Methods and Compositions for Treating Idiopathic Pulmonary Fibrosis

Abstract

Provided is a pharmaceutical composition comprising an effective amount of itraconazole, and a pharmaceutically acceptable excipient. The use of the pharmaceutical composition for treatment of idiopathic pulmonary fibrosis is also provided.

Description

BACKGROUND OF THE INVENTION[0001]Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive lung disease that results in respiratory failure and death. IPF is the most common cause of death from progressive lung disease, and affects about 5 million people worldwide. An estimated median survival after diagnosis is only 2-3 years (Chakraborty et al., (2014) Expert Opin Investig Drugs, 23:893-910; Spagnolo et al., (2015) Pharmacology &Therapeutics 152:18-27; Tzouvelekis et al., (2015) Therapeutics and Clinical Risk Management 11:359-370). In the United States, as many as 89,000 people are afflicted with IPF, with about 34,000 newly diagnosed annually (Raghu G et al., (2006) Am J Respir Crit Care Med 174: (7):810-816). Prevalence of IPF ranges from 14.0 to 42.7 cases per 100,000 persons and the annual incidence ranges from 6.8 to 16.3 cases per 100,000 persons, depending on the strictness of the diagnostic criteria employed (Raghu G et al., supra.). The prevalence of IPF increases...

AI Technical Summary

Benefits of technology

By using a proper dosage and taking it through a new route, we discovered that itraconazole can successfully work to prevent or treat IPF.

Problems solved by technology

Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive lung disease that results in respiratory failure and death.

As interstitial fibrosis advances with accompanying distortion of lung architecture, the lung becomes less compliant, increasing the effort associated with breathing, leading to dyspnea.

Typically, lung function declines slowly over time, but some patients experience rapid declines that can lead to hospitalization or death, particularly in later stages of the disease.

Development of agents for treatment of IPF has been slow in progress.

These two agents, however, have only limited efficacy and significant side effects, and require complicated dosing regimen.

), but most IPF patients are not eligible for transplantation because of their age or comorbid conditions.

However, in U.S. Patent Publication No. 20170362211, the same group of researchers pointed out that, even though itraconazole may have efficacy in both bleomycin-induced lung and carbon tetrachloride-induced liver fibrosis mouse models, the drug's use as an anti-fibrotic is limited due to known adverse effects, such as P450 inhibition.

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