Adams Respiratory Therapeutics Inc
Adams Respiratory Therapeutics — Technical Presentation (April 2007)
25 slides from Adams Respiratory Therapeutics's technical presentation, Apr 4, 2007
Slide 1: Erdosteine: Where Are We Today?
Erdosteine: Where Are We Today? Helmut Albrecht, MD Senior Vice President, R&D April 4, 2007
Slide 2: Safe Harbor
Safe Harbor This presentation contains certain "forward-looking" statements. These statements are based on the current estimates and assumptions of the management of Adams Respiratory Therapeutics, Inc. ("Adams") as of the date of this presentation and are subject to uncertainty and changes in circu
Slide 3: Preliminary Results of Phase IIb Study
Preliminary Results of Phase IIb Study Subsequent analyses are showing more promising data, but it is too early to draw conclusions March 16, 2007 Disclosure "The preliminary data suggest a significant placebo effect and that the two different erdosteine treatment groups do not seem to break statist
Slide 4: COPD: Fastest Growing US Health Problem
COPD: Fastest Growing US Health Problem 7
Slide 5: COPD: A Chronic Progressive Disease
COPD: A Chronic Progressive Disease 9 Celli et al: ATS/ERS Task Force. Eu Respir J. 2004; 23:932-46
Slide 6: COPD: Recommended Progression of Pharmacotherapy
COPD: Recommended Progression of Pharmacotherapy I: Mild II: Moderate III: Severe IV: Very Severe Add Short-acting Bronchodilator Add Long-acting Bronchodilators and Rehabilitation Add ICS* if repeated exacerbations > Add long-term oxygen indicated > Consider surgical treatments What's missing? *Inh
Slide 7: Erdosteine: A Muco-Regulator
Erdosteine: A Muco-Regulator Mode of Action: Cleaves disulfide links found in mucus proteins Pharmacologic Effects: Thins mucus and alters flow characteristics (reduces viscosity, elasticity, and adhesiveness) Improves mucociliary clearance Reduces mucus volume Reduces cough and dyspnea Additional P
Slide 8: Equalife Study: Recent Published Erdosteine Data From Europe
Equalife Study: Recent Published Erdosteine Data From Europe (completed between 2000 and 2002) Outcomes Erdosteine 300mg, b.i.d. (n = 63) Placebo (n = 61) p-value Patients with exacerbation 37 (58%) 48 (77%) NS Exacerbation/pt 0.94 (1.12) 1.38 (1.39) <0.05 Admissions/pt 0.16 (0.57) 0.31 (0.74) <0.05
Slide 9: Erdosteine Phase IIb Clinical Study
Erdosteine Phase IIb Clinical Study Objective: LifeShirt(r) Subjective: SGRQ BCSS LCQ VAS Cough Frequency Health Status Subjective: SGRQ Objective: 6MWT FEV-1 LifeShirt(r) # of Acute Exacerbations Physician & Patient Global Assessments {PSGA/SSGA} General Safety & AE Evaluation Model as discussed wi
Slide 10: Life Shirt
Life Shirt Life Shirt Go ahead, make my day!
Slide 11: Phase IIb Clinical Study Protocol
Phase IIb Clinical Study Protocol Study Design Randomized, double-blind, parallel-group, multi-center, placebo-controlled dose-ranging study Doses Tested 150 mg, 300mg or matching placebo capsules, b.i.d. Objectives Test 2 dose levels vs. placebo Exploratory Phase IIb study Evaluate 10+ primary & se
Slide 12: Statistical Analysis
Statistical Analysis Intent-To-Treat (ITT), Per Protocol (PP) analyses completed per Statistical Analysis Plan Additional analyses ongoing Population subsets, sub-domains Additional statistical methods Co-medications Comparing effects between visits, etc. Source: Adams' U.S. Phase IIb Erdosteine cli
Slide 13: Physician Global Assessment
Physician Global Assessment (PSGA, per protocol) (PSGA, per protocol) (PSGA, per protocol) p= 0.0142 Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 14: BCSS Total Score
BCSS Total Score (mean, per protocol) (mean, per protocol) (mean, per protocol) p=0.193 (300mg bid vs. placebo at wk 12) Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 15: BCSS Sputum Score
BCSS Sputum Score (mean, per protocol) (mean, per protocol) (mean, per protocol) p=0.159 (300mg bid vs. placebo at wk 12) Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 16: BCSS Cough Score
BCSS Cough Score (mean, per protocol) (mean, per protocol) (mean, per protocol) p=0.225 (300mg bid vs. placebo at wk 12) p=0.180 (300mg bid vs. placebo at wk 16) Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 17: Sicker Patients Improve on High-Dose Erdosteine in LCQ Subset Analysis
Sicker Patients Improve on High-Dose Erdosteine in LCQ Subset Analysis p=0.0038 p=0.0087 Analysis showing the difference between weeks 4 and 12 of treatment Source: Adams' U.S. Phase IIb Erdosteine clinical trial. 33
Slide 18: Leicester Cough Questionnaire Physical Score
Leister Cough Questionnaire Physical Score (mean, per protocol) Physical Score (mean, per protocol) Physical Score (mean, per protocol) ? Overall p= 0.12 ? 150mg bid vs Pl, p=0.045 ? 300mg bid vs Pl, p=0.144 Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 19: Saint George's Respiratory Questionnaire (SGRQ) Impact Score
Saint George's Respiratory Questionnaire (SGRQ) Impact Score (mean, per protocol) (SGRQ) Impact Score (mean, per protocol) (SGRQ) Impact Score (mean, per protocol) p=0.39 (150 bid vs. Pl.); p=0.57 (300mg bid vs. Pl) Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 20: LifeShirt Results
LifeShirt(r) Results Small sample size: 87 (78 = 22/21/35) Mixed results across variables Some with no change/difference from placebo Some parameters show positive trends Several statistically significant results, e.g. Accelerometer (activity measure): p=0.041/0.043 Cough Frequency (overall): p=0.01
Slide 21: LifeShirt Accelerometer: Activity Results
LifeShirt(r) Accelerometer: Activity Results (ITT, mean data-Clinic) (ITT, mean data-Clinic) (ITT, mean data-Clinic) (ITT, mean data-Clinic) p=0.041, 300mg bid vs Pl at wk 12 Source: Adams' U.S. Phase IIb Erdosteine clinical trial.
Slide 22: Summary of Safety Data
Summary of Safety Data Safety data collected in daily diary No problematic safety issues or surprise results 1 fatality (cardiovascular-related) 22 serious adverse events (SAE's) 638 AEs total (~ 1.5 AEs/patient in 12 weeks) No apparent safety issues with co-medications
Slide 23: Key Outcomes To Date Phase IIb Erdosteine Study
Key Outcomes To Date Phase IIb Erdosteine Study Most of the primary and secondary outcome variables are without significant results vs. placebo Positive Outcomes To Date Statistically significant Physician's Global Assessment and positive trends for the BCSS (overall drug effect) Improving role of s
Slide 24: Where Are We Today?
Where Are We Today? While subsequent analyses are showing more promising data, it is still too early to determine ultimate outcome Continue 'data mining' during Q4, FY 07 Review results, trends and hypotheses with external experts Formulate potential follow-on research plans in FY08, if warranted Di
Slide 25: Glossary for Outcome Variables
Glossary for Outcome Variables 6MWT: 6-minute walk test BCSS: Breathlessness, cough, and sputum scale FEV1: 1-second forced expiratory volume LCQ: Leicester cough questionnaire PSGA: Physician static global assessment SGRQ: St George's respiratory questionnaire SSGA: Subject static global assessment
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