Pulmonary Fibrosis News – Orphan Drug Status Sought for NP-120 to Treat IPF With Cough
Algernon Pharmaceuticals has filed for orphan drug status for NP-120 (ifenprodil), an experimental oral medicine for patients with idiopathic pulmonary fibrosis (IPF) who have persistent, hard-to-treat cough.
“The FDA has a standard response time of 90 days to requests for orphan designation, and so we should know by the end of the year whether it has been granted,” Christopher Bryan, PhD, Algernon’s vice president of Research and Operations, said in an emailed statement to Pulmonary Fibrosis News.
Bryan noted that, “in parallel to the orphan request,” Algernon will file a pre-investigational new drug application (IND) “in order to confirm details of the company’s plan to begin a larger multinational Phase 2 study in IPF next year.” An IND is a formal request therapy developers make to regulators to ask permission to initiate a clinical trial.
The filing with the U.S. Food and Drug Administration (FDA) came after the company got full results from its Phase 2a clinical trial (NCT04318704) where NP-120 was found to be safe and well tolerated to ease cough and maintain lung function in IPF patients.