Trevi Therapeutics, Inc. · NASDAQ:TRVI
Trevi Therapeutics — Investor Presentation (July 2021)
28 slides from Trevi Therapeutics's investor presentation, Jul 9, 2021
Slide 1: Investor Presentation July 2021
Investor Presentation July 2021 Exhibit 99.1
Slide 2: Forward-looking statements
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 1995. Such statements are subject to ri
Slide 3: Executive Summary
Executive Summary Differentiated MOA Only oral dual acting MOA in clinical development that works both peripherally and centrally to rebalance the kappa and mu receptors, both of which are important in mediating pruritus and cough Strong Pruritus Data Statistically significant pruritus reduction in
Slide 4: Experienced Leadership with Strong Financial Backing
Experienced Leadership with Strong Financial Backing Shareholders (as of April 19, 2021) Management Team Jennifer Good President & Chief Executive Officer Thomas Sciascia, M.D. Chief Medical Officer William Forbes, Pharm.D. Chief Development Officer Farrell Simon, Pharm.D. VP, Head of U.S. Marketing
Slide 5: Only oral dual acting MOA in clinical development
Only oral dual acting MOA in clinical development that works both peripherally and centrally to rebalance the kappa and mu receptors, both of which are important in mediating pruritus and cough Lead Indications Pruritus Associated with Prurigo Nodularis (PN) - PRISM 730k patients WW, 300k in U.S. wi
Slide 6: Broad Applications for Mechanism of Action of HADUVIO
Broad Applications for Mechanism of Action of HADUVIO™
Slide 7: HADUVIO Acts by Rebalancing Kappa and Mu Pathways
Normal State Imbalanced State Pruritic or Cough Induction of Itch/Cough Too little KOR activation and/or too much MOR activation HADUVIO Rebalancing Suppression of Itch/Cough Dual action as both a KOR agonist and a MOR antagonist MOR KOR Ligands MOR Activation KOR Deactivation MOR Antagonist KOR Ago
Slide 8: HADUVIO Showed Durable Results in Itch Across Multiple Studies
HADUVIO™ Showed Durable Results in Itch Across Multiple Studies and Endpoints Over 400 subjects studied with moderate to severe pruritus 1 p=0.017* n=120 p=0.007** n=61 Baseline Score Weeks n= Baseline Score Weeks n= n=20 p=0.028 n=12 p=0.083 n=18 n=22 *All p-values compare treatment group to placeb
Slide 9: HADUVIO is Advancing Two Lead Clinical Programs with Near-Term Readouts
Phase 1 2 3 Filed Pruritus in PN Phase 1 2 3 Filed Chronic Cough in IPF UK reopened after covid restrictions and sites are screening and enrolling Data expected in 1H 2022 ~80% enrolled as of July 2021 Enrollment completion expected – 2H 2021 FDA Fast Track designation granted for moderate to severe
Slide 10: Attractive Categories for Lead Indications
Attractive Categories for Lead Indications 1Iking A JEADV 2013 2Vaidya DC & Schwartz RA Acta Derm Croat 2008 3Trevi data on file 4Voice of the Patient – IPF Patient-focused Drug Development Initiative, 2015 Pruritus Associated with Prurigo Nodularis Chronic Cough in Idiopathic Pulmonary Fibrosis No
Slide 11: Global Potential in Categories Totaling $30B
Global Pruritus Category $20B1 PN $3B2 Global Chronic Cough Category $10B3 IPF $4B4 Prurigo Nodularis (PN) 300,000 U.S. patients 730,000 patients Globally Idiopathic Pulmonary Fibrosis (IPF) 130,000 U.S. patients 1M+ patients Globally HADUVIOTM Global Potential in Categories Totaling $30B 12026 est.
Slide 12: Chronic Pruritus in Prurigo Nodularis
Chronic Pruritus in Prurigo Nodularis
Slide 13: Opportunity to be the First and Only Oral Therapy Approved in PN
Opportunity to be the First and Only Oral Therapy Approved in Pruritus Associated with Prurigo Nodularis 1Huang AH JID 2020 2Stander S JAAD 2020 3Iking A JEADV 2013 4Pereira M JEADV 2018 5Prurigo Nodularis - Market Insights, Epidemiology and Market Forecast 6Eigelshoven CME Derm 2009 7Vaidya DC & Sc
Slide 14: Results from Ph2 Prurigo Nodularis Trial and OLE
Results from Ph2 Prurigo Nodularis Trial and Open Label Extension (OLE) Continued Separation of WI-NRS Over Time Dose Response Supporting 162mg Selection† Drug Separation vs. PBO (OLE) HADUVIOTM Showed Disease Improvements PN Ph2a 50% Responder Analysis (N=63) WI-NRS (Blinded 10 weeks) n=20 p=0.028
Slide 15: Prurigo Nodularis Phase 2 Trial Adverse Events
Avg. Weekly Number of Adverse Events Titration Period Week 1 - 2 3 – 4 7 - 8 9 – 10 8 out of the 10 treatment discontinuations in the HADUVIO™ arms occurred during the initial two week titration period Placebo (N=22) HADUVIO™ ER 81 mg (N=22) HADUVIO™ ER 162 mg (N=18) GRADE 1 2 1 2 3 1 2 Dizziness 1
Slide 16: Phase 2b/3 PRISM Trial Design
Phase 2b/3 PRISM Trial Design (N=360) Trial to Complete Enrollment in 2H 2021 Optimizations from Ph2 to Ph2b/3 PRISM Trial Increased Powering Enriched Population Increased Duration 63 patients (Ph2) → 360 patients (Ph2b/3) Focusing on severe population WI-NRS ≥5 (Ph2) → WI-NRS ≥7 (Ph2b/3) 10 weeks (
Slide 17: Patient Images from PRISM
Patient Images from PRISM Baseline Week 14 Week 52 Baseline Week 14 Week 28 HADUVIO 162mg BID or Placebo HADUVIO 162mg BID
Slide 18: Market Opportunity Across a Broad Array of Chronic Pruritic Conditions
20261 Multiple Sclerosis HIV Protease Inhibitor Induced Pruritus Post Herpetic Pruritus Hepatitis C Chemotherapy Induced Pruritus Burn Induced Pruritus Aquagenic Pruritus Chronic Cirrhosis Cancer Related Pruritus Brachioradial Pruritus Atopic Dermatitis Lichen Simplex Chronicus Psoriasis Primary Scl
Slide 19: Expansion Strategy in Pruritus
Move earlier in the course of the disease where severe chronic itch is present: High severity of pruritus Chronic condition with high unmet need Neurologically mediated condition Expansion Strategy in Pruritus Prurigo Nodularis Complete Uremic Pruritus Development Additional Derm Indication Establis
Slide 20: Otezla Shows the Potential for a Safe and Effective Oral Option
Otezla Shows the Potential for a Safe and Effective Oral Option Otezla launched in 2014 in moderate-severe plaque psoriasis Both Otezla and HADUVIO are oral therapies and require titration to maintenance dose with twice a day dosing Despite an established biologic market, Otezla captured +25% share
Slide 21: Chronic Cough in Idiopathic Pulmonary Fibrosis
Chronic Cough in Idiopathic Pulmonary Fibrosis
Slide 22: Opportunity to be First in Class for Chronic Cough in IPF
70% to 85% of IPF patients are reported to suffer from chronic cough4 Cough is one of the most bothersome symptoms of IPF5 ≥75% of IPF patients report cough as being one of their most significant symptoms Current IPF therapies (anti-fibrotics), which have not been shown to reverse disease progressio
Slide 23: 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 prevented sufentanil-induced cough during anesthesia induction2 Nalbuphine ER has the
Slide 24: Chronic Cough in IPF Phase 2a Trial
2 Double-Blind Crossover Treatment Periods Each Followed by a Washout Period Patient screening activity has resumed at multiple sites in the UK Working to re-open all remaining sites Shelter in place restrictions lifted at the end of March Primary endpoint Mean percent change in daytime cough freque
Slide 25: Market Opportunity Across a Broad Array of Chronic Cough Conditions
20271 COPD Emphysema Refractory Chronic Cough Chronic Bronchitis GERD Heart Failure Idiopathic Non-specific Interstitial Pneumonia Bronchiectasis Hyper-sensitivity Pneumonitis Asthma Lung Cancer Idiopathic Pulmonary Fibrosis Unclassified Idiopathic Interstitial Pneumonia Autoimmune Interstitial Lung
Slide 26: Expansion Strategy in Chronic Cough
Idiopathic Pulmonary Fibrosis Interstitial Lung Diseases Refractory Chronic Cough/ Unexplained Chronic Cough Establish cough efficacy and safety in worst chronic cough condition Expand to other progressing, fibrotic interstitial lung diseases High cough severity Non-productive cough Similar etiology
Slide 27: Investment Highlights
Investment Highlights HADUVIO™ (nalbuphine ER) is an investigational drug 12026 est. Global Pruritus Therapeutics Market Prurigo 22031 est. Prurigo Nodularis Market Report May 2020 32027 est. The Insight Partners Jun 2020 42028 est. Research Idiopathic Pulmonary Fibrosis Report Feb 2021 Attractive M
Slide 28: Thank You
Thank You trevi THERAPEUTICS
Trevi Therapeutics — Investor Presentation (July 2021) on 6ix