Germany-based Boehringer Ingelheim announced that its SENSCIS Phase III clinical trial met its primary endpoint, which was reduction in the annual rate of decline in forced vital capacity (FVCa). The trial evaluated the company’s nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The drug slowed the loss of pulmonary function in the patients compared to placebo. The cohort receiving nintedanib showed a 44% decrease in the rate of decline of their lung function measured in FVC over 52 weeks.
Nintedanib is currently approved in more than 70 countries for idiopathic pulmonary fibrosis (IPF). In the SENSCIS trial, 576 patients in more than 32 countries were assessed over 52 weeks. It is an intracellular tyrosine kinase inhibitor and is marketed under the brand names Ofev and Vargatef.
Systemic sclerosis is also called scleroderma. It is a rare incurable autoimmune disease that affects connective tissue. The disease can cause scarring, or fibrosis, of the skin in addition to major organs such as the heart, lungs, digestive tract and kidneys. It can have life-threatening complications. About 25% of patients develop pulmonary involvement within three years of being diagnosed. When it affects the lungs, it can cause interstitial lung disease (ILD, known as SSc-ILD. It accounts for about one-third of deaths in the disease. There are currently no approved treatments for SSc-ILD.
“The SENSCIS results provide positive news for people living with SSc-ILD and their physicians because currently there are no approved treatments,” stated Oliver Distler, Professor of Rheumatology, University Hospital Zurich and lead investigator of the trial. “A 44% reduction in lung function decline indicates a significant slowdown in disease progression. Nintedanib could make a considerable difference to the lives of people with this rare and often life-threatening disease.”
The data was used to build a regulatory application with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the first quarter of this year. The FDA granted it Priority Review status.
In the trial, patients were randomized 1:1 to receive either 150 mg twice-daily oral nintedanib or placebo. Key secondary endpoints were overall changes in modified Rodnan skin score and St. George’s Respiratory Questionnaire (SGRQ) from baseline at week 52.
Of the 576 patients in the trial, 51.9% had diffuse cutaneous systemic sclerosis and 48.8% were receiving mycophenolate at baseline. The adjusted annual rate of FVC change was -52.4 ml per year for patients receiving nintedanib, a reduced rate compared to the -93.3 ml average change in the placebo cohort. The Modified Rodnan skin score and total SGRQ score from baseline to week 52 didn’t change significantly in the treatment groups.
The researchers wrote, “Despite the large variability associated with the adjusted annual rates of decline in FVC observed in the current trial and the limitations inherent in comparing groups of patients who had not undergone randomization according to mycophenolate use, these data suggest a potential benefit of mycophenolate on lung function.”