Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — Investor Presentation (December 2019)
19 slides from Hepion Pharmaceuticals's investor presentation, December 2019
Slide 1: Corporate Presentation 2019
1 C O R P O R AT E P R E S E N TAT I O N • 2 0 1 9 Nasdaq: HEPA Nasdaq: HEPA
Slide 2: Forward-Looking Statements
Forward-Looking 2 Statements This presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,
Slide 3: Snapshot
Snapshot 3 A Liver Disease Company Committed to developing pleiotropic drug therapy for treatment of chronic liver diseases, including NASH (non- alcoholic steatohepatitis) and other liver diseases (HBV, HCV, HDV) “…Nearly 45% of all deaths in the developed world are attributed to some type of chron
Slide 4: Corporate Overview
Corporate Overview 4 Lead Asset CRV431: Novel, high-potency, cyclophilin inhibitor that targets multiple stages of liver disease, including NASH • Anti-fibrotic, anti-viral, and anti-cancer properties (pleiotropic) • Strong preclinical proof of concept • Strong safety profile in preclinical and Phas
Slide 5: Development Phase
Development Phase 5 Discovery Phase 1 Phase 3 CRV431 Preclinical Phase 2 • IND for HBV – Phase 1 Single Ascending Dose completed • IND for HBV – Multiple Ascending Dose in progress, Q3-2019 • IND for NASH – Approved, Q3-2019 “In our large combined tertiary center cohorts, patients with concomitant N
Slide 6: CRV431 in NASH
CRV431 in NASH 6 Cyclophilin Inhibitors Target Multiple Liver Disease Stages INJURY/STEATOSIS INFLAMMATION FIBROSIS CIRRHOSIS/CANCER • Antiviral activity • Suppress pro-inflammatory • Reduce collagen production • Block cancer cell adaptation (HBV, HCV, HDV, HIV-1) pathways mediated by from hepatic s
Slide 7: Anti-Fibrotic Activity in NASH Models
Anti-Fibrotic Activity in NASH Models 7 STAM Mouse Model “Friedman” Mouse Model (High fat diet + streptozotocin) (Western diet + CCl4) 3 - 11 weeks oral CRV431 treatment 6 weeks oral CRV431 treatment p < 0 .0 1 P≤0.0001 p = 0 .0 3 p = 0 .0 1 10 4 6 S ir iu s r e d - p o s itiv e fib r o s is S ir iu
Slide 8: Anti-Fibrotic Activity in Liver Toxin Models
Anti-Fibrotic Activity in Liver Toxin Models 8 Rat Thioacetamide Model Carbon Tetrachloride Mouse Model 9 weeks thioacetamide 6 weeks CCl4 9 weeks vehicle or CRV431 6 weeks vehicle, CRV431, or obeticholic acid (OCA) Fibrosis (% Sirius Red) Fibrosis (% Sirius Red) Fibrosis score P = 0.008 15 P=0.008
Slide 9: Anti-Cancer Activity in Late-Stage NASH Model
Anti-Cancer Activity in Late-Stage NASH Model 9 STAM Mouse Model Number of Tumor Nodules p = 0.05 (streptozotocin + high fat diet) 15 Number of nodules per liver 10 Score 0 5 10 weeks oral CRV431 treatment 0 Vehicle CRV431 p = 0.014 44% reduction in tumor number 5 Sirius red-positive fibrosis Score
Slide 10: CRV431 on Human Precision Cut Liver Slices
CRV431 on Human Precision Cut Liver Slices 10 CRV431 Decreases Inflammation and Fibrosis (UK Study Group) Picrosirius Red Staining of Fibrotic Collagen CONCLUSIONS • TGFβ +PDGF stimulation increased inflammation and fibrosis Percentage area stained (%) 12 Time 0 (baseline) markers, and TGFβ/PDGF rec
Slide 11: Anti-Fibrotic Mechanisms of Action
Anti-Fibrotic Mechanisms of Action 11 CRV431 is proposed to decrease fibrosis by affecting two processes in hepatic stellate cells, the primary, collagen-producing cell type in hepatic fibrosis: • decrease expression of fibrosis-related genes • decrease cyclophilin B-dependent collagen synthesis and
Slide 12: Summary of Nonclinical Anti-fibrotic Activities
Summary of Nonclinical Anti-fibrotic Activities 12 Treatment Fibrosis Reduction Species Model Location Other CRV431 Effects Duration (% Sirius Red) Friedman NASH model Mice Scripps (USA) 6 weeks 82% Weight gain (CCl4 + Western diet) STAM NASH model Mice Stelic (Japan) 3 weeks 57% none (strepto
Slide 13: Single Ascending Dose (SAD) Study
Single Ascending Dose (SAD) Study 13 (CTRV-CRV431-101) Objectives • To evaluate the safety and tolerability of single oral doses of CRV431 at increasing dose levels • To evaluate the pharmacokinetics of CRV431 Design • Randomized, Partially blinded, Placebo-controlled, sequential SAD Study in health
Slide 14: CRV431 Mean Pharmacokinetic Parameters
CRV431 14 Mean Pharmacokinetic Parameters AUC0-inf, Tmax, h Cmax, ng/mL t½, h Dose (range) (SD) ng*h/mL (SD) (SD) 75 mg 4 (2-10) 334±106 20,917±3,780 73.6±15.2 225 mg 1.3 (1-2) 1,368±221 84,422±32,373 97.3±18.4 375 mg 1.5 (1-3) 1,488±176 103,833±30,916 110.8±36.2 525 mg 1 (1-1) 1,655±250 102,087±43,
Slide 15: Safety Profile and Conclusions
Safety Profile and Conclusions 15 SAD Study Safety Profile • No SAE’s were reported in the SAD Study • AE’s from the SAD study have been mild to moderate and mostly unrelated to study drug • There were no Grade 3 or Grade 4 laboratory abnormalities • Vital signs and ECGs were unremarkable Conclusion
Slide 16: CRV431 Advantages in Treating Liver Disease
CRV431 Advantages 16 in Treating Liver Disease • Cyclophilin inhibitor (inhibits peptidyl prolyl isomerase) • Broad range of liver-protective mechanisms (pleiotropic) due to targeting multiple cyclophilins • The only investigational drug targeting both viral hepatitis and liver disease • Later-stage
Slide 17: Clinical Timelines/Events
Clinical Timelines/Events 2019 17 NASH IND, authorization to proceed Initiated Clinical 28-day study, oral CRV431 escalating dose, once daily repeat doses 2020 H1 • Data from Clinical 28-day study, oral CRV431 Multiple Ascending Dose (MAD), once daily • Initiate Phase 2 NASH biomarker pilot stud
Slide 18: Non-Clinical Events
Non-Clinical Events 2019 18 Data from Human Precision Cut Liver Slice culture 2019 H2 • Data from In-house in vitro - stellate cells • Ongoing Mode of Action studies, ongoing and collaborations Q4 Data from rat thioacetamide, fibrosis study Data from NASH Western Diet, fibrosis study • Data fr
Slide 19: Thank You
19 Thank You Corporate Contact: Investor Relations: Robert Foster Stephen Kilmer rfoster@hepionpharma.com skilmer@hepionpharma.com Tel: 646.274.3580 Nasdaq: HEPA
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