Boehringer Ingelheim announced the enrollment of the first patient in its global, double-blind, randomized and placebo-controlled SENSCIS Phase 3 clinical trial.
The trial (NCT02597933), is open for patient recruitment, and is evaluating the safety and the efficacy of nintedanib (marketed as OFEV for the treatment of IPF) in patients with systemic sclerosis (SSc) who have also developed interstitial lung disease (SSc-ILD). In total, the company is planning to enroll 520 patients in research centers worldwide.
Systemic sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis, including lung fibrosis (interstitial lung disease, ILD), which is one of the main drivers for mortality. There is preclinical evidence for the efficacy of nintedanib (an intracellular inhibitor that targets multiple tyrosine kinases) in SSc and associated ILD, and the anti-fibrotic efficacy of nintedanib has also been demonstrated in idiopathic pulmonary fibrosis patients who are presenting a similar pattern regarding lung fibrosis.
Estimates indicate that SSc-ILD affects some 86,000 people in the United States and 200,000 in Europe, making it a rare disease. Worldwide, estimates indicate that about two million people have SSc, and up to 90% may develop some degree of ILD.
“People affected by SSc-ILD are often young, between 25 and 55 years old, and are faced with considerable disability related to the systemic nature of scleroderma. They often have significant shortness of breath and cough from lung disease, and severe pain and contractures as a consequence of their skin involvement. This occurs during years when they are deeply engaged in building careers and caring for family,” said Kristin Highland, MD of the Cleveland Clinic Foundation, in a recent press release. “There are no approved treatments for SSc-ILD, and few drugs have been assessed in clinical trials for this disease. The SENSCIS™ trial will help to further inform the medical community about SSc-ILD and whether nintedanib could be an effective therapy for people with this condition.”
“The patient community has been waiting for approved treatments for systemic sclerosis patients who have developed the critical complication of interstitial lung disease, and it welcomes Boehringer Ingelheim’s research conducted in this disease area,” added Ann Kennedy with the Federation of European Scleroderma Associations (FESCA aisbl).
“Nintedanib, which is marketed as OFEV, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, we are evaluating whether nintedanib can have a beneficial impact on lung fibrosis associated with SSc,” said Dr. William Mezzanotte, Therapeutic Area head, Respiratory Medicine at Boehringer Ingelheim. “The SENSCIS study is another milestone in our ongoing commitment to furthering science that addresses the unmet needs of people affected by rare diseases and serious respiratory conditions, including fibrotic lung diseases.”
The trial is expected to conclude in May 2018.