SONICS study of Recorlev in Cushing’s syndrome published in European Journal of Endocrinology
Xeris Biopharma announced that the European Journal of Endocrinology (EJE) published the extended evaluation (EE) results of the SONICS study (NCT01838551) evaluating longer-term effects of Recorlev (levoketoconazole) on cortisol levels, biomarkers of Cushing’s syndrome (CS) comorbidities, clinical signs and symptoms of CS, and quality of life. The manuscript also reports findings from pituitary adenoma imaging in the SONICS study
For the first time, the longer-term effects of levoketoconazole are reported from the EE phase of the previously published SONICS study. EE study participants (N=60) received maintenance treatment with levoketoconazole (median exposure for entire study of 15 months, range 7.9-22 months) with assessments scheduled at Month 9 and Month 12. The majority (39/60 [65%]) received levoketoconazole doses of 600 mg/day or less at the start of the EE period. Forty-six (77%) patients completed the study (Month 12).
Sixty patients entered EE at Month 6; 61% (33/54 with data) exhibited normal mean urinary free cortisol (mUFC). At Months 9 and 12, respectively, 55% (27/49) and 41% (18/44) of patients with data had normal mUFC. In addition, reductions in late-night salivary cortisol (LNSC) and random serum cortisol were observed at Month 6, 9, and 12. Mean fasting glucose, total and LDL-cholesterol, body weight, body mass index, abdominal girth, Cushing QoL, and BDI-II scores improved from study baseline at Months 9 and 12. Female patients reported significant mean decreases in hirsutism score at all assessments; mean testosterone levels decreased significantly at Month 6 and were maintained throughout EE period. Of 31 patients with tumor measurements at baseline and Month 12 or follow-up, largest tumor diameter was stable in 27 (87%) patients, decreased in 1, and increased in 3 (largest increase 4 mm). Forty-six patients completed Month 12; 4 (6.7%) discontinued during EE due to adverse events. The most common adverse events in EE were arthralgia, headache, hypokalemia, and QT prolongation (6.7% each). No patient experienced ALT or AST >3x ULN, QTcF interval >460 msec, or adrenal insufficiency during EE.
See: Levoketoconazole treatment in endogenous Cushing’s syndrome: extended evaluation of clinical, biochemical, and radiologic outcomes. Maria Fleseriu et al. European Journal of Endocrinology 01 Oct 2022 https://doi.org/10.1530/EJE-22-0506
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