Trevi Therapeutics, Inc. · NASDAQ:TRVI
Trevi Therapeutics — Investor Presentation (September 2022)
41 slides from Trevi Therapeutics's investor presentation, Sep 19, 2022
Slide 1: Corporate Presentation September 2022
Corporate Presentation September 2022
Slide 2: Forward Looking Statement Disclaimer
Forward Looking Statement 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 19
Slide 3: Developing a First-In-Class Oral Therapy for Hard to Treat Chronic Cough and Pruritic Conditions
Trevi Therapeutics: Developing a First-In-Class Oral Therapy for Hard to Treat Chronic Cough and Pruritic Conditions 3 Trial achieved statistical significance on the primary and all key secondary endpoints Statistically significant for the primary efficacy endpoint measured by a 4-point reduction in
Slide 4: Broad Applications for Mechanism of Action of Haduvio (nalbuphine ER)
Broad Applications for Mechanism of Action of Haduvio™ (nalbuphine ER) 4 Haduvio has a novel mechanism of action acting through the mu and kappa receptors, both peripherally and centrally in the body Mechanism of Action: mu antagonist + kappa agonist Dynamic interchange between the two receptors Cen
Slide 5: Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)
Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)
Slide 6: Prevalence and The Significant Role of Chronic Cough in IPF
Prevalence and The Significant Role of Chronic Cough in IPF 6 1Datamonitor 2015 Idiopathic Pulmonary Fibrosis Disease Coverage Ref Code: DMKC12770 2Nalysnyk L et al. Eur Resp Rev 2012 DOI: 10.1183/09059180.00002512 3Key AL et al. Cough 2010 DOI: 10.1186/1745-9974-6-4 4VanManen M et al. Am J Respir C
Slide 7: CANAL Phase 2 Trial Design
CANAL Phase 2 Trial Design Randomized, Double-Blind, Placebo-Controlled, Two Treatment Period Crossover 7 Randomization Treatment Period 1 nalbuphine ER BID (Day 1 – Day 22) Placebo (Day 1 – Day 22) 2-week washout period / treatment crossover nalbuphine ER BID (Day 1 – Day 22) Placebo (Day 1 – Day 2
Slide 8: CANAL Endpoints
Mean change in daytime cough frequency (coughs per hour) from baseline as assessed by objective digital cough monitoring at Day 22 by treatment. Relative change in daytime cough frequency (coughs per hour) from baseline at Day 22 by treatment. Relative change in 24-hour (combined daytime and nightti
Slide 9: Baseline Characteristics
9 Baseline Characteristics Haduvio (nalbuphine ER) is an investigational drug
Slide 10: Patient Disposition
Screened N=56 Randomized / Enrolled N=42 Completers N=28 (14) Screen Failed (25%) (6) Adverse event (14.6%) (2) Withdrawal by subject (4.9%) (2) COVID-19 pandemic restrictions (4.9%) Patient Disposition 10 Full Analysis Set (FAS) N=38 (1) Protocol deviation (2.4%) (1) Withdrawal by subject (2.4%) (1
Slide 11: Primary Endpoint Achieved Statistically Significant Reduction in Daytime Cough Frequency with Haduvio
11 Primary Endpoint Achieved Statistically Significant Reduction in Daytime Cough Frequency with Haduvio Primary Endpoint calculated as geometric mean percent change in daytime cough frequency from study baseline No sequence or period effect Haduvio (nalbuphine ER) is an investigational drug 75.1% R
Slide 12: Reduction of Cough Frequency Consistent Between Daytime and 24Hr
12 Reduction of Cough Frequency And Placebo-Adjusted Change Were Consistent Between Daytime and 24Hr Cough Frequency 50.8% PBO Adj Chg. 52.5% PBO Adj Chg. Daytime Cough *p<0.0001 * * Endpoint calculated as geometric mean percent change in daytime and 24Hr cough frequency from study baseline No seque
Slide 13: Post-Hoc Responder Analyses
13 Post-Hoc Responder Analyses Clear Separation Between Haduvio vs. Placebo at All Thresholds 1Nguyen AM et al. J Allergy and Clin Immunol 2019 doi.org/10.1016/j.jaci.2018.12.519 Endpoint calculated as geometric mean percent change in 24Hr cough frequency from study baseline Haduvio (nalbuphine ER)
Slide 14: Patient and Clinician Reported Outcomes Support Objective Cough Monitor Results
14 Patient and Clinician Reported Outcomes Support the Results Seen in the Objective Cough Monitor on the Full Dataset (N=38) EXACT2, EXACT7-11, and CS-NRS endpoints calculated as geometric mean percent change from baseline. CGI-C calculated as percent of subjects seeing improvement/decline vs. stud
Slide 15: Haduvio Effect Consistent Independent of Background Anti-Fibrotic Therapy
15 Magnitude of Haduvio Effect Remained Consistent Independent of Background Anti-Fibrotic Therapy Endpoint calculated as geometric mean change in daytime and 24Hr cough frequency from study baseline Haduvio (nalbuphine ER) is an investigational drug
Slide 16: Summary of Treatment-Emergent Adverse Events
Summary of Treatment-Emergent Adverse Events Safety Population 16 Haduvio (nalbuphine ER) is an investigational drug
Slide 17: Treatment-Emergent Adverse Events by CTCAE Grade
Summary of Treatment-Emergent Adverse Events by CTCAE Grade Safety Population1 17 1 One subject may have multiple Adverse Events Summary of Treatment-Emergent Adverse Events by CTCAE Grade - Safety Population Haduvio (nalbuphine ER) is an investigational drug
Slide 18: Chronic Cough in IPF – Anticipated Next Steps
*Trial design is subject to ongoing discussions with the FDA and sufficient funding Haduvio (nalbuphine ER) is an investigational drug Phase 2b Clinical Trial Design* The trial is expected to be a dose-ranging, parallel arm design trial with four arms (three active dose arms and a placebo arm) The t
Slide 19: Chronic Pruritus in Prurigo Nodularis
Chronic Pruritus in Prurigo Nodularis
Slide 20: Market and Competitive Landscape in Prurigo Nodularis
Prevalence United States1-4: 300,000 Worldwide5: 730,000 Treatment Goals5 Reduce pruritus Interrupt the itch-scratch cycle Completely heal PN lesions Current Treatments Currently, no treatments are approved specifically for PN, and available treatments demonstrate variable success 20 Market and Comp
Slide 21: PRISM Phase 2b/3 Trial Design
Haduvio Placebo Haduvio 162 mg BID Placebo BID Open-Label Haduvio 162 mg BID 21 PRISM Phase 2b/3 Trial Design (N=353) Screening Period Blinded Titration Period (2 weeks) Double-Blind Fixed Dose Comparison (12 weeks) Open Label Extension (up to 38 weeks) Primary Endpoint PRISM Trial Design Randomizat
Slide 22: Baseline Characteristics (mITT)
22 Baseline Characteristics (mITT) Haduvio (nalbuphine ER) is an investigational drug
Slide 23: Primary and Key Secondary Endpoint Scales
23 Primary and Key Secondary Endpoint Scales Proportion of subjects with a 4-point reduction from baseline (responders) How would you rate your most severe itching over the past 24 hours? 0 = No Itch 10 = Worst Imaginable Itch Worst Itch NRS (WI-NRS) How often during the past week do these statement
Slide 24: Patient Disposition
Randomized, n=353 Patient Disposition 24 nalbuphine ER, n=173 Placebo, n=180 Randomized but not dosed N=5 (2.9%) mITT, n=168 Randomized but not dosed N=4 (2.2%) mITT, n=176 Discontinuations, n=62 (36.9%) Subjects completing double-blind period, n=106 (63.1%) Discontinuations, n=34 (19.3%) Subjects c
Slide 25: Statistically Significant Results on Primary Efficacy Endpoint in Prurigo Nodularis
Statistically significant reduction in primary endpoint at week 14 (p=0.0157) Efficacy subgroup analyses consistent with the primary endpoint results when evaluating age (≥40 years), gender, or geography (US, EU) Haduvio is the first and only oral therapy to achieve primary endpoint in treating prur
Slide 26: Haduvio Separated From Placebo as Early as Week 6
Proportion of responders with a 4-point reduction from baseline in Worst Itch Numerical Rating Scale (WI-NRS) was statistically significant as early as week 6 (p=0.003) Pruritus reduction and the percent of 4-point responders continued to increase over time An open label extension trial is ongoing H
Slide 27: Significant Effect Across All Key Secondary Endpoints
27 Significant Effect Observed Across All Key Secondary Endpoints (ItchyQoL, PAS-5a, PROMIS) and the Potential to Modify the Underlying Disease *p<0.05 **p<0.01 ***p<0.001 Improvement in sleep disturbances observed as early as week 6 Improvement in overall quality of life and in each of three domain
Slide 28: Improvement in Investigator Global Assessment Observed
Significant proportion of subjects achieved a 1-category improvement in IGA from baseline Responder is defined as a subject who has at a least 1-category improvement in the respective score of IGA-PN activity from baseline 28 Improvement in the Investigator Global Assessment (IGA) Observed, Reducing
Slide 29: Haduvio Subject in the PRISM Trial
29 Haduvio Subject in the PRISM Trial Actual Haduvio patient. Individual results may vary. Source: Data on file, Trevi Therapeutics, Inc. Haduvio (nalbuphine ER) is an investigational drug
Slide 30: Summary of Treatment-Emergent Adverse Events
Summary of Treatment-Emergent Adverse Events Safety Population 30 Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or later Haduvio (nalbuphine ER) is an investigational drug
Slide 31: Treatment-Emergent Adverse Events by CTCAE Grade
Summary of Treatment-Emergent Adverse Events by CTCAE Grade Safety Population1 31 1 One subject may have multiple Adverse Events Summary of Treatment-Emergent Adverse Events by CTCAE Grade - Safety Population Haduvio (nalbuphine ER) is an investigational drug
Slide 32: Clinical Development Anticipated Next Steps For Prurigo Nodularis
Complete open-label extension (last patient last visit – expected for Jan 2023) Present open-label extension data at medical congresses/publication Anticipate End of Phase 2 meeting with FDA (1Q 2023) Plan to initiate Phase 3 Prurigo Nodularis trial (1H 2023) 32 Clinical Development Anticipated Next
Slide 33: Three Layers of Patent Protection for Haduvio for PN and Cough
Expiry 2026-2029 2032-2039 2041 Three Layers of Patent Protection for Haduvio for PN and Cough Potential to Provide Protection Up to 2029 - 2041 Formulation Patents Method of Use Patents Special Population Patents (dependent on label integration) 33 6 issued US patents 4 foreign patents, including t
Slide 34: Trevi's Go Forward Development Strategy
34 Trevi’s Go Forward Development Strategy Goal: Leverage Haduvio’s novel MOA and oral advantage in a focused way to maximize value with our resources Chronic Cough Strategy: Prioritize IPF chronic cough while maintaining optionality with additional chronic cough indications Prurigo Nodularis Strate
Slide 35: Appendix - Market Research
Appendix - Market Research 35
Slide 36: Market Research Supports Favorable Access and Rapid Adoption for Haduvio
Payers Providers N=285 Pulmonologists US Physician Background Market Research Supports Favorable Access and Rapid Adoption for Haduvio Target Product Profile in the Treatment of Chronic Cough in IPF 160.5 million commercial lives 23.2 million Medicare Part D lives 10.0 million Managed Medicaid lives
Slide 37: Efficacy and Safety are Potential Primary Value Drivers for Payers
Efficacy and Safety are Potential Primary Value Drivers for Payers In a New Entrant for Treating Chronic Cough in IPF Not Valuable Very Valuable Payers perceive the main strengths of Haduvio’s target product profile as the reduction in cough frequency measured using VitaloJAK®, safety, and its oral
Slide 38: Providers Recognize the Unmet Need in Chronic Cough in IPF
Providers Recognize the Unmet Need in Chronic Cough in IPF and the Role Haduvio May Fill Based on the Target Product Profile Expected peak prescribing of Haduvio for chronic cough in IPF (No payer access restrictions/nominal copay) Unmet need of IPF Chronic Cough Impact of IPF Chronic Cough on Quali
Slide 39: Physicians Anticipate Use of Haduvio to Peak ~2 Years From Availability
(N=100) Physicians anticipate their use of Haduvio to peak ~2 years from product availability based on target product profile Avg. % of IPF patients with chronic cough expected to be prescribed Haduvio… % of patients Physicians Report they Would Expect a Rapid Uptake with a Short Time to Peak Prescr
Slide 40: Physicians Perceive Very High Unmet Need in Treating Chronic Cough
40 Physicians Interviewed Perceive Very High Unmet Need in Treating Chronic Cough Across Multiple Cough Conditions Bottom 3 boxes (1, 2, 3) Middle 4 boxes (4, 5, 6, 7) Top 3 boxes (8, 9, 10) % of physicians 4 5 No unmet need at all Very high unmet need 1 2 6 3 7 8 9 10 Mean General Pulmonologists be
Slide 41: Physicians Anticipate Their Use of Haduvio to Peak ~2 Years After Launch
41 Physicians Anticipate Their Use of Haduvio to Peak ~2 years After Launch Based on the Target Product Profile Avg. % Non-IPF PF-ILD and RCC/UCC patients with chronic cough expected to be prescribed Haduvio… % of patients Source: Market research interviews and quantitative study with US pulmonologi
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