Inventiva Sa · EURONEXT:IVA
Inventiva Sa — Investor Presentation (March 2018)
27 slides from Inventiva Sa's investor presentation, March 2018
Slide 1: Developing breakthrough therapies in NASH, systemic sclerosis and MPS
Developing breakthrough therapies in NASH, systemic sclerosis and mucopolysaccharidosis (MPS) Corporate Presentation March 2018
Slide 2: Disclaimer
DISCLAIMER This document has been prepared by Inventiva (the "Company") solely for use at this presentation. By attending the meeting where this presentation is made, or by reading the following presentation slides, you agree to be bound by the following limitations, qualifications and restrictions:
Slide 3: Inventiva: a clinical stage biopharma with a focus on fibrosis
Inventiva: a clinical stage biopharma with a focus on fibrosis Three late stage clinical programs Two royalty bearing collaborations with AbbVie and Boehringer Ingelheim Pre-clinical pipeline in oncology and fibrosis Listed on Euronext Paris: 59M€ of cash financing the company until mid-19 Strong sh
Slide 4: Lanifibranor NASH and SSc
Lanifibranor NASH and SSc A new generation pan-PPAR agonist for a safe and efficacious treatment of fibrotic conditions
Slide 5: Lanifibranor: a next generation panPPAR agonist for fibrotic conditions
Lanifibranor: a next generation panPPAR agonist for a safe and efficacious treatment of fibrotic conditions Oral drug. 100 volunteers treated in phase I trials and 56 patients treated in phase IIa study Phase IIb ongoing in NASH and systemic sclerosis (SSc) NASH SSc • PPAR clinically validated targe
Slide 6: A good safety profile differing from previously developed PPARs
A good safety profile differing from previously developed PPARs Different profile than other PPAR: moderate and balanced activity Lanifibranor binds differently than rosiglitazone into the PPARg ligand binding domain Phase I and II studies underline the excellent tolerability of lanifibranor • Good
Slide 7: Phase IIa studies demonstrated efficacy on key metabolic markers
Phase IIa clinical studies demonstrated lanifibranor efficacy on key metabolic markers Lanifibranor (IVA337) strongly improves metabolic markers Insulin resistance (HOMA-IR, adiponectin) Dyslipidemia (increase in HDL-C, reduction of TG) Adiponectin (PPARg) HDL Cholesterol (PPARa) Triglycerides (
Slide 8: Lanifibranor reduces steatosis, inflammation, ballooning and fibrosis in preclinical models
Lanifibranor strongly reduces steatosis, inflammation, ballooning and fibrosis in preclinical models Lanifibranor inhibits steatosis Lanifibranor strongly reduces and inflammation in the MCD ballooning and the NAS score Lanifibranor reverses model in the foz/foz model established liver fibrosis Live
Slide 9: Mechanism of action addressing all the key features of NASH
Lanifibranor: a mechanism of action addressing all the key features of NASH PPARa,g PPARa,g Metabolism Steatosis Insulin sensitivity FA uptake HDLc FA catabolism Lanifibranor TG Lipogenesis Moderate and balanced panPPAR agonist activity regulating genes in: • PPARa: hepatocytes • PPARd: kuppfer cell
Slide 10: NATIVE Phase IIb in NASH
NATIVE Phase IIb in NASH Trial design Status Inclusion criteria Trial enrolling Liver biopsy Randomisation Moderate to severe patients with a inflammation and 1/1/1, stratification on T2DM patients ballooning score of 3 or 4 Study powered with 75 patients per group Steatosis score ≥ 1 an
Slide 11: NATIVE: Phase IIb in NASH countries worldwide
NATIVE: Phase IIb in NASH 16 countries worldwide ► 13 in EU Principal investigator: Pr Sven Francque, Belgium ► Canada ► Australia ► Mauritius 14 countries approved 76 sites involved 45 sites activated 42 sites screening Results expected second-half 2019 Full Year 2017 Presentation Non-confidential
Slide 12: Systemic sclerosis overview
Systemic sclerosis overview A severe disease: 50% of patients will die within 10 years from the first diagnosis(1) No approved treatment More than 170,000 patients diagnosed and a market potential > €1.8bn (2) Clear regulatory pathway with the MRSS (Modified Rodnan Skin Score) accepted as approval e
Slide 13: Lanifibranor addresses all the relevant clinical features of systemic sclerosis
Lanifibranor addresses all the relevant clinical features of systemic sclerosis Lanifibranor reduces vasculopathy and inflammatory driven lung fibrosis Lanifibranor reduces Lung Skin established skin fibrosis Lanifibranor restores lung Lanifibranor reduces right ventricular functional capacity Heart
Slide 14: FASST Phase IIb in SSc
FASST Phase IIb in SSc Trial design Status Inclusion criteria Last patient recruited in October 2017. MRSS (Modified Rodnan Skin Score) between 10 and 25 SSc diagnosed from less than 3 years Clinicaltrials.gov identifier: NCT02503644 Primary endpoint Mean change of the MRSS from baseline t
Slide 15: FASST: 100% of patients randomized and close to 50% completed
FASST: 100% of patients randomized and close to 50% of patients have already completed the trial(1) 180 160 140 120 100 80 161 145 60 (100%) 102 40 72 (49%) 20 0 # of patients screened # of patients randomised # of patients with 6 months # of patients having of treatement completed the trial (12 mon
Slide 16: Lanifibranor a phase III ready program in SSc and NASH by 19
Lanifibranor a phase III ready program in SSc and NASH by 2019 2015 2016 2017 2018 2019 H2 H1 H2 H1 H2 H1 H2 H1 H2 EMA conditional marketing authorisation Systemic sclerosis submission Phase IIb FDA potential breakthrough therapy status FDA preIND Results FDA IND Start of pivotal Phase III study (EU
Slide 17: Odiparcil
Odiparcil The first oral therapy to treat five forms of mucopolysaccharidosis (MPS): MPS I, II, IV, VI and VII
Slide 18: Odiparcil, the first oral therapy for several forms of MPS
Odiparcil, the first oral therapy for several forms of MPS Oral drug with large phase I and phase II clinical package Novel mechanism of action allowing to reduce intra-cellular GAG content Efficacious in tissues and organs not treated by enzyme replacement therapies Potential to replace ERT in MPS
Slide 19: Odiparcil potential to differentiate versus current enzyme replacement therapies
Odiparcil has the potential to positively differentiate versus current enzyme replacement therapies Aldurazyme, Elaprase, Odiparcil Naglazyme, Vimizim, Mepsevii HSCT (Hematopoietic stem cell transplantation) Effect on mobility Eye, cartilage, bones, heart valves, spinal cord compression Safety Dose
Slide 20: Observational study to evaluate intracellular GAG in leukocytes
Inventiva’s observational study to evaluate intracellular GAG in leukocytes Leukocytes are promising cells ► Low invasiveness of collection procedure ► GAG intracellular levels are increased in animal model of MPS ► Odiparcil decreases intra-cellular GAG level Objectives of Inventiva’s non-intervent
Slide 21: Study confirms a promising biomarker for MPS VI
Study confirms Inventiva has developed a promising biomarker for MPS VI and the limited ERT efficacy in reducing leukoGAGs ARSB activity in leukocytes is MPS VI patients treated with MPS VI patients treated with ERT have increased by 8 fold after ERT ERT have increased CS (and DS increased CS and DS
Slide 22: Odiparcil iMProveS phase IIa study in MPS VI patients
Odiparcil iMProveS phase IIa study in MPS VI patients Trial design ► Inclusion criteria: MPS VI patients (≥ 16 year-old) and treated with ERT for more than 6 months ► Status: First patient recruited December 2017. 18 patients double blind + 6 patients open label 6 weeks 4 weeks 26 week treatment 10
Slide 23: Odiparcil overall development plan in MPS VI
Odiparcil overall development plan in MPS VI 2016 2017 2018 2019 2020 2021 2022 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 Biomarker study Phase IIa Clinic Results Phase Ib (MPS VI Pivotal Phase III children) EMA Scientific Regulatory EU ODD EMA PIP EMA SA PIII Advice Dev Plan US ODD Rare paediatric FDA Eo
Slide 24: Two collaborations with leading pharma companies
Two collaborations with leading pharma companies
Slide 25: Two successful collaborations with AbbVie and Boehringer Ingelheim
Two successful collaborations in place with AbbVie and Boehringer Ingelheim RORγ collaboration Collaboration in fibrosis RORγ program addresses large markets currently Multi-year R&D collaboration and licensing partnership dominated by biologics Joint team until pre-CC stage. BI to take full
Slide 26: Near-term catalysts
Near-term catalysts
Slide 27: Key 2017 achievements and near-term catalysts
Key 2017 achievements and near-term catalysts 2017 2018 2019 12 month monkey study finalized Last patient phase IIb NASH Results Phase IIb SSc Lanifibranor Lanifibranor INN name from WHO 2 year carcinogenicity study results Results Phase IIb NASH Last patient phase IIb SSc SSc IND