>
  1. How to use GuruFocus - Tutorials
  2. What Is in the GuruFocus Premium Membership?
  3. A DIY Guide on How to Invest Using Guru Strategies
Business Wire
Business Wire
Articles 

PT010 Significantly Reduced Rate of Moderate or Severe COPD Exacerbations in Phase III ETHOS Trial

June 24, 2020 | About:


Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).





Compared with glycopyrronium/formoterol fumarate, PT010 achieved a 24% reduction (p<0.001) in exacerbations. PT010 achieved a 13% reduction (p=0.003) compared with PT009 (budesonide/formoterol fumarate). The dual-combination therapies used as comparators in the trial represent recommended therapeutic classes for the treatment of COPD.





In a key secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate (unadjusted p=0.01).





The results were published in the [url="]%3Ci%3ENew+England+Journal+of+Medicine%3C%2Fi%3E[/url] and simultaneously presented at the American Thoracic Society virtual Scientific Symposium, Clinical Trial Results in Pulmonary Medicine. AstraZeneca will continue to review these data with health authorities.





Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and Lead Investigator of the ETHOS trial, said: “The Phase III ETHOS trial results are important and demonstrate the benefit of PT010 in reducing the rate of exacerbations in this progressive disease. The findings also show that reducing risk of all-cause mortality is achievable and could transform treatment goals in chronic obstructive pulmonary disease.”





Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Chronic obstructive pulmonary disease is the third leading cause of death worldwide and exacerbations can contribute to an increase in mortality in these patients. The results of the Phase III ETHOS trial support the strong clinical profile of PT010 in reducing exacerbation rates compared with dual-combination therapies. We are excited to have the data on all-cause mortality, which is a key consideration for COPD management.”





The safety and tolerability of PT010 were consistent with the known profiles of the dual comparators. In the trial, the most frequently reported adverse events were nasopharyngitis, COPD and upper respiratory tract infection. The incidence of confirmed pneumonia was 4.2% with PT010, 2.3% with glycopyrronium/formoterol fumarate and 4.5% with PT009.





These results are based on PT010 at the standard dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg), an inhaled corticosteroid (ICS). In the trial, PT010 at half the dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 160/14.4/9.6mcg) also demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with glycopyrronium/formoterol fumarate (14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg).





PT010 is approved in [url="]Japan[/url] and [url="]China[/url] for patients with COPD. It is also under regulatory review in the US and EU.





COPD





COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people and is the third leading cause of death globally. Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD. Even a single COPD exacerbation may be associated with a significant increase in the rate of decline in lung function, a significant deterioration in quality of life, and can significantly reduce life expectancy and increase the risk of mortality.





ETHOS and the ATHENA clinical trial program





ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations.





Glycopyrronium/formoterol fumarate is a fixed-dose dual bronchodilator in a pressurized metered-dose inhaler (pMDI), combining glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA). PT009 is a single inhaler, fixed-dose dual-combination therapy of budesonide, an ICS, and formoterol fumarate, a LABA. It was developed as a relevant comparator in clinical trials for PT010.





ETHOS involved more than 8,500 patients who had experienced ≥1 moderate/severe exacerbation in the previous year and were receiving at least two inhaled maintenance treatments at entry into the trial.





ETHOS is part of AstraZeneca’s ATHENA Phase III clinical trial program for PT010, which included more than 15,500 patients globally across 11 trials. The results of the earlier pivotal Phase III KRONOS trial were published in [url="]%3Ci%3ELancet+Respiratory+Medicine%3C%2Fi%3E[/url].





ETHOS Primary and Key Secondary Endpoints





ETHOS Primary Endpoints



Endpoint



Timepoint



Comparison/results



Rate of moderate


or severe COPD


exacerbations









Over 52 weeks









PT010 (320mcg budesonide dose) vsglycopyrronium/formoterol fumarate



Significant (p<0.001)



PT010(320mcg budesonide dose) vs PT009



Significant (p=0.003)



PT010(160mcg budesonide dose) vs glycopyrronium/formoterol fumarate



Significant (p<0.001)



PT010 (160mcg budesonide dose) vs PT009



Significant (p=0.002)





ETHOS Secondary Endpoints



Endpoint



Timepoint



Comparison/results



Time to first


moderate or


severe COPD


exacerbation



Over 52 weeks



PT010 (320mcg budesonide dose) vs glycopyrronium/formoterol fumarate



Significant (p=0.004)



PT010 (320mcg budesonide dose) vs PT009



Significant (p=0.006)



PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate



Significant (p=0.001)



PT010 (160mcg budesonide dose) vs PT009



Significant (p=0.002)



Rate of severe


COPD


exacerbations



Over 52 weeks



PT010 (320mcg budesonide dose) vsglycopyrronium/formoterol fumarate



Not significant (p=0.09)



PT010 (320mcg budesonide dose) vs PT009



Significant (p=0.02)



PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate



Not significant (p=0.22)



PT010 (160mcg budesonide dose) vs PT009



Not significant (p=0.06)



Time to death (all-


cause mortality)



Over 52 weeks



PT010 (320mcg budesonide dose) vs glycopyrronium/formoterol fumarate



Nominally Significant (unadjusted p=0.01)



PT010(320mcg budesonide dose) vs PT009



Not significant (p=0.34)



PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate



Not significant (p=0.27)



PT010 (160mcg budesonide dose) vs PT009



Not significant (p=0.59)





PT010





PT010 (budesonide/glycopyrronium/formoterol fumarate) is a single-inhaler, fixed dose triple-combination of budesonide, an ICS, with glycopyrronium, a LAMA, and formoterol fumarate, a LABA.





Under the terms of the agreement to acquire Pearl Therapeutics Inc., AstraZeneca anticipates making a $150m milestone payment upon US regulatory approval of PT010 for COPD. This payment would be the final development and regulatory milestone under that agreement.





AstraZeneca in Respiratory & Immunology





Respiratory & Immunology is one of AstraZeneca’s three therapy areas and is a key growth driver for the Company.





AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.





With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including Systemic Lupus Erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.





AstraZeneca





AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit [url="]www.astrazeneca-us.com[/url] and follow the Company on Twitter [url="]%40AstraZenecaUS[/url].





US-40366 Last Updated 6/20

View source version on businesswire.com: https://www.businesswire.com/news/home/20200624005784/en/


Rating: 0.0/5 (0 votes)

Comments

Please leave your comment:



Performances of the stocks mentioned by Business Wire


User Generated Screeners


pjmason14Momentum
wigbertHigh FCF-M2
kosalmmuse6
kosalmmuseBest one1
DBrizanall 2019Feb26
kosalmmuseBest one
DBrizanall 2019Feb25
kosalmmuseNice
kosalmmusehan
MsDale*52-Week Low
Get WordPress Plugins for easy affiliate links on Stock Tickers and Guru Names | Earn affiliate commissions by embedding GuruFocus Charts
GuruFocus Affiliate Program: Earn up to $400 per referral. ( Learn More)