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

By Vandana Singh4 days ago

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  • Results from a sub-analysis of patients with diabetes mellitus from Phase 3 SONICS study evaluating Strongbridge Biopharma plc's (NASDAQ: 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.
  • Price Action: SBBP shares are up 2.57% at $2.79 during premarket hours on the last check Thursday.

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