Slide 1: Phase IIa Pyoderma Gangraenosum Top-Line Results Conference Call
Controlling inflammation Phase IIa Pyoderma Gangraenosum Top-Line Results Conference CallOctober 27, 2021
Slide 2: Important Notice and Disclaimer
Important Notice and DisclaimerThis presentation has been prepared by InflaRx N.V. (“InflaRx”), a US-Nasdaq publicly listed Dutch company having its principal place of business in Germany. This presentation is made for informational purposes only and does not constitute an offer to sell or a solicit
Slide 3: InflaRx Participants
InflaRx Participants 3 Korinna Pilz, M.D., M.Sc.Chief Clinical Development Officer Thomas Taapken, Ph.D.Chief Financial Officer Niels Riedemann, M.D., Ph.D.Chief Executive Officer Jordan ZwickChief Strategy Officer Hoda Tawfik, Ph.D.Senior Program Director Dermatology
Slide 4: Agenda
Overview of Pyoderma Gangraenosum & PGA score Study design and Results Case StudIES
Slide 5: Pyoderma Gangraenosum (PG): An autoimmune condition with high unmet need
Pyoderma Gangraenosum (PG) 5 An autoimmune condition with high unmet need Clinical featuresPG is a rare but potentially life-threatening skin disorder that can lead to chronic, highly painful and difficult-to-treat wounds Many PG patients also suffer from other autoimmune disorders, such as ulcerati
Slide 6: PGA Score – Physician's Global Assessment Score
PGA Score – Physician‘s Global Assessment Score 6 PGA score Description 0 Completely clear except for possible residual hyperpigmentation 1 Almost clear very significant clearance (about 90%); however, patchy remnants of dusky erythema and/or very small ulceration 2 Marked improvement significant im
Slide 7: Phase IIa Study Design
Phase IIa Study Design 7 800mg Group 1 N= 6 Initiation Day 1-8, 3 doses Maintenance Day 15-43, 3 doses PGA ≤ 4 PGA > 4 800mg Q2W Individual titration Day 57-189, 9 doses 1600mg Q2W 800mg Completed Observation Day 219 & 249 800mg Group 2 N= 6 PGA ≤ 4 PGA > 4 1600mg Q2W 2400mg Q2W 1600mg Completed 800
Slide 8: Key Eligibility Criteria
Key Eligibility Criteria 8 Diagnosis of an ulcerative form of pyoderma gangraenosum confirmed by the investigatorMust fulfill at least 3 of 6 PG-defining criteria at screening, including but not limited to pathergy, history of papule, pustule or vesicle that rapidly ulcerated, and clinical examinati
Slide 9: Study Results – Group 1 (Low Dose)
Study Results – Group 1 (Low Dose)PGA-line plot of absolute values over time by patient (Actual days displayed acc. to visit windows) 9 Two patients (02 and 05) achieved complete remission of target ulcerOne patient (01) with initial response and fluctuating PGAPatients 02 and 05 stopped treatment b
Slide 10: Study Results – Group 2 (Medium Dose)
Study Results – Group 2 (Medium Dose)PGA-line plot of absolute values over time by patient (Actual days displayed acc. to visit windows) 10 One patient (10) out of four healed upon up-titration to 2400mg group on day 57 with PGA = 0 since visit 12 (closure of large target ulcer area)Two patients sho
Slide 11: Study Results – Group 3 (High Dose)
Study Results – Group 3 (High Dose)PGA-line plot of absolute values over time by patient (Actual days displayed acc. to visit windows) 11 Six patients out of 7 achieved PGA score of ≤ 1 (remission)One patient (18) experienced target ulcer area decrease >50%; however, new PG lesions developedPatient
Slide 12: Study Results – Group 1 and Group 2 C5a levels
Study Results – Group 1 and Group 2C5a levels 12 Patient 10 in Group 2 reached clinical remission at Day 99 after uptitration to 2400mg at Day 57 Clinical observations Group 1 Group 2 1* 2** 3* 4* 5** 6* 7* 11 8* 12 9 10** Patient Number Patient Number Patients 6, 9, and 10 were uptitrated on day 57
Slide 13: Study Results – Group 3 C5a levels
13 Clinical observations Six patients reached PGA≤1Patient 18 only showed minor improvement of target ulcer but no remission 13 ** 14 ** 15 ** 16 ** 17 ** 18 19 ** Patient Number ** Responder in remission (PGA ≤1) Values not available Study Results – Group 3C5a levels
Slide 14: Summary and Conclusion
Summary and Conclusion 14 Vilobelimab Q2W shows good safety and tolerabilityEvidence for dose-dependent drug activity in PG No infusion-related reactions observedFor 2 patients, related SAEs were reported:Erysipelas leading to hospitalization (judged as non-related by sponsor) Rash due to delayed hy
Slide 15: Patient Case Studies
Patient Case Studies
Slide 16: Patient Case Study
Patient 10 Case Study 16 MH: PG since Jun 2019, Hypertension since 1998; Study Day 1: Feb 2021 Cohort 2: 1600 mg Q2W, individual uptitration to 2400 mg at D57, treatment completedPrevious PG medication: Methylprednisolone only in Jun 2019, Dapsone Jun 2019- Aug 2020, Cyclosporine Oct 2019- Aug 2020
Slide 17: Patient Case Study
Patient 14 Case Study 17 MH: PG since October 2018, Obesity since longer time (no exact day available)Treatment Start: February 2021 Cohort 3: 2400 mg Q2W treatment completedPrevious PG medication: Ciclosporin and methylprednisolone October 2018 – September 2019, failed. Dapsone September 2020 – Nov
Slide 18: Patient Case Study
Patient 13 Case Study 18 MH: PG since August 2020, Psoriasis since 2017Treatment Start: March 2021Previous PG medication: None Cohort 3: 2400 mg Q2W up to Day 85 exclusion after 9 doses due to delayed availability of pos. baseline TB testing result (no TB activation!) Concomitant Medication: Adali
Slide 19: Q&A
Q&A
Slide 20: Contact details, InflaRx N.V. Investor Relations
Winzerlaer Str. 207745 Jena, GermanyEmail: info@inflarx.comTel: +49-3641-508180Fax: +49-3641-508181www.inflarx.com Jordan ZwickChief Strategy OfficerEmail: jordan.zwick@inflarx.de InflaRx N.V. Investor Relations InflaRx N.V.