Bronger Ingeham announces that THESCIS ® clinical trials have reached their primary endpoint

, also known as sclerosis, is a rare autoimmune disease that affects connective tissue and cannot be cured. It can cause scarring (fibrosis) of the skin and major organs such as the heart, lungs, digestive tract and kidneys, and can be life-threatening. [2] About 25% of people with supkin disease experience significant lung damage within 3 years of diagnosis.
recently, Grigg Ingham announced that the SENSCIS® clinical trial has reached its primary endpoint: reducing the annual rate of decline in forced lung capacity (FVC) in patients with systemic sclerosis-related interstitiotic pulmonary disease (SSc-ILD).
results showed that Nidanib slowed the decline in lung function in patients with systemic sclerosis-related interstitiotic lung disease (SSc-ILD) compared to placebo. In patients treated with nidanib, the rate of decreased lung function decreased by 44% (based on FVC measured over a 52-week period).
the new data are now published in the New England Journal and presented to the medical community at the 2019 annual meeting of the American Thoracic Science (ATS) in Dallas, USA.
SENSCIS ® was one of the largest randomized controlled trials conducted in patients with systemic sclerosis-related interstitiotic lung disease (SSc-ILD). The results also showed that the safety and toerability characteristics of Nidanib were similar to those observed in patients with idynapathic pulmonary fibrosis (IPF), with the most common adverse event being diarrhea.
has been approved in more than 70 countries (including China) and regions around the world for the treatment of idiolytic pulmonary fibrosis (IPF). These findings form the basis of Bringer Ingham's application to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for registration of Nidanib for the treatment of systemic sclerosis-related interstitiotic lung disease (SSc-ILD) in the first quarter of 2019.
, the FDA granted Nidanib priority review of registration applications for the treatment of SSc-ILD. Submitting these registrations is part of the company's ongoing efforts to improve the survival of patients with pulmonary fibrosis, especially those with rare diseases where demand is far from being met.
SENSCIS® is a Phase III, double-blind, randomized, placebo-controlled trial that included 576 patients (including Chinese patients) in 32 countries and regions. The main endpoint is the annual decrease rate of forced lung capacity (FVC) (ml/year) over a 52-week period. At the end of the 52-week trial, the FVC annual decline rate (ml/year ;p) was -52.4 for patients in the Nidanib treatment group and -93.3 for the placebo group (absolute difference was 41.0 mL/year. This is equivalent to a 44% decrease in lung function, similar to the results of the phase III trial in ® in IF. (Drug Information Network)