{"id":164,"date":"2022-10-14T16:28:06","date_gmt":"2022-10-14T16:28:06","guid":{"rendered":"https:\/\/brineurahcp-dev-001.azurewebsites.net\/en-us\/brineura\/?page_id=164"},"modified":"2026-03-11T12:47:25","modified_gmt":"2026-03-11T12:47:25","slug":"results","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/brineura\/results\/","title":{"rendered":"Efficacy"},"content":{"rendered":"<div id=\"acf-block-6492fb185f4b8\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6492fb185f6bb\" class=\"block-wysiwyg\">\n            <h1>Brineura\u00ae (cerliponase alfa) clinical studies: efficacy results<\/h1>\n<p>Brineura\u00ae (cerliponase alfa) injection for intraventricular infusion is indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency.<sup>1<\/sup><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f6cf\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6492fb185f6ec\" class=\"block-wysiwyg\">\n            <h3 class=\"p1\">Trials 1 and 2<\/h3>\n<h2>Brineura helped maintain patients&#8217; motor function by slowing the loss of ambulation compared with natural history<sup>1<\/sup><\/h2>\n<h5><strong>Decline<\/strong> was defined as an unreversed (sustained) 2-point loss or an unreversed score of 0 in the Motor domain of the CLN2 Clinical Rating Scale.<sup>1<\/sup><\/h5>\n    <\/div>\n\n<figure id=\"acf-block-6492fb185f706\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/wp-content\/uploads\/sites\/2\/2022\/10\/chart1.svg\" alt=\"clinical study efficacy results\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-6492fb185f749\" class=\"block-wysiwyg\">\n            <ul>\n<li>95% of patients treated with Brineura (21\/22) did not show <strong>Decline <\/strong>compared with 50% in the natural history cohort (21\/42)<sup>1<\/sup>\n<ul>\n<li>The only Brineura-treated patient deemed to have <strong>Decline<\/strong> discontinued from the study after 1 infusion due to inability to continue with study procedures<sup>1<\/sup><\/li>\n<li>Ten Brineura-treated patients experienced 1-point loss on the Motor domain of the CLN2 Clinical Rating Scale while on the 300 mg dose<sup>2<\/sup><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"p1\"><strong>Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Such reactions have occurred during and up to 24 hours after completion of the Brineura infusion.<sup>1<\/sup><\/strong><\/p>\n<p><strong>Brineura is contraindicated in patients with acute intraventricular access device\u2013related complications or ventriculoperitoneal shunts. Cardiovascular and infusion-associated reactions related to Brineura may occur.<sup>1<\/sup><\/strong><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f761\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6492fb185f775\" class=\"block-wysiwyg\">\n            <h2>Fewer patients treated with Brineura declined vs natural history cohort<sup>1<\/sup><\/h2>\n<h5><strong>Decline<\/strong> was defined as a sustained 2-point loss or an unreversed score of 0 in the Motor domain of the CLN2 Clinical Rating Scale.<sup>1<\/sup><\/h5>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f789\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-6492fb185f79f\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/wp-content\/uploads\/sites\/2\/2022\/10\/chart2.svg\" alt=\"motor function chart\" \/>            <\/div>\n            <figcaption><p><small>*94% of Brineura-treated patients (16\/17) had no decline in motor function from week 48 through 96.<sup>1<\/sup><\/small><\/p>\n<\/figcaption>\n    <\/figure>\n\n<div id=\"acf-block-6492fb185f7b3\" class=\"block-wysiwyg\">\n            <ul>\n<li>Matched-population analysis based on baseline age at time of screening within 3 months, genotype (0, 1, or 2 key mutations), and baseline Motor domain CLN2 score at time of screening<sup>1<\/sup><\/li>\n<li>17 of the 23 enrolled patients were matched with natural history controls based on specific criteria. This was a matched analysis based on the 17 pairs<sup>1<\/sup><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f7bd\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6492fb185f7ce\" class=\"block-wysiwyg\">\n            <h2>Brineura-treated patients better maintained motor function over time vs natural history patients<sup>1<\/sup><\/h2>\n<p>Cox Proportional Hazards Model adjusted for age, initial motor score, and genotype was used to evaluate time to unreversed 2-point <strong>Decline<\/strong> or unreversed score of 0 in the Motor domain.<sup>1<\/sup><\/p>\n    <\/div>\n\n<figure id=\"acf-block-6492fb185f7ef\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/wp-content\/uploads\/sites\/2\/2022\/10\/chart5.svg\" alt=\"Brineura-treated patients better maintained motor function over time vs untreated patients\" \/>            <\/div>\n            <figcaption><p><small>Follow-up began at \u226536 months of age and the first recorded Motor plus Language CLN2 score &lt;6 for the natural history cohort. The Brineura-treated population included all 24 patients, with the exception of the 2 patients whose baseline Motor plus Language CLN2 score was 6.<sup>1<\/sup><\/small><\/p>\n<p><small>Covariates: screening age; screening Motor score; genotype: 0 key mutations (yes\/no). In the natural history cohort: &#8220;screening age&#8221; was the age (\u226536 months) when a Motor plus Language CLN2 score &lt;6 was first recorded; &#8220;screening Motor score&#8221; was the Motor score at the screening age.<sup>1<\/sup><\/small><\/p>\n<p><small><strong>Decline<\/strong> was defined as a sustained 2-point loss or unreversed score of 0 in the Motor domain of the CLN2 Clinical Rating Scale.<sup>1<\/sup><\/small><\/p>\n<\/figcaption>\n    <\/figure>\n\n<div id=\"acf-block-6492fb185f807\" class=\"block-wysiwyg\">\n            <p>In clinical Trials 1 and 2, the most frequently reported adverse reactions (\u22658%) were pyrexia, ECG abnormalities, CSF protein decreased, vomiting, seizures, hypersensitivity, CSF protein increased, hematoma, headache, irritability, pleocytosis, device-related infection, bradycardia, feeling jittery, and hypotension. Adverse reactions related to the device were observed in 12 of 24 (50%) of patients. Device-related adverse reactions include infection, delivery system-related complications, and pleocytosis.<sup>1<\/sup><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68f1fbe6d4471\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68f1fbe6d45bd\" class=\"block-wysiwyg\">\n            <h3>Trial 3<\/h3>\n<h2><b>At 169 weeks, none of the <\/b><b>Brineura<\/b><b>-treated patients had a 2-point decline or score of zero in the Motor domain of the CLN2 Clinical Rating Scale vs the matched natural history controls<sup>1<\/sup><\/b><\/h2>\n<h5><b>Decline <\/b>was defined as having an unreversed (sustained) 2-point decline, or an unreversed score of 0, in the Motor domain of the CLN2 Clinical Rating Scale.<sup>1<\/sup><\/h5>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68f1fbe6d4608\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-68f1fbe6d47e1\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/wp-content\/uploads\/sites\/2\/2025\/11\/AbsenceOfDecline_nobackground-1900x664.png\" alt=\"\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-691f142e46b7b\" class=\"block-wysiwyg\">\n            <ul style=\"margin: 0;padding-left: 18px;line-height: 1.0\">\n<li><small>Among the matched natural history comparators (N=31), 20 subjects (65%) had an unreversed 2-point decline or score of 0 by last assessment while none of the Brineura-treated patients (N=14) had a 2-point decline or score of 0 in the Motor scale by last assessment<sup>1<\/sup><\/small><\/li>\n<li><small>The median time to an unreversed 2-point decline in Motor scale or score of 0 was 133 weeks among the natural history comparators<sup>1<\/sup><\/small><\/li>\n<li><small>In patients below 3 years of age (N=8), none (0%) of the Brineura-treated patients (N=8) had a 2-point decline or score of zero in the Motor score by Week 169<sup>1<\/sup><\/small>\n<ul style=\"margin: 0;padding-left: 18px;line-height: 1.0\">\n<li><small>All 7 of the treated patients below 3 years of age with a Motor score of 3 at baseline remained at a Motor score of 3 at the last measured timepoint, which represents grossly normal gait. In this population, Brineura-treated patients showed a delay in disease onset<sup>1<\/sup><\/small><\/li>\n<\/ul>\n<\/li>\n<li><small>Among the 8 treated patients, 7 were matched to 18 untreated patients from the natural history cohort<sup>1<\/sup><\/small><\/li>\n<li><small>Among the matched natural history comparators (N=18), 11 subjects (61%) had an unreversed 2-point decline or score of zero in the Motor score by last assessment<sup>1<\/sup><\/small><\/li>\n<\/ul>\n<p><strong>The most frequent adverse reactions reported in patients &lt;3 years of age treated with Brineura were similar to those observed in patients \u22653 years of age except for hypersensitivity reactions, which were reported in 5 of 8 (63%) in patients &lt;3 years of age at baseline compared with 0 of 6 patients \u22653 years of age at baseline. The most common manifestations of hypersensitivity were pyrexia and vomiting and the timing and resolution were similar to Trials 1 &amp; 2.<\/strong><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68f1fbe6d4828\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68f1fbe6d485f\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f81a\" class=\"block cards cards-3-col\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"cards-title\">\n\t\t\t    \t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"cards-wrapper\">\n\t\t\t    \n<div id=\"acf-block-6492fb185f834\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>Connect with BioMarin to register for Brineura updates\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/register\/\" target=\"_self\">Register Now<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f84f\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>Brineura safety was evaluated in 38 patients with CLN2 disease across multiple clinical studies\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/safety\/\" target=\"_self\">See Safety Profile<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f868\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>Download helpful materials for you and your patients\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/resources\/\" target=\"_self\">View Resources<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f885\" class=\"block call-to-action call-to-action-no-overlay\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t    \t\t\t\t\t<div class=\"cta-content-main\">\n                        <div class=\"content-block\">\n\t\t\t\t\t        \t\t\t\t\t        \t\t\t\t\t\t        <h2 class=\"h3\">Brineura Safety Profile\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p class=\"p1\">Brineura safety was evaluated in 38 patients with CLN2 disease across multiple clinical studies<\/p>\n\t\t\t\t\t\t    \t\t\t\t\t    <\/div>\n\t\t\t\t\t                                <div class=\"content-block\">\n                                <p><a class=\"button button-ghost button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/safety\/\" target=\"_self\">Next Section<\/a><\/p>\n                            <\/div>\n\t\t\t\t\t                        <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6492fb185f89a\" class=\"block references\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>References:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>Brineura [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2024.\n<\/span><\/li>\n                                                                                                                                                <li><span>Data on file, BioMarin Pharmaceutical Inc.\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-164","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Efficacy - BioMarin Brineura HCP EN-US<\/title>\n<meta name=\"description\" content=\"Brineura\u00ae (cerliponase alfa) injection for intraventricular infusion is indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/results\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Efficacy\" \/>\n<meta property=\"og:description\" content=\"Brineura\u00ae (cerliponase alfa) injection for intraventricular infusion is indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/hcp.biomarin.com\/en-us\/brineura\/results\/\" \/>\n<meta property=\"og:site_name\" content=\"BioMarin Brineura HCP EN-US\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-11T12:47:25+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/hcp.biomarin.com\\\/en-us\\\/brineura\\\/results\\\/\",\"url\":\"https:\\\/\\\/hcp.biomarin.com\\\/en-us\\\/brineura\\\/results\\\/\",\"name\":\"Efficacy - 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