According to a story from Market Screener, the drug developer Reviva Pharmaceuticals, Inc. recently announced that it has completed a recent meeting with officials from the US Food and Drug Administration (FDA). This meeting was focused on the company’s Investigational New Drug (IND) application for the company’s product candidate brilaroxazine. This drug is being developed as a treatment for the rare lung disease idiopathic pulmonary fibrosis.
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.
Developing Brilaroxazine for Idiopathic Pulmonary Fibrosis
Recently, the FDA has also awarded Orphan Drug Designation to brilaroxazine as a treatment for idiopathic pulmonary fibrosis. These pre-IND meetings serve as a method for consultation between the agency and the company about the future of the drug’s development. The drug has completed phase 1 clinical testing and with the completion of this meeting, the beginning of the phase 2 trial is expected to be announced relatively soon.
Brilaroxazine is an experimental drug that is designed to interact with the signaling pathways of serotonin. Dysfunctions of serotonin signaling are suspected to play a role in the disease mechanisms of pulmonary arterial hypertension and idiopathic pulmonary fibrosis, as well as some other neurological diseases. This mechanism gives the drug the potential for a diverse array of applications; it has also completed a phase 2 study that showed positive results for acute schizophrenia.