Inventiva SA · EURONEXT:IVA
Inventiva SA — J.P. Morgan Healthcare Conference 2022
31 slides from Inventiva SA's conference presentation, January 2022
Slide 1: Developing innovative therapies in NASH and MPS
Developing innovative therapies in NASH and MPS Corporate Presentation January 2022
Slide 2: Safe Harbor
SAFE HARBOR This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, results of operations, business
Slide 3: Key take-aways
Key take-aways Potential First-in Class & Best- A Phase IIb Clinical Stage Strong R&D Capabilities and in-Class NASH Drug Collaboration with AbbVie Cash Position Lanifibranor: only pan-PPAR agonist Cedirogant/ABBV-157 Small R&D capabilities including wholly- in clinical development for NASH molecule
Slide 4: Lanifibranor in Nonalcoholic Steatohepatitis (NASH)
Lanifibranor in Nonalcoholic Steatohepatitis (NASH)
Slide 5: Lanifibranor: a pan-PPAR agonist in phase III development in NASH
Lanifibranor: a pan-PPAR agonist in phase III development in NASH LANIFIBRANOR Moderate and balanced pan-PPAR agonist activity Small molecule that activates all three PPAR isoforms in humans PPARα Differentiated chemical structure: not a fibrate or a TZD Once daily oral administration Positi
Slide 6: Lanifibranor overall development plan in NASH
Lanifibranor overall development plan in NASH CLINICAL DEVELOPMENT Phase III in patients with NASH Registration and F2-F3 fibrosis Phase I Phase IIa Phase IIb (NATIVE) III OVERVIEW • 72 week Part 1 + Part 2 extension IIb DESIGN period • 24 weeks • Inclusion criteria and patient profile in • 800 mg a
Slide 7: Lanifibranor overall development plan in NASH
Lanifibranor overall development plan in NASH CLINICAL DEVELOPMENT Phase III in patients with NASH H2 2024 and F2-F3 fibrosis Headline results Phase I Phase IIa Phase IIb (NATIVE) Phase II H2 2022 in NAFLD patients with T2D Headline results Lani + empagliflozine Phase II H2 2023 in NASH patients wit
Slide 8: The Phase IIb NATIVE trial studied 800 mg and 1200 mg once-daily lanifibranor across 247 patients
The Phase IIb NATIVE trial studied 800 mg and 1200 mg once-daily lanifibranor across 247 patients PHASE IIb DESIGN OVERVIEW 24-week treatment + 4-week follow-up Screening Double blind, randomized, placebo-controlled End of treatment Liver biopsy Liver biopsy Placebo lanifibranor, 800 mg once dai
Slide 9: Lanifibranor is the first candidate to achieve statistically significant results on the two Phase III primary endpoints
Lanifibranor is the first candidate to achieve statistically significant results on the two Phase III FDA and EMA primary endpoints PHASE IIb EFFICACY KEY ENDPOINTS xx Statistically significant xx Non-statistically significant Key Phase IIb results by endpoint N = 247 ITT population N = 197 PP popul
Slide 10: A statistically significant decrease in liver enzymes was observed
A statistically significant decrease in liver enzymes was observed PHASE IIb EFFICACY OTHER Other secondary endpoints in ITT (N = 247) Absolute change from baseline in ALT Absolute change from baseline in AST 10 10 Mean absolute change (UI/L) Mean absolute change (UI/L) 0 0 -10 -10 -20 ** * ** ** *
Slide 11: Significant change in HDL-cholesterol and triglycerides, no change in LDL-cholesterol
A statistically significant change in HDL-cholesterol and triglycerides was seen, without a change in LDL-cholesterol PHASE IIb EFFICACY OTHER Other secondary endpoints in ITT (N = 247) * p<0.01 **p<0.001 Absolute change from baseline in HDL-C Absolute change from baseline in triglycerides SECONDARY
Slide 12: In NASH and T2D, significant reductions of fasting glucose, insulin, HbA1c
In patients with NASH and T2D, statistically significant reductions of fasting glucose and insulin, HbA1c were observed PHASE IIb EFFICACY OTHER Secondary endpoints in patients with NASH and T2D (N = 103) Absolute change from baseline in HbA1c Absolute change from baseline in fasting glucose 0,5 Mea
Slide 13: Additional analysis on NATIVE phase 2b results enlarged lanifibranor spectrum of efficacy
Addtional analysis on NATIVE phase 2b results have enlarged lanifibranor spectrum of efficacy EFICACY: Sub-analysis Presentation during the plenary session of NATIVE phase 2b trial Lanifibranor effect on histology endpoints is higher in the F2-F3 patients Lanifibranor has beneficial effects on
Slide 14: Lanifibranor has continued to show a favourable safety profile
Lanifibranor has continued to show a favourable safety profile PHASE IIb SAFETY OVERALL Placebo 800 mg 1200 mg N (%) patients reporting Adverse Event (AE) (N = 81) (N = 83) (N = 83) Any Treatment-Emergent AE (TEAE) 50 (61.7%) 59 (71.1%) 62 (74.7%) Drug-related TEAE 19 (23.5%) 25 (30.1%) 23 (27.7%)
Slide 15: A limited number of serious TEAEs occurred
A limited number of serious TEAEs occurred PHASE IIb SAFETY SERIOUS TEAE Patients reporting treatment-emergent Placebo 800 mg 1200 mg Serious AE (SAE); N (%) (N = 81) (N = 83) (N = 83) Total 3 (3.7%) 3 (3.6%) 7 (8.4%) Treatment-Emergent Serious AE linked to biopsy procedure Post-procedural haematoma
Slide 16: NEJM publication link
https://www.nejm.org/doi/full/10.1056/NEJMoa2036205
Slide 17: Lanifibranor compares favourably in targeting both fibrosis improvement and NASH resolution
Lanifibranor compares favourably in its ability to target both fibrosis improvement and NASH resolution EFFICACY Active Placebo xx Statistically significant xx Non-statistically significant Only drug achieving statistical Injectables significance on both endpoints Lanifibranor Ocaliva Resmetirom Ara
Slide 18: The F2-F3 Phase III NATIV3 inclusion criteria and patient profile are in line with NATIVE Phase IIb
The F2-F3 Phase III NATIV3 inclusion criteria and patient profile are in line with the NATIVE Phase IIb trial and is conduced across two parts PHASE III OVERVIEW A randomized, double-blind, placebo-controlled, multicenter, Phase III study evaluating long-term efficacy and safety of lanifibranor in a
Slide 19: Part 1 of Phase III NATIV3 will enable U.S. accelerated approval and EU conditional approval
Part 1 of the Phase III NATIV3 will enable U.S. accelerated approval and EU conditional approval based on a 72-week histology analysis PHASE III OVERVIEW Part 1 F2-F3 Phase III Part 1: 72 week treatment Screening Placebo Biopsy Eligible for U.S. ACCELERATED Biopsy Part I lanifibranor, 800 mg once da
Slide 20: Part 2 of NATIV3 extension will allow broader full approval for lanifibranor in F2-3
Part 2 of the Phase III NATIV3 extension study will allow for a broader “full approval” for lanifibranor in F2-3 PHASE III OVERVIEW Part 2 F2-F3 Phase III Part 2: Extension period Placebo Biopsy Part II Potential for FULL lanifibranor, 800 mg once daily APPROVAL in U.S. and EU lanifibranor, 1200 mg
Slide 21: The Phase III patients will be randomised across more than 330 sites worldwide
The Phase III patients will be randomised across more than 330 sites worldwide PHASE III DESIGN SITE SELECTION Study conducted with our global partner ICON Nativ3 countries 25 countries worldwide expected to participate Corporate Presentation | 2022 Non-confidential – Property of Inventiva │ 21
Slide 22: Lanifibranor clinical trial in patients with NAFLD and T2D
Lanifibranor clnical trial in patients with NAFLD and T2D PHASE II NAFLD T2D TRIAL Objective: Establish safety, efficacy and mechanism of action of lanifibranor in patients with T2D and NAFLD. Specifically determine if lanifibranor decreases IHTG(1), improves hepatic insulin sensitivity, endogenous
Slide 23: Combination of SGLT2 with pioglitazone has shown additional metabolic health benefits
Combination of SGLT2 with pioglitazone has shown additional metabolic health benefits and favorable weight management OUTLOOK SGLT2 combination study Lanifibranor and SGLT2 rationale Four randomized trials – Pioglitazone alone vs pioglitazone + sGLT2i – N = 1411 T2D patients • Centers were in US,
Slide 24: LEGEND Study Design
LEGEND Study Design PHASE II Lani + SGLT2i Lanifibranor in Combination with the SGLT2 Inhibitor empagliflozin in patients with NASH and Type 2 Diabetes LEGEND Study Principal investigator Inclusion criteria Prof. M. Lai, gastroenterologist-hepatologist, Adult patients with diabetes and NASH asso
Slide 25: Cedirogant
Cedirogant
Slide 26: Cedirogant: a clinical stage RORg inverse agonist with potential in several auto-immune diseases (I)
Cedirogant: a clinical stage RORg inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases (I) RORg is believed to be a master regulator of Th17 differentiation and IL-17 expression, an approach validated by several successful biologics Pharmacological inhibition o
Slide 27: Cedirogant: a clinical stage RORg inverse agonist with potential in several auto-immune diseases (II)
Cedirogant: a clinical stage RORg inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases (II) Cedirogant (ABBV-157) is targeting indications where competitors have reached block-buster status Brand Company Target Posology 2020 sales(1) Cedirogant Target Product P
Slide 28: Cedirogant Phase IIb in adults with moderate to severe psoriasis
Cedirogant Phase IIb in adults with moderate to severe psoriasis A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis Status Primary outcome measures
Slide 29: Upcoming milestones
Upcoming milestones
Slide 30: Anticipated key milestones
Anticipated key milestones 2022 2023 2024 Lanifibranor H1 2022 H2 2023 H2 2024 • Activation of first clinical • Headline • Headline sites for the phase II results of results of the trial combining Phase II of phase III trial in lanifibranor with SGLT2i lanifibranor in patients with empaglifloxin com
Slide 31: Contacts
Contacts Inventiva Brunswick Westwicke, an ICR Company Pascaline Clerc Laurence Frost/ Tristan Roquet Montégon / Patricia L. Bank Aude Lepreux VP of Global External Affairs Investor relations Media relations [email protected] [email protected] [email protected] +1 240 620 9