Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Technical Presentation (June 2021)
16 slides from Theravance Biopharma's technical presentation, Jun 21, 2021
Slide 1: Nezulcitinib (TD-0903) Phase 2 Top-line Results
Nezulcitinib (TD - 0903) Phase 2 Top - line Results Inhaled lung - selective pan - JAK inhibitor to treat: Acute lung injury due to COVID - 19 June 21, 2021 THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance
Slide 2: Forward-looking statements
Forward - looking statements 2 Under the safe harbor provisions of the U . S . Private Securities Litigation Reform Act of 1995 , the company cautions investors that any forward - looking statements or projections made by the company are subject to risks and uncertainties that may cause actual resul
Slide 3: Nezulcitinib: an inhaled, lung-selective pan-JAK inhibitor in development
-9 -8 -7 -6 -5 -4 0 2 4 6 8 Log(Compound(M)) F o l d C h a n g e Vehicle % I n h i b i t i o n 0.1 1 10 0.1 1 10 0 20 40 60 80 100 120 Nezulcitinib Dexamethasone Nezulcitinib: an inhaled, lung - selective pan - JAK inhibitor in development ‣ Suppresses release of key inflammatory markers associated
Slide 4: Nezulcitinib: randomized, double-blind, placebo-controlled Ph 2 study in severe COVID-19
Nezulcitinib: randomized, double - blind, placebo - controlled Ph 2 study in hospitalized patients with severe COVID - 19 with impaired oxygenation *Loading dose (double the standard dose) administered on Day 1. NCT04402866 IMV, invasive mechanical ventilation; PK, pharmacokinetics; SARS - CoV - 2,
Slide 5: Nezulcitinib Phase 2 COVID-19 trial summary
Nezulcitinib Phase 2 COVID - 19 trial summary ‣ Efficacy outcomes, n=210 – Primary: No statistically significant difference between nezulcitinib and placebo for RFDs from randomization through Day 28 – Secondary: No difference in change from baseline at Day 7 in SaO 2 /FiO 2 ratio, proportion of pat
Slide 6: Summary of patient disposition (Randomized population)
Summary of patient disposition (Randomized population) AE, adverse event. 6 *24 patients discontinued early from the study: 21 for AEs (19 leading to death), 2 by patient’s choice, and 1 was lost to fo llo w - up after being discharged to a different hospital. n (%) Nezulcitinib n=106 Placebo n=104
Slide 7: Baseline demographics and clinical characteristics
Baseline demographics and clinical characteristics *Two patients without a baseline Clinical Status score (CS). BMI, body mass index; CRP, C - Reactive protein; SD, standard deviation. 7 Nezulcitinib n=106 Placebo n=104 Mean age, years ± SD 58.3 ± 12 .42 58.1 ± 1 2.54 Male, n (%) 65 (61.3%) 63 (60.6
Slide 8: Respiratory failure-free days from randomization to day 28 (ITT)
CI, confidence interval; ITT, intent - to - treat; Q1, 1st quartile; Q3, 3rd quartile; RFD, respiratory failure - free days; SD, stand ard deviation. Common Odds Ratio (nezulcitinib vs placebo) and corresponding 95% Wald CI obtained from proportional odds regression model of RF D adjusting for basel
Slide 9: Nezulcitinib showed a trend of improvement in time to recovery compared to placebo (ITT)
Nezulcitinib showed a trend of improvement in time to recovery compared to placebo (ITT) 1. Kaplan - Meier estimates. 2. Hazard ratio (nezulcitinib vs placebo) and 95% CI calculated from Cox proportional hazards model adjusting for baseline ag e s trata (≤60 vs >60 years). 3. Stratified log - rank p
Slide 10: Nezulcitinib showed a trend of improvement in 28-day all-cause mortality rate and time to mortality (ITT)
Nezulcitinib showed a trend of improvement in 28 - day all - cause mortality rate and time to mortality (ITT) 1. Hazard ratio (nezulcitinib vs placebo) and 95% CI calculated from Cox proportional hazards model adjusting for baseline ag e s trata (≤60 vs >60 years). 2. Unstratified log - rank p - val
Slide 11: CRP and patients hospitalized with COVID-19
CRP and patients hospitalized with COVID - 19 Wang S, et al. Infect Dis 2020;9:2445 - 2453. Nurshad S, J Med Virol . 2020 Jun 9. 1 - 3 Manson J et al. Lancet Rheum 2020; 2: e594 - 604. ALI, acute lung injury; CRP, C - reactive protein. 11 CRP stable CRP elevation Potential for classification of COVI
Slide 12: Nezulcitinib: improvement in time to recovery in patients with baseline CRP <150 mg/L
0 7 14 21 28 0.2 0.0 0.4 0.6 0.8 1.0 Time from Randomization (days) Cumulative Proportion Recovered Nezulcitinib: improvement in time to recovery compared to placebo in patients with baseline CRP <150 mg/L 1. Kaplan - Meier estimates. 2. Hazard ratio (nezulcitinib vs placebo) and 95% CI calculated f
Slide 13: Nezulcitinib: improvement in 28-day all-cause mortality and time to mortality in CRP <150 mg/L
Nezulcitinib: improvement in 28 - day all - cause mortality rate and time to mortality compared to placebo in patients with baseline CRP <150 mg/L 1. Hazard ratio (nezulcitinib vs placebo) and 95% CI calculated from Cox proportional hazards model adjusting for baseline ag e s trata (≤60 vs >60 years
Slide 14: Executive summary of safety results
Executive summary of safety results Safety data based on 205 treated patients. 14 Nezulcitinib n=103 Placebo n=102 Adverse events 34.0% 41.2% Serious adverse events 9.7% 15.7% Liver abnormalities or disease 9.7% 7.8% Serious infections 1.0% 2.0% Venous thromboembolism 0 4.9% ‣ Nezulcitinib was well
Slide 15: Nezulcitinib Phase 2 COVID-19 trial summary
Nezulcitinib Phase 2 COVID - 19 trial summary ‣ Efficacy outcomes, n=210 – Primary: No statistically significant difference between nezulcitinib and placebo for RFDs from randomization through Day 28 – Secondary: No difference in change from baseline at Day 7 in SaO 2 /FiO 2 ratio, proportion of pat
Slide 16: Thank You
Thank You THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third party trademarks used herein are the property of their respective
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