Samumed’s SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the treatment of ideopathic pulmonary fibrosis.
According to Samumed, SM04646 has the potential for use as either as a combination therapy with oral therapies such as pirfenidone or nintedanib or as a monotherapy.
Samumed Chief Medical Officer Yusuf Yazici commented, “The FDA’s decision to grant an ODD to SM04646 for IPF is another important milestone in the development of SM04646. IPF is a chronic, progressive, fibrotic disorder that causes deteriorating lung function and severe dyspnea in patients and ultimately ends in fatality. Early trials demonstrate the therapeutic potential of SM04646 to help address the unmet medical need of individuals with IPF.”
Read the Samumed press release.
