Corbus Pharmaceuticals reported today that the Phase 2b clinical trial of its potential anti-inflammatory drug lenabasum did not meet its primary objective of decreasing pulmonary exacerbations in people with cystic fibrosis.
Reducing the frequency of pulmonary exacerbations was the primary goal, or endpoint, of the 28-week study. People who took the drug during the trial did not experience a reduction in the rate of new exacerbations compared to those who took a placebo.
“We are disappointed with the results of the study,” said J.P. Clancy, MD, vice president of clinical research at the Cystic Fibrosis Foundation. “We recognize that people with cystic fibrosis need additional treatment options to reduce the frequency of pulmonary exacerbations, and that this is particularly true for individuals who do not yet have a therapy approved for their underlying mutation. The CF Foundation remains committed to pursuing new research in inflammation that could lead to new treatments.”
Corbus indicated that they plan to provide additional details of the study results during a poster presentation at the North American Cystic Fibrosis Conference.
Although inflammation in the lungs is typically triggered by an infection, recent studies suggest that people with CF have chronic inflammation even when there is not an active infection. Chronic inflammation causes damage to lung tissue that can eventually lead to respiratory failure.
Current options to fight inflammation in CF are limited to high-dose ibuprofen, which is not widely used for extended periods of time due to potential side effects, such as abdominal pain and gastrointestinal bleeding.
For more information about the trial results, see the Corbus press release.
Despite the approval of new treatments for the underlying cause of CF, many people with CF will continue to need treatments for complications such as inflammation. The CF Foundation is dedicated to funding research into potential treatments for complications of CF, investing $65 million in 2019.