Positive results from phase III LINC 4 study reinforce the efficacy and safety of Isturisa in Cushing's disease. -Recordati

Recordati Rare Diseases announces that positive results from the Phase III LINC 4 study of Isturisa were presented on March 22 at the Endocrine Society’s Annual Meeting. Results from LINC 4, the first Phase III study in patients with Cushing’s disease to include an upfront, double-blind, randomised, placebo controlled period, demonstrated that Isturisa provided rapid and sustained normalisation of mean urinary free cortisol (mUFC) levels. Normalising mUFC levels represents an important treatment goal that can potentially reduce , morbidity, improve quality of life and restore the life expectancy of patients with Cushing’s disease towards that of the general population. The Phase III LINC 4 study enrolled adult patients with persistent, recurrent or de novo Cushing’s disease who had mUFC >1.3 x upper limit of normal (ULN). Seventy-three patients received randomised treatment with Isturisa or placebo (2:1) during the initial 12-week, double-blind, placebo controlled period; 48 patients were included in the Isturisa arm and 25 patients in the placebo arm. All patients received open-label Isturisa after week 12 until the end of the core study (week 48). The primary endpoint of the LINC 4 study was met: a significantly higher proportion of patients achieved normal mUFC levels with Isturisa than with placebo at the end of the initial 12-week placebo-controlled phase (77% vs 8%; P<0.0001). median time to first controlled mufc response (mufc less than uln) was 35 days. the key secondary endpoint was also met, with the majority (81%) of patients having normal mufc levels at week 36. the rapid and sustained reductions in mufc levels were accompanied by improvements in cardiovascular and metabolic-related parameters, including systolic and diastolic blood pressure and glycated haemoglobin (hba1c) at both week 12 and the end of the core study. isturisa was well tolerated in linc 4, further supporting the manageable safety profile established in previous studies. the most common adverse events (aes) reported up to data cut-off were arthralgia (45%), decreased appetite (45%), fatigue (38%), nausea (37%) and headache (33%). hypocortisolism related aes were reported in 27% of patients. most hypocortisolism-related aes were of mild or moderate severity, were managed with dose reduction, dose interruption, and or additional therapy, and did not require discontinuation of isturisa treatment.>