On February 17th, 2023 , Pulmongene Ltd. announced that the company’s investigational drug PMG1015 has been granted Orphan Drug Designation (ODD) for the indication of Idiopathic Pulmonary Fibrosis (IPF).
The FDA’s orphan drug designation supports the development of medicines intended to treat rare diseases that affect fewer than 200,000 people in the United States. Products that receive this designation are eligible for various incentives in the U.S., including tax credits and seven years of market exclusivity after approval. Additionally, the FDA provides regulatory guidance and support to expedite drug development and review processes.
“We are pleased that PMG1015 has been granted Orphan Drug Designation by the FDA. This represents the FDA’s full recognition of Pulmongene’s first-in-class drug candidate and its novel mechanism for treating IPF,” said Dr. Nan Tang, the founder of the Pulmongene. “The ODD designation for PMG1015 will also help accelerate its clinical development in the United States and provide a new therapeutic option for IPF patients worldwide who currently need effective treatment options.”
IPF is a progressive lung fibrotic disease and the most common type of interstitial lung disease. The median survival time after diagnosis is 2-4 years, with 80% of patients dying within 5 years of diagnosis. It has an insidious onset and progressively worsens. Symptoms include progressive deterioration of lung function, breathing difficulties, and decreased exercise tolerance, severely impacting patients’ quality of life. The incidence of IPF is continuously rising globally. According to IPF Foundation, the incidence rate has doubled over the past decade. It is estimated that approximately 50,000 people die from IPF annually in the United States, exceeding the death toll of most cancers, including breast cancer.
To date, the FDA has only approved two drugs for treating IPF: Pirfenidone and Nintedanib. While these two drugs can slow down the decline in lung function, they have severe side effects, often leading to reduction in dosage or discontinuation of treatment altogether.
About Pulmongene
Pulmongene Ltd. is dedicated to developing innovative first-in-class drugs for the treatment of lung diseases and organ fibrosis. The company currently has multiple first-in-class pipeline products in both clinical and preclinical stages. With its top-tier scientific research capabilities, Pulmongene strives to translate solid scientific discoveries into effective novel therapeutic solutions.