According to Relief Therapeutics, the FDA has granted orphan drug designation for RLF-100 inhaled aviptadil for the treatment of sarcoidosis; RLF-100 is currently in Phase 2 development for that indication. Relief also recently acquired German company AdVita Lifescience, which has been developing inhaled aviptadil for human and veterinary use, with Relief citing the benefits of acquiring AdVita intellectual property related to inhaled aviptadil.
Aviptadil already has Fast Track designation from the FDA for the treatment of COVID-19. Relief is co-developing Zyesami aviptadil for that indication with NRx Pharmaceuticals (formerly NeuroRx), and NRx initiated a Phase 2/3 trial of inhaled Zyesami for the treatment of COVID-19 in February 2021. Earlier this year, Relief and NRx each issued press releases discussing disputes between the companies, including disputes related to funding of that trial. AdVita and Relief have also been partnered on development of inhaled aviptadil for the treatment of COVID-19 and initiated a Phase 2 trial in May 2021.
Relief Chairman of the Board Raghuram Selvaraju commented, “Receipt of our third orphan drug designation is another important milestone for the company, as it underscores the potential strength of our pipeline and the high need for better treatments for rare diseases such as sarcoidosis. The timing of this newest orphan drug designation comes on the heels of our just closed acquisition of AdVita Lifescience GmbH and supplements those we have for our drug candidates for EB and PKU, which we added to our pipeline through our recent acquisition of APR Applied Pharma Research SA, consistent with our strategy to become a fully integrated diversified commercial-stage pharmaceutical company.”
Read the Relief Therapeutics press release on the orphan drug designation.
Read the Relief Therapeutics press release on the acquisition of AdVita.
