Phase III LINC-4 study of Isturisa for the treatment of patients with Cushing’s disease.- Recordati

Recordati announces positive results from the large Phase III LINC-4 study of Isturisa (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Data from the LINC-4 study demonstrate that a significantly higher proportion of patients receiving Isturisa achieve normal mUFC, the primary treatment goal for Cushing’s disease, after 12 weeks of treatment versus placebo (77% vs 8%; P<0.0001). Improvements in mUFC levels are sustained over 36 weeks of treatment(81% of patients). Isturisa is well tolerated and has a manageable safety profile, with the most common adverse events in LINC-4 being arthralgia, decreased appetite, fatigue, and nausea.

The findings from LINC-4, the first Phase III study of a medical therapy in Cushing’s disease to contain an upfront placebo-controlled phase, builds on existing clinical evidence and affirms the effectiveness of Isturisa in this hard-to-treat
patient population.

Isturisa has recently received marketing authorization in the European Union (January 2020) and United States (March 2020) for the treatment of Cushing’s syndrome and Cushing’s disease, respectively.