New Phase III study of nintedanib in people with systemic sclerosis and lung fibrosis

After demonstrating that nintedanib slows disease progression in idiopathic pulmonary fibrosis, Boehringer Ingelheim is expanding its research with nintedanib into other serious fibrotic lung conditions that arise in association with rare diseases such as systemic sclerosis.
Boehringer Ingelheim has announced that the first person has been enrolled in the SENSCIS (Safety and Efficacy of Nintedanib in Systemic SClerosIS) study. The global Phase III trial, which is now open for recruitment, is investigating the efficacy and safety of nintedanib in people with a rare disease called systemic sclerosis (SSc) who also developed interstitial lung disease (SSc-ILD) (NCT02597933). In total, 520 people are expected to be enrolled in clinical trial centres worldwide.
Systemic sclerosis, also known as scleroderma, is a rare disease characterised by the thickening and scarring of connective tissue of multiple organs in the body. The scarring can also affect the lungs and when this occurs the condition is called SSc-ILD.2 The presence of ILD with SSc often indicates a poor prognosis and higher risk of death.
“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. “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.”
It is estimated that SSc-ILD affects up to 86,000 people in the U.S. and 200,000 people in Europe, making it an orphan, or rare disease. Worldwide, it is estimated that approximately two million people have SSc, and up to 90% may develop some degree of ILD.
“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,” said Ann Kennedy, 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.”
Related News
-
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience. -
News How GLP-1 agonists are reshaping drug delivery innovations
GLP-1 agonist drug products like Ozempic, Wegovy, and Mounjaro have taken the healthcare industry by storm in recent years. Originally conceived as treatment for Type 2 diabetes, the weight-loss effects of these products have taken on unprecedented int... -
News A Day in the Life of a Start-Up Founder and CEO
At CPHI we work to support Start-Up companies in the pharmaceutical industry and recognise the expertise and innovative angles they bring to the field. Through our Start-Up Programme we have gotten to know some of these leaders, and in this Day in the ... -
News Biopharmaceutical manufacturing boost part of new UK government budget
In their national budget announced by the UK Labour Party, biopharmaceutical production and manufacturing are set to receive a significant boost in capital grants through the Life Sciences Innovative Manufacturing Fund (LSIMF). -
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva.
Recently Visited
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance