Slide 1: TD-4208 LAMA Phase 2b Study 0117 Results
TD-4208 LAMA Phase 2b Study 0117 Results September 8, 2014
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance Biopharma intends such fo
Slide 3: Positive Top-Line Results in TD-4208 Phase 2b Study 0117
Positive Top-Line Results in TD-4208 Phase 2b Study 0117 Met primary efficacy endpoint at doses of 88 mcg and above Met secondary efficacy endpoints at doses of 88 mcg and above Achieved objective of demonstrating sub-therapeutic dose Demonstrated significant bronchodilation over 24 hours Generally
Slide 4: TD-4208 Phase 2b Dose-Ranging Study Design
Randomized, double-blind, placebo-controlled parallel group study Primary efficacy endpoint: Change from baseline in trough FEV1 following Day 28 dose Multiple secondary efficacy, safety and tolerability endpoints 355 patients with moderate-to-severe COPD TD-4208 Phase 2b Dose-Ranging Study Design R
Slide 5: Population Reflects Moderate-to-Severe COPD Patient Profile
Population Reflects Moderate-to-Severe COPD Patient Profile Characteristics of Patients Enrolled in Study Total (N=355) Mean age (years) 62 Male (%) 50% Current smoker (%) 54% Mean smoking pack-years 52 FEV1 / FVC ratio 0.51 Mean FEV1 (L) 1.3 Mean FEV1 % predicted 44 Not reversible to short-acting b
Slide 6: Primary Endpoint of Change from Baseline in Trough FEV1 Met for Doses of 88 mcg and Above
Primary Endpoint of Change from Baseline in Trough FEV1 Met for Doses of 88 mcg and Above Change from baseline FEV1 44 mcg 88 mcg 175 mcg 350 mcg Difference from placebo (mL) 52 187 167 171 Multiplicity-adjusted p-value 0.141 <0.001 <0.001 <0.001 TD-4208 (mcg) p-values versus placebo: <0.001*** FEV1
Slide 7: Placebo-corrected Spirometry Profiles Show Sustained Bronchodilation over 24 hours
Placebo-corrected Spirometry Profiles on Day 28 Show Sustained Bronchodilation over 24 hours 24-hour Profile Differentiates Effective Doses from Sub-Effective Dose FEV1: forced exploratory volume in one second PD: pre-dose 0 50 100 150 200 250 PD 1 2 3 4 6 8 10 12 15 21 23.75 Time point (hours) Adju
Slide 8: Secondary Endpoints Met for Doses of 88 mcg and Above
Placebo-corrected change from baseline in weighted mean FEV1 (0-24hrs) on Day 28 165, 162 and 174 mL for 88, 175 and 350 mcg respectively (p<0.001) Demonstrates sustained 24-hour duration of action Median time to a 100 mL increase from baseline on Day 1 30 minutes for doses of 88 mcg and above (p<0.
Slide 9: Adverse Event Profile: Generally Well Tolerated
Adverse Event Profile: Generally Well Tolerated Description Placebo (N=71) TD-4208 44 mcg (N=68) TD-4208 88 mcg (N=71) TD-4208 175 mcg (N=71) TD-4208 350 mcg (N=74) Any Adverse Events (AEs) 22 (31.0%) 16 (23.5%) 26 (36.6%) 22 (31.0%) 23 (31.1%) AEs with > 1% frequency: Headache 2 (2.8%) 1 (1.5%) 2 (
Slide 10: Overview of Adverse Event Profile
Overview of Adverse Event Profile Description Placebo (N=71) TD-4208 44 mcg (N=68) TD-4208 88 mcg (N=71) TD-4208 175 mcg (N=71) TD-4208 350 mcg (N=74) Any Adverse Events (AEs) 22 (31.0%) 16 (23.5%) 26 (36.6%) 22 (31.0%) 23 (31.1%) AEs Leading to Discontinuation 1 (1.4%) 1 (1.5%) 1 (1.4%) 5 (7.0%) 4
Slide 11: No Clinically Significant Findings in Other Safety Measures
No clinically significant abnormalities in any laboratory parameters No clinically significant changes in vital signs No clinically significant change in ECG heart rate or QTcF interval No Clinically Significant Findings in Other Safety Measures
Slide 12: TD-4208 Phase 2b Study Summary
TD-4208 Phase 2b Study Summary Met primary and secondary efficacy endpoints at doses of 88 mcg and above Achieved objective of demonstrating sub-therapeutic dose of 44 mcg TD-4208 generally well tolerated TD-4208 demonstrated significant bronchodilation over 24 hours Results demonstrate TD-4208 pote