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Xeris Announces Full Results From the Logics Study of Recorlev® and Presentation of New Burden of Illness in Cushing’s Syndrome Data at AACE Annual Meeting May 12-14
CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":" CHICAGO--(BUSINESS WIRE)--\nXeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today 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.\n\nLevoketoconazole in the Treatment of Endogenous Cushing’s Syndrome: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study (abstract link here)\n\nLOGICS, 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.\n\nThe full data will be shared during a poster presentation scheduled for May 12, 1:00–1:15 PM (PST).\n\nPatient-Reported Burden of Illness in Endogenous Cushing’s Syndrome (abstract link here)\n\nThe 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...