Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — ContraVir Pharmaceuticals — Investor Presentation (June 2019)
20 slides from Hepion Pharmaceuticals's investor presentation, Jun 11, 2019
Slide 1: Forward-Looking Statements
Forward-Looking Statements 2 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 2: Snapshot: A Liver Disease Company
Snapshot 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) 3 “…Nearly 45% of all deaths in the developed world are attributed to some type of chroni
Slide 3: Corporate Overview
Corporate Overview Product CRV431: Novel, high-potency, cyclophilin inhibitor that targets multiple stages of liver disease, including NASH 4 • • • • • • Anti-fibrotic, anti-viral, and anti-cancer properties (pleiotropic) Strong preclinical proof of concept Strong safety profile in preclinical and P
Slide 4: Structure: A cyclic undecapeptide built off voclosporin experience
CRV431 Structure 5 A cyclic undecapeptide, built off our voclosporin experience AA1 chemical modification decreases immunosuppression R1 HO AA3 chemical modification enhances cyclophilin binding O O H N N R2 N N N O O O O O O N H N H N AA1 chemical modification increases immunosuppression N CH2 N H
Slide 5: Development Phase
Development Phase 6 Discovery Phase 1 Phase 3 CRV431 Preclinical Phase 2 • • IND for HBV – Phase 1 Single Ascending Dose completed IND for HBV – Multiple Ascending Dose initiation expected, Q2, 2019 in patients IND for NASH – Expected approval, Q3, 2019 • “In our large combined tertiary center cohor
Slide 6: Cyclophilin Inhibitors Target Multiple Liver Disease Stages in NASH
CRV431 in NASH Cyclophilin Inhibitors 7 Target Multiple Liver Disease Stages INJURY/STEATOSIS INFLAMMATION Suppress pro-inflammatory pathways mediated by extracellular cyclophilin A binding to CD147 FIBROSIS Reduce collagen production from hepatic stellate cells Reduce collagen hydroxyl-ation and cr
Slide 7: Anti-Inflammatory/Steatosis Efficacy in STAM Murine NASH Model
CRV431 Anti-Inflammatory/Steatosis 8 Efficacy in STAM Murine NASH Model 3, 6, or 11 weeks oral CRV431 treatment p = 0. 0 3 10 10 10 8 8 8 6 6 6 4 4 4 2 2 2 0 0 0 20 m g / k g / da y C R V 431 V e h ic le 5 m g / k g / da y C R V 431 V e h ic le 50 m g / k g / da y C R V 431 V e h ic l e 50 m g / k g
Slide 8: Anti-Fibrotic Efficacy in STAM Murine NASH Model
CRV431 Anti-Fibrotic 9 Efficacy in STAM Murine NASH Model 3, 6, or 11 weeks oral CRV431 treatment p < 0. 0 1 p = 0.014 p = 0. 0 3 p = 0. 0 1 2 . 5 5 4 6 2 . 0 4 3 4 1 . 5 3 2 1 . 0 2 2 1 0 . 5 1 0 . 0 0 0 0 20 m g / k g / da y C R V 431 V e h ic le 5 m g / k g / da y C R V 431 Vehicle 50 mg/ kg/day
Slide 9: Anti-Fibrotic Efficacy in Carbon Tetrachloride Murine Model
CRV431 Anti-Fibrotic 10 Efficacy in Carbon Tetrachloride Murine Model P = 0.008 6 weeks carbon tetrachloride (i.p.) + drug treatment (oral): P = 0.32 • • • • Vehicle CRV431 50 mg/kg/day Obeticholic acid (OCA) 10 mg/kg/day CRV431 50 mg/kg/day + OCA 10 mg/kg/day 4 3 Assess liver fibrosis by Sirius Red
Slide 10: Liver morphology in NASH Mice
CRV431 for Liver Disease 11 Liver morphology in NASH Mice Vehicle treatment, 11 weeks (enlarged fatty liver) CRV431 treatment, 50 mg/kg, PO, 11 weeks (normalized liver) Nasdaq: CTRV
Slide 11: Putative Anti-Fibrotic Mechanism of Action
Putative Anti-Fibrotic Mechanism of Action 12 Collagen reduction Nasdaq: CTRV R e la tiv e ex p r es s ion v s D M S O L ysyl O x i d ase ( L O X ) G en e E xp r ess i o n 2 .5 2 .0 1 .5 1 .0 0 .5 0 .0 •Role of cyclophilins in formation of collagen involved in at least two ways: 1.Peptidyl prolyl is
Slide 12: Anti-Cancer Activity in NASH Mice
CRV431 Anti-Cancer 13 Activity in NASH Mice 10 weeks oral CRV431 treatment T u m o r S c o r e ( n u m b er x p = 0. 02 si z e ) N um be r of Tum or N odu l e s p = 0. 05 15 Score = 0 (no nodules) 7 6 5 10 4 3 Score = 7 (many large nodules) 5 2 1 0 0 V e h ic le C R V 431 V e h ic le C R V 431 STUDY
Slide 13: Single Ascending Dose (SAD) Study (CTRV-CRV431-101)
Single Ascending Dose (SAD) Study (CTRV-CRV431-101) Objectives 14 • • 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: Mean Pharmacokinetic Parameters
CRV431 15 Mean Pharmacokinetic Parameters (SD) • • Drug exposure is linear up to 375mg (r2=0.914) Pharmacokinetic profile supports once daily dosing. Nasdaq: CTRV Dose Tmax, h (range) Cmax, ng/mL (SD) AUC0-inf, ng*h/mL (SD) t½, h 75 mg 4 (2-10)334±10620,917±3,78073.6±15.2 225 mg 1.3 (1-2)1,368±22184
Slide 15: Safety Profile and Conclusions
Safety Profile and Conclusions SAD Study 16 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: Advantages in Treating Liver Disease
CRV431 Advantages in Treating Liver Disease 17 • • • • First-in-class 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 dise
Slide 17: Viral Hepatitis: Anti-HBV and HCV Activities
Viral Hepatitis Anti-HBV and HCV Activities 18 CRV431 anti-viral activities toward hepatitis B virus (HBV) and hepatitis C virus (HCV) expected to reduce liver disease arising from viral hepatitis HBV CRV431 decreases several HBV markers in cell culture and an animal model, including HBV DNA, HBsAg,
Slide 18: Planned Next Steps
CRV431 Planned Next Steps 19 • Clinical 28-day study, oral CRV431 escalating dose, once daily. Initiate Q2, 2019 with data Q4, 2019 • HBV patients with <F2, administered escalating doses of CRV431 (75, 150, 225, 375 mg), plus 300 mg tenofovir disoproxil fumarate (TDF). One additional fibrosis F2/F3
Slide 19: Thank You
20 Thank You Corporate Contact: Robert Foster rfoster@contravir.com Investor Relations: Stephen Kilmer skilmer@contravir.com Tel: 646.274.3580 Nasdaq: CTRV
Slide 20: Thank You
Thank You Corporate Contact: Investor Relations: Robert Foster Stephen Kilmer rfoster@contravir.com skilmer@contravir.com Tel: 646.274.3580 Nascac: CTRV © ContraVir
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