Boehringer Ingelheim announced the first patient enrolled in its Phase II clinical trial BALANCE-CF™ 1 to evaluate a new treatment for cystic fibrosis. The trial will investigate how different doses of the compound, an inhaled epithelial sodium channel (ENaC) inhibitor, impacts lung function compared to placebo when added to the standard of care in adults and adolescents with cystic fibrosis.
People with cystic fibrosis have a genetic mutation that causes mucus in various organs to become thick and sticky. In the lungs, thick and sticky mucus clogs the airways and traps germs, like bacteria, leading to infections, inflammation, respiratory failure and other complications. 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.
The BI ENaC inhibitor is intended to treat patients with all types of cystic fibrosis mutations. It is delivered via the Respimat® inhaler, which is the platform inhaler of Boehringer Ingelheim. The Respimat® inhaler delivers medicine in a slow-moving mist that helps patients inhale the medicine. People with cystic fibrosis often have a high treatment burden, sometimes spending hours administrating multiple treatments. The Respimat inhaler is portable and delivers the BI ENaC inhibitor in puffs.
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"We are pleased to enroll 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, which among other symptoms, can cause persistent lung infections and limits the ability to breathe over time. Despite improved treatment options in recent years, patients still face deteriorating health and have a median life expectancy in their 40s.