available to be presented at the end of Q4 2023 / early Q1 2024. Ongoing scientific and strategic work within select disease areas for future development. Work ongoing to optimize formulation for ideal manufacturing and dosing convenience. Work o
Slide 23: 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