FDA Grants Orphan Designation to Samumed’s IPF Treatment

The FDA granted Samumed an Orphan Drug designation for its SM04646 compound for idiopathic pulmonary fibrosis, a chronic disorder that causes deteriorating lung function.

The drug is administered locally via a nebulizer and has the potential to be used as a monotherapy or in combination with currently approved oral medications, Esbriet (pirfenidone) or Ofev (nintedanib).

Samumed recently completed a Phase I study in healthy subjects, with SM04646 appearing to be safe and well tolerated.