Canada NewsWire
BURLINGTON, ON, May 15, 2022
BURLINGTON, ON, May 15, 2022 /CNW/ - Today, Boehringer Ingelheim (Canada) Ltd. announced Phase II data for BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, that was published in The New England Journal of Medicine (NEJM). The promising 12-week data that showed a reduction in the rate of lung function decline in patients with idiopathic pulmonary fibrosis (IPF) will also be presented at the American Thoracic Society (ATS) International Conference Breaking News session on May 16 in San Francisco.1
"These encouraging, early data showed that treatment with BI 1015550 slowed the rate of lung function decline in patients who were not on approved antifibrotics, as well as those who were taking existing antifibrotic therapy," commented Luca Richeldi, Professor of Respiratory Medicine at the Università Cattolica del Sacro Cuore in Rome, Italy, and the Principal Investigator on the trial.
The primary endpoint of the trial was the change from baseline in forced vital capacity (FVC) – meaning the maximum amount of air (measured in mL) that can be forcibly exhaled from the lungs after fully inhaling – at week 12. Median changes for patients taking BI 1015550 showed a slight improvement in FVC, and in those who took placebo, FVC was reduced:1
"As the global market leader in pulmonary fibrosis, we have the ambition to go beyond slowing down disease progression and hope to one day provide a cure for this chronic debilitating condition," said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. "The phase II results reinforce our confidence in BI 1015550 which will be accelerated into a pivotal phase III program. We will work with regulatory agencies and scientific communities to potentially bring the next generation of treatments to people living with pulmonary fibrosis as quickly as possible."
The trial also met its secondary endpoint,1 demonstrating that BI 1015550 showed acceptable safety and tolerability in IPF patients over 12 weeks. Diarrhea was the most frequently reported event in all patients (>10% of patients) and all events were reported as non-serious. No new safety topics were identified, and baseline characteristics were generally balanced across both treatment groups.
BI 1015550 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in February 2022. Boehringer Ingelheim will be initiating a Phase III clinical trial program to further investigate if BI 1015550 improves lung function in people with IPF and other forms of PPF, with the ambition to bring this medicine to patients as soon as possible.
Idiopathic pulmonary fibrosis (IPF) is one of the more common forms of progressive pulmonary fibrosis.2 Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness.3 Although considered "rare," IPF affects approximately 3 million people worldwide.4,5 The disease primarily affects patients over the age of 50 and affects more men than women.2
There are more than 200 lung disorders that can lead to pulmonary fibrosis6 – an irreversible scarring of lung tissue that negatively impacts lung function, quality of life and may become life-threatening.
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at www.boehringer-ingelheim.ca.
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1 Richeldi L., et al. Safety and Efficacy of BI 1015550, a Preferential Inhibitor of Phosphodiesterase 4B, in Patients with Idiopathic Pulmonary Fibrosis: a Phase 2 Trial. Presented at American Thoracic Society (ATS) International Conference Breaking News session on May 16 2022. | |
2 Pulmonary Fibrosis Types and Causes. American Lung Association. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-fibrosis/introduction/types-causes-and-risk-factors. [Accessed May 2022]. | |
3 Symptoms. Pulmonary Fibrosis Foundation. https://www.pulmonaryfibrosis.org/understanding-pff/about-pulmonary-fibrosis/symptoms. [Accessed May 2022]. | |
4 Nalysnyk L., et al. Incidence and Prevalence of Idiopathic Pulmonary Fibrosis: Review of the Literature. Eur Respir Rev. 2012;21(126):355-361. | |
5 Data on file. Boehringer Ingelheim. DOF OFEV.RES.IPF/08/11January2016. Worldwide Prevalence 2016. | |
6 Other Types of Pulmonary Fibrosis. Pulmonary Fibrosis Foundation. https://www.pulmonaryfibrosis.org/understanding-pff/types-of-pulmonary-fibrosis/other-types-of-pulmonary-fibrosis. [Accessed May 2022]. |
SOURCE Boehringer Ingelheim (Canada) Ltd.
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