Strongbridge Biopharma presents new data from SONICS study at IPC, ENDO
Strongbridge Biopharma announced the presentation of new data analyses from the Phase 3 SONICS study of Recorlev for the potential treatment of endogenous Cushing's syndrome. Secondary endpoint results were presented at the International Pituitary Congress, or IPC and a subgroup analysis was presented at the Endocrine Society, or ENDO. Mean urinary-free cortisol, or mUFC, normalization with Recorlev was similar in patients with and without diabetes. Improvements in hemoglobin A1c and fasting blood glucose in the maintenance phase were more pronounced among patients with comorbid diabetes mellitus, while anti-diabetic medications were more often decreased than increased. Significant improvements in cardiovascular risk markers of low-density lipoprotein cholesterol, weight, body mass index and waist circumference were seen in patients with and without diabetes mellitus. Additionally, improvement in LDL-cholesterol occurred without any new use of statins or increases in statin dose. The most common treatment-emergent adverse events in patients with diabetes mellitus were nausea, vomiting and urinary tract infection, headache, peripheral edema and hypertension were most common among patients without diabetes mellitus. Recorlev treatment led to sustained reductions in both mUFC and late night salivary cortisol levels over a six-month maintenance treatment period. Adrenocorticotrophic hormone levels in the subset of patients with Cushing's disease increased about two-fold from baseline to the end of the maintenance phase. Recorlev was generally well-tolerated with no unexpected safety signals observed during the study.