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.
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.
About Cushing’s Syndrome
About the SONICS Study
(1) Dose Titration Phase: Patients started RECORLEV at 150 mg twice daily (300 mg total daily dose) and titrated in 150 mg increments with the goal of achieving a therapeutic dose – a dose resulting in mUFC normalization – at which point titration was stopped; (2) Maintenance Phase: The dose was fixed and should not have been changed other than for safety reasons or loss of efficacy. At the end of the six-month maintenance phase, the mUFC response rate was measured; and (3) Extended Evaluation Phase: Patients continued on RECORLEV for another six months to evaluate long-term safety and tolerability and explore efficacy durability.
RECORLEV has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.
About Strongbridge Biopharma
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