A robust, prospective, multinational clinical trial program included a second phase 3 study1

Study design1

The SONICS study evaluated the efficacy and safety of Recorlev® in patients with Cushing’s syndrome in a multicenter, open-label study consisting of 3 phases.

  • At baseline, the mean (SD) of the mUFC was 243 µg/24h (269), which corresponds to approximately 5xULN
  • SONICS included Recorlev treatment-naïve patients with persistent or recurrent disease despite surgery, previously medically treated patients, and previously untreated patients
A robust, prospective, multinational clinical trial program included a second phase 3 study

Key limitations of the SONICS study are the open-label design and absence of a control group.

Proven reduction of cortisol in the supportive SONICS study1

Primary endpoint

Complete response rate: The proportion of patients with normalization of mUFC at the end of the maintenance phase without an increase in dose at any time during 6 months

By the end of dose titration at week 21, 67% of patients achieved mUFC normalization. By the end of the 6-month maintenance phase, 31% achieved normalization without a dose increase; 78% achieved normalization or a 50% reduction in mUFC regardless of dose increase. By the end of the extended evaluation phase, 17% achieved normalized mUFC without a dose increase.
By the end of dose titration at week 21, 67% of patients achieved mUFC normalization. By the end of the 6-month maintenance phase, 31% achieved normalization without a dose increase; 78% achieved normalization or a 50% reduction in mUFC regardless of dose increase. By the end of the extended evaluation phase, 17% achieved normalized mUFC without a dose increase.

because 51% of the patients discontinued treatment prematurely due to adverse reaction, lack of efficacy, or other reasons, these results should be interpreted with caution.

  • *Data based on 55 maintenance phase completers with both baseline and month 6 mUFC data available.2

BID=twice daily; mUFC=mean urinary free cortisol; ULN=upper limit of normal.

References: 1. Recorlev [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc 2. Fleseriu M, Pivonello R, Elenkova A, et al. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing’s syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial [published correction appears in Lancet Diabetes Endocrinol. 2019;7(11):e22]. Lancet Diabetes Endocrinol. 2019;7(11):855-865. 3. Fleseriu M, Auchus RJ, Greenman Y. Levoketoconazole treatment in endogenous Cushing’s syndrome: extended evaluation of clinical, biochemical, and radiologic outcomes. Eur J Endocrinol. 2022;187(6):859-871.

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