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Chiesi announces phase 3 results from enzyme-replacement study
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Heading-module_container__uHf-4"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%"><h2><span style="font-family:"Roboto Slab"" class="__bold">Chiesi announces phase 3 results from enzyme-replacement study</span></h2></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p><span class="__bold" style="color:rgb(38,37,35)">Chiesi Global Rare Diseases has announced the results from its BRIGHT trial, which evaluates the efficacy of enzyme-replacement therapy drug ELFABRIO at twice the approved dose in patients who have been treated with agalsidase alfa or beta. The current approved dose of pegunigalside alfa-iwxj (ELFABRIO) is 1 milligram (mg) per kilogram (kg) administered every two weeks. </span></p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>The BRIGHT study, which was completed over the course of 52 weeks, contained 29 patients – only 21% of which were female. Results demonstrated that 30% of patients experienced at least one adverse reaction, which was mild or moderate. No patients developed novo anti-drug antibodies or treatment-emergent AEs that would have lead to a study discontinuation or mortality.</p></div></div><div id="outer" data-widget="image-widget" style="background-color:transparent;padding:8px 24px 16px 24px;min-height:auto" class="Widget-module_outer__PBh8P"><div id="inner" class="Image-module_container__8raIv Image-module_container-noflex__-J1PG" style="border-radius:0px 0px 0px 0px;width:100%;min-height:auto"><picture class="Image-module_picture__gw1zY Image-module_loading__FfyPr"><source type="image/jpeg" srcSet="https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=192 192w,https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=384 384w,https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=768 768w,https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=1536 1536w" sizes="(min-width: 768px) 768px, 100vw"/><img src="https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=768" srcSet="https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=192 192w,https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=384 384w,https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=768 768w,https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg?optimizer=image&width=1536 1536w" sizes="(min-width: 768px) 768px, 100vw" class="Image-module_image__w4slc" width="100%" height="902" decoding="async" alt="Image" style="height:auto;width:100%"/></picture></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>“We are pleased to share that the <span class="__italic" style="color:rgb(38,37,35)">Journal of Inherited Metabolic Disease </span>has published this data from this phase 3, open-label, multinational, switchover study evaluating the pharmacokinetics, safety and efficacy of 2mg/kg ELFABRIO administered every four weeks,” said Giacomo Chiesi, executive vice president of Chiesi Global Rare Diseases. “Chiesi is committed to evaluating additional evidence to confirm the long-term results of this administration schedule.”</p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>Fabry disease is a rare X-linked lysosomal disorder that results in excessive deposition of lipids in the tissues. Young patients usually present with stroke, skin lesions, heart attack, or renal failure.</p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>“Fabry disease today is witnessing the surge of innovative research into diverse treatments, which is a new dawn of hope rising on the horizon,” said Jack Johnson, vice president, Americas & Global, Fabry International Network and co-founder, executive director Fabry Disease Support & Information Group.</p></div></div></div></div></div><div class="_slug__share-button__ettip"><hr/></div></div></div><div id="ControlBar" class="_slug__control-bar__Jj4LE"><div class="WrapAutoHide-module_navigation__9sdQy WrapAutoHide-module_visible__UN7GD"><div 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","image":"https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg","cover":"https://cdn.magloft.com/publication-14882/screenshots/articles/269246.jpg?ts=1731322215","date":1731283200000,"unlockType":"free","categories":[],"pdfPageId":"mxv7OEWCjahc","visible":true,"showOnToc":true,"bookmark":false,"position":17,"publicationId":14882,"pwaOptinId":null,"seoDescription":"Chiesi Global Rare Diseases has announced the results from its BRIGHT trial, which evaluates the efficacy of enzyme-replacement therapy drug Elfabrio at twice the approved dose in patients who have been treated with agalsidase alfa or beta.","classificationIds":[],"pwaSubscriptionIds":[],"source":"typeloft2","trending":false,"html":"\u003cpage-widget padding=\"16 0 24 0\"\u003e\u003cparagraph-widget padding=\"0 24 0 24\"\u003eClinical Trials\u003c/paragraph-widget\u003e\u003chorizontal-rule-widget padding=\"0 24 0 24\" color=\"#a31f29\"\u003e\u003c/horizontal-rule-widget\u003e\u003cheading-widget padding=\"0 24 16 24\" type=\"h2\"\u003e\u003cspan style=\"font-family: \u0026quot;Roboto Slab\u0026quot;;\" class=\"__bold\"\u003eChiesi announces phase 3 results from enzyme-replacement study\u003c/span\u003e\u003c/heading-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003e\u003cspan class=\"__bold\" style=\"color: rgb(38,37,35)\"\u003eChiesi Global Rare Diseases has announced the results from its BRIGHT trial, which evaluates the efficacy of enzyme-replacement therapy drug ELFABRIO at twice the approved dose in patients who have been treated with agalsidase alfa or beta. The current approved dose of pegunigalside alfa-iwxj (ELFABRIO) is 1 milligram (mg) per kilogram (kg) administered every two weeks. \u003c/span\u003e\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eThe BRIGHT study, which was completed over the course of 52 weeks, contained 29 patients – only 21% of which were female. Results demonstrated that 30% of patients experienced at least one adverse reaction, which was mild or moderate. No patients developed novo anti-drug antibodies or treatment-emergent AEs that would have lead to a study discontinuation or mortality.\u003c/paragraph-widget\u003e\u003cimage-widget padding=\"8 24 16 24\" aspect-ratio=\"1.1742881794650561\" magnify-label=\"center\" source=\"https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg#image/jpeg\"\u003e\u003c/image-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003e“We are pleased to share that the \u003cspan class=\"__italic\" style=\"color: rgb(38,37,35)\"\u003eJournal of Inherited Metabolic Disease \u003c/span\u003ehas published this data from this phase 3, open-label, multinational, switchover study evaluating the pharmacokinetics, safety and efficacy of 2mg/kg ELFABRIO administered every four weeks,” said Giacomo Chiesi, executive vice president of Chiesi Global Rare Diseases. “Chiesi is committed to evaluating additional evidence to confirm the long-term results of this administration schedule.”\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eFabry disease is a rare X-linked lysosomal disorder that results in excessive deposition of lipids in the tissues. Young patients usually present with stroke, skin lesions, heart attack, or renal failure.\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003e“Fabry disease today is witnessing the surge of innovative research into diverse treatments, which is a new dawn of hope rising on the horizon,” said Jack Johnson, vice president, Americas \u0026amp; Global, Fabry International Network and co-founder, executive director Fabry Disease Support \u0026amp; Information Group.\u003c/paragraph-widget\u003e\u003c/page-widget\u003e","keywordPhrase":null,"articleAssets":[{"url":"https://cdn.magloft.com/reader/fonts/roboto-slab.css","extension":"css","contentType":"text/css"},{"url":"https://cdn.magloft.com/reader/fonts/open-sans.css","extension":"css","contentType":"text/css"},{"url":"https://cdn.magloft.com/pdf-import/1144/images/img_10-2.jpg","extension":"jpeg","contentType":"image/jpeg"}]},"publicationId":14882},"__N_SSG":true},"page":"/domains/[domain]/articles/[slug]","query":{"domain":"www.pharmafocus.com","slug":"chiesi-announces-phase-3-results-from-enzyme-replacement-study"},"buildId":"U1LT7ce93wR6IyWFJCllT","isFallback":false,"gsp":true,"scriptLoader":[]}</script></body></html>