Burlington, Ontario, May 27, 2019 – Results from a pivotal Phase III SENSCIS® trial met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Interstitial lung disease (ILD) is a key driver of mortality in people living with systemic sclerosis (SSc) – also known as scleroderma – and the absence of treatment options constitutes a high unmet need.
Results show that nintedanib slows the loss of pulmonary function in patients with SSc-ILD compared to placebo. Patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured in FVC assessed over 52 weeks. These new data were published in the New England Journal of Medicine (NEJM) and presented simultaneously to the medical community at the American Thoracic Society (ATS) International Conference on May 20th in Dallas.