Strongbridge Biopharma plc Announces Publication of Diabetes Subgroup Analysis from Phase 3 SONICS Study of RECORLEV (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome in Frontiers in Endocrinology

RECORLEV (levoketoconazole) Treatment Demonstrates Clinically Meaningful Improvements in Cortisol Control and Clinical Benefit in Patients with Cushing’s Syndrome and Comorbid Diabetes Mellitus

DUBLIN, Ireland and TREVOSE, Pa., April 07, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that results from a subanalysis of patients with diabetes mellitus from the Phase 3 SONICS study of RECORLEV (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome were published in the peer-reviewed journal, Frontiers in Endocrinology.

“Diabetes mellitus is among the more common complications related to excess levels of cortisol in people with Cushing’s syndrome,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “The SONICS study results provide important evidence that help further characterize the potential clinical benefit and role of RECORLEV as an important treatment option for patients with Cushing’s syndrome.”

The manuscript, entitled “Levoketoconazole in the Treatment of Patients with Cushing’s Syndrome and Diabetes Mellitus: Phase 3 SONICS Results,” demonstrates that treatment with RECORLEV results in significant cortisol control in patients with Cushing’s syndrome and diabetes mellitus, as well as meaningful improvements in key glycemic measures, such as hemoglobin A1c (HbA1c) and fasting blood glucose (FBG), and cardiovascular risk markers such as low-density lipoprotein (LDL)-cholesterol. These results were observed following a dose titration phase and a six-month maintenance phase.

• Mean urinary-free cortisol (mUFC) 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 in those without. These improvements in glycemia markers were not due to changes in antidiabetic medication use, which were overall stable during treatment.
• Significant mean reductions from baseline, representing improvement in cardiovascular risk markers of LDL-cholesterol, weight, and body mass index were seen in patients with and without diabetes mellitus.
• 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. As noted in the Phase 3 SONICS results published in The Lancet Diabetes & Endocrinology, nausea and headache were the most common adverse events in the overall study population. These events rarely affected treatment and did not appear to be dose related.

These results were previously presented in part at the 2019 Annual Meeting of the Endocrine Society (ENDO), held March 23 – 26, in New Orleans, Louisiana. The poster, entitled Results from the Phase 3 Multicenter SONICS Study of Levoketoconazole: Subgroup Analysis of Cushing’s Syndrome in Patients with Diabetes Mellitus, can be accessed here.