Redx Orphan Status for Pulmonary Fibrosis

FDA has granted Redx an orphan drug designation for zelasudil (RXC007), an oral, selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor for treating idiopathic pulmonary fibrosis (IPF). Zelasudil is currently in a Phase 2a trial in IPF patients, with topline data expected early next year.

Zelasudil works by targeting ROCK2, which sits at a nodal point in the cell signaling pathway that is believed to be central to fibrosis, the company says. “ROCK2 selectivity is important to avoid systemic hypotension, a serious cardiovascular side effect,which has been seen in product candidates that systemically inhibit both ROCK1 and ROCK2,” it adds.

IPF is a debilitating lung disease that progressively causes scarring and a reduction in lung function. The company says that patients diagnosed with IPF have an estimated life expectancy of three to five years, adding that there is no known cure and current treatment only slows disease progression.