Xeris Biopharma Holdings, Inc. announced it is presenting new data on the burden of illness in Cushing's syndrome (CS) and the double-blind, placebo-controlled LOGICS study of Recorlev®(levoketoconazole) in CS during the Pituitary Disorders/Neuroendocrinology ePoster sessions at the American Association of Clinical Endocrinology (AACE) Annual Meeting, May 12-14, 2022. LOGICS, a phase 3 double-blind, placebo-controlled randomized-withdrawal (RW) study evaluated the drug-specificity of cortisol normalization in adults with CS by comparing the effect of withdrawing levoketoconazole to placebo versus continuing levoketoconazole treatment. The study, which included titration-maintenance, randomized withdrawal and restoration phases, met its previously reported primary endpoint of significantly more patients on placebo having loss of mean urinary-free cortisol (mUFC) response than those who continued on levoketoconazole at end of RW phase.

Restoration of levoketoconazole therapy reversed loss of cortisol control in most patients who had received placebo; of 20 placebo group patients with mUFC >ULN at restoration phase baseline, 12 (60%) were normalized at the end of the restoration phase. In the RW phase, mean total and LDL cholesterol levels were significantly increased with placebo versus levoketoconazole; these increases were reversed during the restoration phase. Throughout the study, no new safety signals of levoketoconazole treatment were identified, and known risks were manageable with appropriate monitoring.

The burden of illness (BOI) study captured the burden and health-related quality of life (HRQoL) associated with CS using validated patient reported outcome (PRO) measures of CushingQoL, Pain Visual Analog Scale (VAS), Brief Fatigue Inventory (BFI), PROMIS Sleep Disturbance (T-score) and PROMIS Anxiety SF 8a (T-score). Results showed that patients with CS experience a substantial and multi-faceted HRQoL burden. On the CushingQoL measure, respondents experienced moderate HRQoL impairment due to CS.

The mean VAS score was 3.6 out of 10, indicating relatively low levels of pain; however, 89% of all respondents reported taking over-the-counter analgesics to manage their symptoms. Patients reported moderate/severe fatigue (BFI), and moderate sleep and anxiety burden (PROMIS). Patients experienced symptoms of CS on approximately half the days in a typical month, and those who were employed missed 2 workdays every month, amounting to approximately 25 days per year due to CS.