Strongbridge Biopharma announced new data analyses from a phase 3 study of Recorlev (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome. Related secondary endpoints were presented at the 16th Annual International Pituitary Congress (IPC) while a subgroup analysis was presented at the ENDO meeting.

Levoketoconazole, a ketoconazole stereoisomer, is a steroidogenesis inhibitor being developed for the treatment of endogenous Cushing’s syndrome, a rare disease characterized by overproduction of cortisol. The SONICS study was an open-label study (N=94) that evaluated Recorlev for endogenous Cushing’s syndrome. The study consisted of a dose titration phase, a maintenance phase, and an extended evaluation phase.

At ENDO, researchers reported that mean urinary-free cortisol (mUFC) normalization with Recorlev was similar in patients with and without diabetes. In the maintenance phase, HbA1c and fasting blood glucose improvements were “more pronounced” among patients with comorbid diabetes mellitus; the use of antidiabetic medications was reduced more often than increased. In addition, there were significant improvements in cardiovascular risk markers of LDL, weight, BMI, and waist circumference in patients with and without diabetes mellitus; LDL improvement was seen without initiating any new statins or increases in statin dose.

At IPC, researchers reported sustained reductions in both mUFC and late night salivary cortisol (LNSC) levels over a 6-month maintenance treatment period with Recorlev. Levels of adrenocorticotrophic hormone hormone in a subset of patients with Cushing’s disease doubled from baseline to the end of the maintenance phase.

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“The subgroup analysis of Cushing’s syndrome patients with diabetes mellitus – among the more common comorbidities associated with the disease – not only shows similar levels of cortisol control compared to patients without, but also more pronounced improvements in key glycemia measures, such as hemoglobin A1c and fasting blood glucose, and other cardiovascular risk markers, such as LDL-cholesterol. In both treatment groups, the overall safety profile was acceptable,” stated Maria Fleseriu, MD, FACE, professor of Medicine and Neurological Surgery and director of the Oregon Health Sciences University Northwest Pituitary Center, who presented the data.

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