{"id":387482,"date":"2020-11-24T07:33:28","date_gmt":"2020-11-24T12:33:28","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=387482"},"modified":"2020-11-24T07:33:28","modified_gmt":"2020-11-24T12:33:28","slug":"strongbridge-biopharma-plc-announces-publication-of-secondary-endpoints-data-from-phase-3-sonics-study-of-recorlev-levoketoconazole-for-the-treatment-of-endogenous-cushings-syndrom","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-publication-of-secondary-endpoints-data-from-phase-3-sonics-study-of-recorlev-levoketoconazole-for-the-treatment-of-endogenous-cushings-syndrom\/","title":{"rendered":"Strongbridge Biopharma plc Announces Publication of Secondary Endpoints Data from Phase 3 SONICS Study of RECORLEV\u2122 (levoketoconazole) for the Treatment of Endogenous Cushing\u2019s Syndrome in the Journal, Pituitary"},"content":{"rendered":"<h2>\n~ RECORLEV\u2122 (levoketoconazole) Treatment Resulted in Significantly Improved Clinician-Assessed Signs and Symptoms and Patient-Reported Outcomes of Cushing\u2019s Syndrome ~<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"justify\">DUBLIN, Ireland and TREVOSE, Pa., Nov.  24, 2020  (GLOBE NEWSWIRE) &#8212; Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that secondary endpoint results from the Phase 3 SONICS study of RECORLEV\u2122 (levoketoconazole) for the potential treatment of endogenous Cushing\u2019s syndrome were published online in advance of print publication in the peer-reviewed journal,\u00a0<em>Pituitary<\/em>, the official publication of the Pituitary Society and the Growth Hormone Research Society.<\/p>\n<p align=\"justify\">\u201cPeople with Cushing\u2019s syndrome often experience a variety of problematic signs, symptoms, and comorbidities related to excess cortisol, testosterone or both,\u201d said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. \u201cThe SONICS study provided important evidence that RECORLEV treatment was associated with durable improvements in several of the more common and bothersome signs and symptoms of the syndrome, including those that most commonly affect women, such as hirsutism and acne, which are related to increases in testosterone produced by the adrenal glands.\u201d<\/p>\n<p align=\"justify\">The manuscript, entitled \u201c<strong>Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing\u2019s syndrome<\/strong>,\u201d includes analyses demonstrating that treatment with RECORLEV led to significant improvements in Cushing\u2019s syndrome signs and symptoms, patient-reported quality of life (QoL) outcomes, depression symptoms, and testosterone levels.<\/p>\n<ul type=\"disc\">\n<li style=\"margin-top:5pt;margin-bottom:7.5pt;text-align:justify\">Significant mean improvements from baseline were noted at end of the Maintenance phase (Month 6) for acne, hirsutism (females only), and peripheral edema.<\/li>\n<li style=\"margin-top:5pt;margin-bottom:7.5pt;text-align:justify\">These improvements were observed as early as Day 1 of Maintenance for hirsutism, the end of Month 1 of Maintenance for acne, and Month 4 of Maintenance for peripheral edema.<\/li>\n<li style=\"margin-top:5pt;margin-bottom:7.5pt;text-align:justify\">By Month 3 of Maintenance, significant mean improvements in patient-reported QoL outcomes were observed and by Month 6, symptoms of depression had improved.<\/li>\n<li style=\"margin-top:5pt;margin-bottom:7.5pt;text-align:justify\">A reduction in mean free-testosterone in women, consistent with improvements in clinical signs of hyperandrogenism was observed, and a modest increase in mean free-testosterone in men was observed.<\/li>\n<li style=\"margin-top:5pt;margin-bottom:7.5pt;text-align:justify\">RECORLEV was generally well-tolerated; the most commonly reported adverse events during the dose-titration and maintenance phases were nausea (32%) and headache (28%).<\/li>\n<\/ul>\n<p>The full manuscript can be accessed online at:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=83KFySomMpHdNBTwTgb2MtRK3JeuGnaDyhMskYzROnfSkPktkcAyVbMpLgJmCOmITjQAfuub8Z3SasRqQdWcF6bt3nOjFreX7UghhTBeXem_J_ztmJDPhLsXGW8Gef9azdJDJJpBcWm1SyKtfO-5uhdrFyrkGwnuSPvp8Px2uBDoeazjoL9Nqs8BuwrTe97VPEm6ABqIrEetWuFqPU10Ttq2yNzURntyIEYS8V3DqYEaVeDdQA9zZc5WIta98aODvmIOE43I4kszezawPoUCWzSfl8reWrR2ex33fLfUUOFmzFyd252aPdDf66mfxjfoLvd-TbUlEaMlFR-LR9jAycx9Bnoih98qtWwd9Aw_msM=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">https:\/\/www.strongbridgebio.com\/therapeutic-focus\/key-publications-posters\/related-investigational-agent-recorlev\/#heading_4<\/a><\/p>\n<p align=\"justify\">\n        <strong>About Cushing\u2019s Syndrome<\/strong><br \/>\n        <br \/>Endogenous Cushing\u2019s syndrome is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure &#8211; 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, and this often results in undesirable physical changes. The disease is most common among adults between the ages of 30 to 50, and it affects women three times more often than men. Women with Cushing&#8217;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. Additionally, the internal manifestations 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 psychologic disturbances such as depression, anxiety and insomnia. Untreated, the five-year survival rate is only approximately 50 percent.<\/p>\n<p align=\"justify\">\n        <strong>About<\/strong><br \/>\n        <strong>\u00a0<\/strong><br \/>\n        <strong>the<\/strong><br \/>\n        <strong>\u00a0<\/strong><br \/>\n        <strong>SONICS<\/strong><br \/>\n        <strong>\u00a0<\/strong><br \/>\n        <strong>Study<\/strong><br \/>\n        <br \/>SONICS is an open-label, Phase 3 study of RECORLEV as a treatment for endogenous Cushing\u2019s syndrome that enrolled 94 patients at centers in\u00a0North America,\u00a0Europe\u00a0and the\u00a0Middle East. Following a screening phase, SONICS has three treatment phases:<\/p>\n<p align=\"justify\">(1) Dose Titration Phase: Patients started RECORLEV at 150 mg twice daily (300 mg total daily dose) and titrated in 150 mg increments with the goal of achieving a therapeutic dose \u2013 a dose resulting in mUFC normalization \u2013 at which point titration was stopped; (2) Maintenance Phase: The dose was fixed and should not have been changed other than for safety reasons or loss of efficacy. At the end of the six-month maintenance phase, the mUFC response rate was measured; and (3) Extended Evaluation Phase: Patients continued on RECORLEV for another six months to evaluate long-term safety and tolerability and explore efficacy durability.<\/p>\n<p align=\"justify\">\n        <strong>About RECORLEV<\/strong><br \/>\n        <br \/>RECORLEV<sup>\u00ae<\/sup> (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing\u2019s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure.\u00a0RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV has demonstrated in two successful Phase 3 studies to significantly suppress serum cortisol and has the potential to be a next-generation\u00a0cortisol\u00a0inhibitor.<\/p>\n<p>The Phase 3 program for RECORLEV includes SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing\u2019s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months.\u00a0The LOGICS study, which met its primary endpoint, is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS. The ongoing long-term open label OPTICS study will gather further useful information related to the long-term use of RECORLEV.<\/p>\n<p align=\"justify\">RECORLEV has received orphan drug designation from the FDA and the\u00a0European Medicines Agency\u00a0for the treatment of endogenous\u00a0Cushing&#8217;s\u00a0syndrome.<\/p>\n<p align=\"justify\">\n        <strong>About Strongbridge Biopharma<\/strong><br \/>\n        <br \/>Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge\u2019s rare endocrine franchise includes RECORLEV<sup>\u00ae<\/sup> (levoketoconazole), a cortisol synthesis inhibitor currently being studied\u00a0in Phase 3 clinical studies\u00a0for the treatment of endogenous Cushing\u2019s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation.\u00a0Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency.\u00a0The Company\u2019s rare neuromuscular franchise includes KEVEYIS<sup>\u00ae<\/sup>\u00a0(dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>\n        <em>This press release contains forward-looking statements within the meaning of the federal securities laws. The words \u201canticipate,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould,\u201d or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to\u00a0the<\/em><br \/>\n        <em>secondary endpoint data from the SONICS <\/em><br \/>\n        <em> study<\/em><br \/>\n        <em>, the potential advantages of RECORLEV,\u00a0 Strongbridge\u2019s strategy, plans, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients.\u00a0 Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading \u201cRisk Factors\u201d in Strongbridge\u2019s Annual Report on Form 10-K for the year ended\u00a0December 31, 2019\u00a0and <\/em><br \/>\n        <em>its <\/em><br \/>\n        <em>subsequent <\/em><br \/>\n        <em>Quarterly Reports on Form 10-Q, as well as its other <\/em><br \/>\n        <em>filings with the\u00a0SEC. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and\u00a0Strongbridge Biopharma\u00a0does not assume any obligation to update any forward-looking statements except as required by applicable law.<\/em>\n      <\/p>\n<p align=\"justify\">\n        <strong>Contacts:<\/strong>\n      <\/p>\n<p>\n        <strong>Corporate and Media Relations<\/strong><br \/>\n        <br \/>Elixir Health Public Relations<br \/>Lindsay Rocco<br \/>+1 862-596-1304<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=D-ribY8AEzNIJdXtDchz3HkfqMMSwbN0rpwLRXz_vCSXy0Mj0XL7GD7ZOnkkjESRwMSWkyHRtLt_a41Ch0p3JLiLVi-iYM-Q_Czb36OvLtI=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><strong>lrocco@elixirhealthpr.com<\/strong><\/a><\/p>\n<p>\n        <strong>Investor Relations<\/strong><br \/>\n        <br \/>Solebury Trout<br \/>Mike Biega<br \/>+1 617-221-9660<br \/><strong><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=IcAgpNlbDCo1bclUhwKY1dynRMbU3Hqp7j_R3Vgo4MFK0LwQ35hAKZwU42zMJE3eBYHPTU9383CfUHljAq-S6btv19neZcFFRCi3U7-suRs=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">mbiega@soleburytrout.com<\/a><\/strong>\u00a0<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5MTEyMyMzODQwOTkyIzIwMjAwMjU=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/2b44fb57-9e23-4e19-843a-b16c9151283b\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>~ RECORLEV\u2122 (levoketoconazole) Treatment Resulted in Significantly Improved Clinician-Assessed Signs and Symptoms and Patient-Reported Outcomes of Cushing\u2019s Syndrome ~ DUBLIN, Ireland and TREVOSE, Pa., Nov. 24, 2020 (GLOBE NEWSWIRE) &#8212; Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that secondary endpoint results from the Phase 3 SONICS study of RECORLEV\u2122 (levoketoconazole) for the potential treatment of endogenous Cushing\u2019s syndrome were published online in advance of print publication in the peer-reviewed journal,\u00a0Pituitary, the official publication of the Pituitary Society and the Growth Hormone Research Society. \u201cPeople with Cushing\u2019s syndrome often experience a variety of problematic signs, symptoms, and comorbidities related to excess &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-publication-of-secondary-endpoints-data-from-phase-3-sonics-study-of-recorlev-levoketoconazole-for-the-treatment-of-endogenous-cushings-syndrom\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Strongbridge Biopharma plc Announces Publication of Secondary Endpoints Data from Phase 3 SONICS Study of RECORLEV\u2122 (levoketoconazole) for the Treatment of Endogenous Cushing\u2019s Syndrome in the Journal, Pituitary&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-387482","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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