Boehringer Ingelheim has announced that its drug nintedanib, already sold under various brand names such as Ofev and Vargatef, has met its primary endpoint in the SENSCIS trial.
The drug was found to achieve reduction in the annual rate of decline in forced vital capacity (FVC, an established measure of lung function) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).
Nintedanib slowed lung function decline by 44% compared to placebo, marking the first time a targeted therapy designed to address the underlying process of the disease (lung fibrosis) has been shown to slow down lung function in SSC-ILD in a clinical trial.
The findings are “extremely important”, said Professor Toby Maher, SENSCIS steering committee member, “particularly given that there are currently no approved treatments for this condition, which disproportionately affects women, and especially those between 25 and 55 years old.
“A 44% reduction in lung function decline represents a significant slowdown in the development of irreversible fibrosis of the lung. Nintedanib has the potential to make a big difference to the lives of people with this rare, life-shortening disease.”
The FDA recently granted priority review for nintedanib in SSc-ILD, and the trial results formed the basis of the application for regulatory approval of nintedanib in SSc-ILD that was filed with the FDA and EMA by Boehringer Ingelheim in March 2019.
Approximately 19,390 people live with scleroderma in the UK, a rare autoimmune disease which can cause thickening and scarring of connective tissue throughout the body and impacts four times as many women as men. 80% of people with scleroderma (SSc) will develop interstitial lung disease (ILD), the leading cause of mortality in people living with scleroderma.
SSC-ILD is a rare, life-shortening disease with no current approved treatments.