FDA Clears Phase 2 Trial for Possible Idiopathic Pulmonary Fibrosis Drug

According to a story from BioPortfolio, the biopharmaceutical company Genkyotex has recently announced that the US Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application. This approval will allow the testing of the company’s lead experimental product candidate GKT831 as a possible treatment for the rare lung disease idiopathic pulmonary fibrosis. The drug is also being tested in other scarring diseases of the kidney and liver.

About Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis is a deadly, chronic, progressive lung disease which is characterized by lung tissue scarring, leading to a decline in lung function over time. The cause of idiopathic pulmonary fibrosis is unknown. With that being said, there are a few risk factors that have been identified, such as smoking cigarettes, exposure to various dusts (metal, wood, stone, and coal dust), occupations related to farming, family history, and potentially certain viral infections. Symptoms include shortness of breath, a dry cough, a distinctive crackling sound detected with a stethoscope, oxygen deficiency in the blood, and clubbed digits. There are few treatment options that can have a significant impact on the progression of idiopathic pulmonary fibrosis. Treatment may include certain medications, pulmonary rehabilitation, oxygen therapy, and lung transplant. Early intervention can make a major difference in outcomes; five year survival rate is between 20 and 40 percent. To learn more about idiopathic pulmonary fibrosis, click here.

About The Clinical Trial

GKT831 has previously been found to provide anti-inflammatory and anti-scarring benefits in patients with the rare liver disease primary biliary cholangitis. The idiopathic pulmonary fibrosis clinical trial is expected to occur over a 24 week period and will include 60 patients. Patients that receive the drug will receive a 400mg dose twice per day, a dosing level that had proved effective and safe in the prior primary biliary cholangitis trial. The primary endpoint in this study will be changes in the levels of o,o -dityrosine; secondary endpoints will include forced vital capacity, CT imaging results, and the six minute walk test. 

Idiopathic pulmonary fibrosis is currently a disease that is ultimately lethal for everyone who gets it. A successful trial with GKT831 could give patients a new treatment option that provides prolonged survival or perhaps even halts disease progression.


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