October 16, 2019
Boehringer Ingelheim today announced the first patient enrolled in its Phase II clinical trial BALANCE-CFTM 1 to evaluate a new potential treatment for cystic fibrosis.1,2 The trial will investigate how different doses of the compound, an inhaled epithelial sodium channel (ENaC) inhibitor, impact lung function compared to placebo when added to the standard of care in adults and adolescents with cystic fibrosis.1,3,4
People with cystic fibrosis have genetic mutations that cause mucus in various organs to become thick and sticky.5 In the lungs, thick and sticky mucus clogs the airways and traps germs, like bacteria, leading to infections, inflammation, respiratory failure and other complications.6 The inhaled ENaC inhibitor (BI 1265162) is designed to block the absorption of sodium that may keep the surface of the airways hydrated, which may help make mucus less thick, making it easier to keep airways clear in cystic fibrosis.7,8
The ENaC inhibitor is intended to treat patients with all types of cystic fibrosis mutations.1,9 It is inhaled via the Respimat®1, which is the platform inhaler of Boehringer Ingelheim. The Respimat® inhaler actively delivers medicine in a slow-moving soft mist that is easy to inhale even for people who have difficulty breathing.10,11 People with cystic fibrosis often have a high treatment burden, sometimes spending hours administrating multiple treatments.12 The BI 1265162 ENaC inhibitor is delivered via the Respimat®1 to offer a quick inhalation that can be taken anywhere and is intended to be added to the standard of care.
“We are pleased to enrol our first patient into this Phase II trial, and we hope our ENaC inhibitor will be proven to help people affected by cystic fibrosis,” said Dr Kay Tetzlaff, Head of Medicine, Therapeutic Area Inflammation, Boehringer Ingelheim. “Boehringer Ingelheim is committed to researching new treatments that address serious unmet needs. We are hopeful that this treatment, along with its delivery method, will make an important difference for patients affected by this debilitating condition.”
Cystic fibrosis is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time.6 Despite improved treatment options in recent years, patients still face deteriorating health and have a median life expectancy in their 40s.12
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For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/cystic-fibrosis-phase-ii-trial