Post by icemandios on May 12, 2022 23:16:18 GMT
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
Xeris 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.
Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study (abstract link here)
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 full data will be shared during a poster presentation scheduled for May 12, 1:00–1:15 PM (PST).
Patient-Reported Burden of Illness in Endogenous Cushing’s Syndrome (abstract link here)
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.
The full data will be shared during a poster presentation scheduled for May 12, 4:10–4:25 PM (PST).
About Cushing’s Syndrome
Endogenous Cushing’s syndrome is a rare, serious, and potentially fatal endocrine disease caused by chronic elevated cortisol exposure–often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, which often results in characteristic physical signs and symptoms that are distressing to patients. The disease is most common among adults between the ages of 30–50, and it affects women three times more often than men. Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone, which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. 3
Additionally, the multisystem complications of the disease are potentially life threatening. These include metabolic changes such as high blood sugar or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle, and bone, and psychological disturbances such as depression, anxiety, and insomnia. 3 Untreated, the five-year survival rate is only approximately 50%. 4
About Recorlev
Recorlev ® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 1 Endogenous Cushing’s syndrome is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. 2 Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. 1 Recorlev has demonstrated in two successful Phase 3 studies to significantly reduce mean urine free cortisol. 1
The Phase 3 program for Recorlev included SONICS and LOGICS, two multinational studies designed to evaluate the safety and efficacy of Recorlev when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase. 1,2 The LOGICS study, which met its primary endpoint and key secondary endpoint, was a double-blind, placebo-controlled randomized-withdrawal study of Recorlev that was designed to supplement the efficacy and safety information provided by SONICS. 1 The ongoing open-label OPTICS study will gather further useful information related to the long- term use of Recorlev.
Recorlev received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.
Xeris 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.
Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study (abstract link here)
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 full data will be shared during a poster presentation scheduled for May 12, 1:00–1:15 PM (PST).
Patient-Reported Burden of Illness in Endogenous Cushing’s Syndrome (abstract link here)
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.
The full data will be shared during a poster presentation scheduled for May 12, 4:10–4:25 PM (PST).
About Cushing’s Syndrome
Endogenous Cushing’s syndrome is a rare, serious, and potentially fatal endocrine disease caused by chronic elevated cortisol exposure–often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, which often results in characteristic physical signs and symptoms that are distressing to patients. The disease is most common among adults between the ages of 30–50, and it affects women three times more often than men. Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone, which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. 3
Additionally, the multisystem complications of the disease are potentially life threatening. These include metabolic changes such as high blood sugar or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle, and bone, and psychological disturbances such as depression, anxiety, and insomnia. 3 Untreated, the five-year survival rate is only approximately 50%. 4
About Recorlev
Recorlev ® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 1 Endogenous Cushing’s syndrome is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. 2 Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. 1 Recorlev has demonstrated in two successful Phase 3 studies to significantly reduce mean urine free cortisol. 1
The Phase 3 program for Recorlev included SONICS and LOGICS, two multinational studies designed to evaluate the safety and efficacy of Recorlev when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase. 1,2 The LOGICS study, which met its primary endpoint and key secondary endpoint, was a double-blind, placebo-controlled randomized-withdrawal study of Recorlev that was designed to supplement the efficacy and safety information provided by SONICS. 1 The ongoing open-label OPTICS study will gather further useful information related to the long- term use of Recorlev.
Recorlev received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.