FDA Accepts IND Application for Idiopathic Pulmonary Fibrosis Drug

According to a press release from X-Rx Inc., a privately-held American biotechnology company, the Food and Drug Administration has accepted the company’s Investigational New Drug (IND) application for X-165, an experimental drug for the treatment of idiopathic pulmonary fibrosis.

About Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease characterized by the progressive scarring of lung tissue.

As the word idiopathic implies, there is no known defining cause of IPF. In all likelihood it is rooted in some combination of both genetic and environmental factors. For example, mutations to the TERC and TERT genes are associated with inherited IPF, while smoking or exposure to particulate dust are also thought to contribute to development of the disease.

It affects roughly .02% of the population, with some 100,000 IPF patients living in the U.S. alone. Every year, 30- to 40,000 new cases are diagnosed, mostly affecting those between the ages of 50 and 70.

Eventually, advanced scarring leaves the lungs unable to adequately supply the body with oxygen. Most with IPF survive about three to five years after being diagnosed, though cases can vary in their severity and survivability. Some people with IPF can live upwards of ten years.

About X-165

There isn’t much that’s set in stone about X-165, at the moment.

We know that in its current form, X-165 is an orally-delivered small molecule inhibitor of the enzyme autotaxin. Pre-clinical trials of the drug have yielded encouraging enough data for X-Rx to take it to lab. The biotech company hopes future clinical testing will prove that their drug is effective in slowing the progression of scarring in fibrotic patients.

Medications not yet approved for marketing by the FDA are not normally permitted to cross state lines. Investigational new drug applications are a sort of workaround for pharmaceutical companies that allow manufacturers to distribute testing quantities to trial sites throughout the country. INDs are kind of like the starting line for clinical trials to begin.

X-Rx plans to soon begin a randomized, double-blind, placebo-controlled phase 1 clinical trial to determine the safety of X-165 in humans.

Considering the often serious implications for patients’ quality of life, a breakthrough in IPF research is sorely needed. Currently there is no cure.

Lung diseases are responsible for myriads of deaths in the United States every year. How might research into rare diseases improve the general health of the overall population? Share your thoughts with Patient Worthy!

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