Strongbridge's Recorlev Shows Improvements in Cortisol Control In Cushing's Syndrome, Diabetes

Results from a sub-analysis of patients with diabetes mellitus from Phase 3 SONICS study evaluating Strongbridge Biopharma plc's SBBP Recorlev (levoketoconazole) for endogenous Cushing's syndrome were published in Frontiers in Endocrinology.
Treatment with Recorlev resulted in significant cortisol control and meaningful improvements in key glycemic measures, such as hemoglobin A1c and fasting blood glucose, and cardiovascular risk markers such as low-density lipoprotein (LDL)-cholesterol.
The results were observed following a dose-titration phase and a six-month maintenance phase.
Mean urinary-free cortisol normalization rate was similar in patients with and without diabetes at the end of the maintenance phase.
Mean improvements in HbA1c and FBG in the maintenance phase were more meaningful among patients with comorbid diabetes mellitus than those without.
Adverse events that were more common in patients with diabetes mellitus included nausea (58.3%), vomiting (19.4%), and urinary tract infection (16.7%); none prompted study drug withdrawal.
Endogenous Cushing's syndrome is a rare endocrine disease caused by chronic elevated cortisol exposure, often resulting from a benign tumor of the pituitary gland.
Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor.
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