ImmuneRegen BioSciences Inc., a wholly owned subsidiary of IR Biosciences Holdings Inc., has announced the submission of an application for Orphan Drug Product Designation for the company's lead compound, Homspera, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments.
The United States Orphan Drug Act was created in 1983 to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, a waiver of user fees, the potential for grant funding, and tax benefits for clinical trials. Many orphan products receive expedited review or accelerated approval because they are for serious or life-threatening diseases.
Idiopathic Pulmonary Fibrosis is a progressive interstitial lung disease characterized by scarring of lung tissue. Over time, the formation of scars replaces air sacs with fibrotic tissue, preventing the lung from effectively transferring oxygen into the bloodstream. Recent research suggests pulmonary fibrosis may be a reaction to microscopic injury to the lung resulting from the inhalation of pollutants, radiation exposure, and other insults.
ImmuneRegen continues to advance the development of its Homspera drug candidate for the treatment of Idiopathic Pulmonary Fibrosis in collaboration with Dr. Jacob Finkelstein at the University of Rochester and several Contract Research Organizations. "ImmuneRegen is excited to be pursuing the indication of Idiopathic Pulmonary Fibrosis most aggressively, as this disease is still without an effective licensed treatment in the U.S., although many expect InterMune's pirfenidone to eventually be approved. The relative lethality yet low prevalence of IPF confers Orphan Drug Status and Fast Track eligibility for many potential therapeutics, and most analysts believe IPF therapies will have a multi-billion dollar commercial market. Leveraging the support of our industry and academia partners will allow us to expedite the development of Homspera for this indication, and will expand opportunities for more rapid development in the other areas we are and or expect to pursue, such as neutropenia, Influenza and Melanoma," explained ImmuneRegen CEO Michael Wilhelm.