Trevi Therapeutics, Inc. · NASDAQ:TRVI
Trevi Therapeutics — Investor Presentation (January 2022)
22 slides from Trevi Therapeutics's investor presentation, January 2022
Slide 1: Corporate Presentation
Corporate Presentation January 2022
Slide 2: Forward-Looking Statements Disclaimer
Forward-Looking Statements Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1
Slide 3: Executive Summary
Executive Summary Only oral dual acting MOA in clinical development that works both peripherally and centrally Differentiated to rebalance the kappa and mu receptors, both of which are important in mediating pruritus MOA and cough Statistically significant pruritus reduction in uremic pruritus Ph2b/
Slide 4: HADUVIO Advancing Two Lead Clinical Programs with Expected Readouts 1H 2022
HADUVIO™ (nalbuphine ER) Advancing Two Lead Clinical Programs with Expected Readouts 1H 2022 Pruritus Associated with Prurigo Nodularis1 Chronic Cough in Idiopathic Pulmonary Fibrosis Phase 1 2 3 Filed Phase 1 2 3 Filed Pruritus in PN Chronic Cough in IPF • Enrollment to end January 31, 2022 • Phase
Slide 5: Attractive Categories for Lead Indications
Attractive Categories for Lead Indications Pruritus Associated with Prurigo Chronic Cough in Idiopathic Nodularis Pulmonary Fibrosis ✓•• No approved therapies ✓ • No approved therapies ✓ No oral option available ✓ • No oral option available ✓• High unmet need ✓ • High unmet need ✓• PN is a serious,
Slide 6: Broad Applications for Mechanism of Action of HADUVIO
Broad Applications for Mechanism of Action of HADUVIO™ 6
Slide 7: HADUVIO Acts by Rebalancing Kappa (KOR) and Mu (MOR) Pathways to Regulate Itch and Cough
HADUVIO™ Acts by Rebalancing Kappa (KOR) and Mu (MOR) Pathways to Regulate Itch and Cough Normal State Imbalanced State HADUVIO Pruritic or Cough Rebalancing Too little KOR activation and/or Dual action as both a KOR too much MOR activation agonist and a MOR antagonist HADUVIO KOR Ligands MOR MOR Ac
Slide 8: HADUVIO Showed Durable Results in Itch Across Multiple Studies and Endpoints
HADUVIO™ Showed Durable Results in Itch Across Multiple Studies and Endpoints Over 400 subjects studied with moderate to severe pruritus UP Ph2b/3 Primary Endpoint (N=373) UP Open Label Extension Study (N=166) Uremic Pruritus (UP) 1 All Patients Severe Patients (Baseline NRS ≥7) 6.00 5.59 Baseline S
Slide 9: Chronic Pruritus in Prurigo Nodularis
Chronic Pruritus in Prurigo Nodularis
Slide 10: Opportunity to be the First Oral Therapy Approved in Pruritus Associated with Prurigo Nodularis
Opportunity to be the First Oral Therapy Approved in Pruritus Associated with Prurigo Nodularis Current PN Prevalence Itch Trigger 1,2,3,4 U.S. 300k Itchy Skin 5 WW 730k • Current off-label treatments for itch lack efficacy and/or have an unfavorable AE profile Nodules = ITCH-SCRATCH Chronic • We be
Slide 11: Results from Ph2a Prurigo Nodularis Trial and Open Label Extension
Results from Ph2a Prurigo Nodularis Trial and Open Label Extension (OLE) Continued Separation of WI-NRS Over Time Dose Response Supporting 162mg Selection† 1 All Patients (MITT/LOCF): N = 62 Completing Patients : N = 50 WI-NRS Change from Baseline 0.0 Score from Baseline -0.5 Mean Δ in WI-NRS 8 -1.0
Slide 12: Phase 2b/3 PRISM Trial Design (N=360)
Phase 2b/3 PRISM Trial Design (N=360) Top-Line Data Expected 1H 2022 Optimizations from Ph2a to Ph2b/3 PRISM Trial Increased Powering Enriched Population Increased Duration Focusing on severe population 63 patients (Ph2a) → 360 patients (Ph2b/3) 10 weeks (Ph2a) → 14 weeks (Ph2b/3) WI-NRS ≥5 (Ph2a) →
Slide 13: Patient Images from PRISM
Patient Images from PRISM HADUVIO 162mg BID or Placebo HADUVIO 162mg BID Baseline Week 14 Week 52 Baseline Week 14 Week 28 The images provided are from two separate patients. 13
Slide 14: Potential Market Opportunity Across a Broad Array of Chronic Pruritic Conditions
Potential Market Opportunity Across a Broad Array of Chronic Pruritic Conditions ~$20B Total Market 20261 Global Pruritus Category $20B1 Multiple Sclerosis HIV Protease PN Post Herpetic Inhibitor Induced $3.2B2 Pruritus Pruritus Chemotherapy Burn Induced Hepatitis C Induced Pruritus Pruritus Cancer
Slide 15: Chronic Cough in Idiopathic Pulmonary Fibrosis
Chronic Cough in Idiopathic Pulmonary Fibrosis
Slide 16: Opportunity to be First in Class for Chronic Cough in Idiopathic Pulmonary Fibrosis
Opportunity to be First in Class for Chronic Cough in Idiopathic Pulmonary Fibrosis Current IPF Prevalence 1,2 U.S. 130k 3 Worldwide 1M+ Most Bothersome Daily IPF % of patients that experience Symptom5 symptom on a daily basis 60% 60% 50% 50% • 70% to4 85% of IPF patients are reported to suffer from
Slide 17: Nalbuphine ER has the Potential to Work at Multiple Pathways in IPF Chronic Cough
Nalbuphine ER has the Potential to Work at Multiple Pathways in IPF Chronic Cough Mu, kappa and delta receptors are found in the respiratory regions of the brain stem, lung and peripheral lung nerves Endogenous opioids are believed to play an important role in modulating respiration1 Nalbuphine prev
Slide 18: Chronic Cough in IPF Recruiting in the UK
Chronic Cough in IPF Recruiting in the UK Phase 2a Trial (Enroll 60 patients with 44 Completers) 2 Double-Blind Crossover Treatment Periods Planned interim statistical update expected 1Q 2022 Each Followed by a Washout Period Randomization Primary endpoint • Mean percent change in daytime cough freq
Slide 19: Potential Market Opportunity Across a Broad Array of Chronic Cough Conditions
Potential Market Opportunity Across a Broad Array of Chronic Cough Conditions ~$10B Total Potential Refractory Chronic Addressable Cough / Unexplained COPD Market Emphysema 20271 Chronic Cough Refractory Chronic Chronic Bronchitis Cough GERD Heart Failure Interstitial Lung Diseases Idiopathic Non-sp
Slide 20: Upcoming Milestones 2022—Key Data readouts in 1H
Upcoming Milestones 2022—Key Data readouts in 1H Date Milestone Jan 31, 2022 PRISM (Pruritus in PN Phase 2b/3) Enrollment Ends 1Q 2022 CANAL (Cough in IPF Phase 2) Interim Statistical Update Results 1H 2022 CANAL Topline Data 1H 2022 PRISM Topline Data 20
Slide 21: Trevi Value Proposition
Trevi Value Proposition Dual acting MOA in clinical development that works both peripherally and centrally Rebalancing the to rebalance the kappa and mu receptors, both of which are important in mediating Itch/Cough Pathway pruritus and cough Statistically significant pruritus reduction in uremic pr
Slide 22: Thank You
Thank You trev! THERAPEUTICS
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