{"id":7121,"date":"2025-06-12T09:56:35","date_gmt":"2025-06-12T09:56:35","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/?page_id=7121"},"modified":"2025-11-17T19:12:10","modified_gmt":"2025-11-17T19:12:10","slug":"trial-results-design","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/","title":{"rendered":"Trial Design"},"content":{"rendered":"
\n
\n
<\/div>\n
<\/div>\n
<\/div>\n
\n
\n
\n

PALYNZIQ WAS
\nSTUDIED ACROSS
\nPKU AND
\nPATIENT TYPES<\/span>\n<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\n \n
\n\t
\n\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t\t\n
\n

A wide range of adult patients enrolled in the PALYNZIQ®<\/sup> (pegvaliase-pqpz) Injection clinical trials, including those with classical or severe PKU.1,2<\/sup><\/p>\n <\/div>\n\n

\n
\n
\n\t\t\t \"\"\t\t\t<\/div>\n\t\t\t
\n\t\t\t \"\"\t\t\t<\/div>\n <\/div>\n <\/figure>\n\n
\n
\n
\n\t\t\t \"\"\t\t\t<\/div>\n\t\t\t
\n\t\t\t \"\"\t\t\t<\/div>\n <\/div>\n <\/figure>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n
\n\t
\n\t\t
\n\t\t
\n
\n
\n <\/span>\n <\/span>\n <\/div>\n

See PALYNZIQ clinical trial design\n<\/h2>\n <\/div>\n
\n \n \"\" \"\" <\/div>\n <\/div>\n \t\t<\/div>\n\t<\/div>\n<\/div>\n <\/div>\n <\/div>\n
<\/div>\n
<\/div>\n <\/div>\n\n
\n
\n
\n \n
\n

*The phase 3 PRISM trial for PALYNZIQ enrolled 261 individuals regardless of baseline Phe or dietary Phe restriction; adherence to <\/small>existing management did not exclude participation.1 <\/sup><\/small>
\n\u2020<\/sup>A Phe-restricted diet is defined as >75% of protein intake from medical food.1 <\/sup><\/small>
\n\u2021<\/sup>Patients aged 16-17 years were initially included in the trial prior to a protocol amendment.2 <\/sup><\/small>
\n\u00a7<\/sup>Patients were randomized 2:1 to either continue their randomized dosage of PALYNZIQ (20 mg or 40 mg once daily) or receive <\/small>matching placebo.1,2<\/sup><\/small><\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n

\n
\n

See results with PALYNZIQ <\/a><\/p>\n <\/div>\n<\/div>\n\n

\n
\n
\n \n
\n

References: 1.<\/strong> PALYNZIQ [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2025. 2.<\/strong> Thomas J, Levy H, Amato S, et al, for the PRISM investigators. Pegvaliase for the treatment of phenylketonuria: results of a long-term phase 3 clinical trial program (PRISM). Mol Genet Metab<\/em>. 2018;124(1):27-38.doi:10.1016\/j.ymgme.2018.03.006 3.<\/strong> Data on file. BioMarin Pharmaceutical Inc. 4.<\/strong> Qi Y, Patel G, Henshaw J, et al. Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria. Clin Transl Sci.<\/em> 2021;14(5):1894-1905. doi:10.1111\/cts.13043 5.<\/strong> Harding CO, Longo N, Northrup H, et al. Pegvaliase for the treatment of phenylketonuria: final results of a long-term phase 3 clinical trial program. Mol Genet Metab Rep.<\/em> 2024;39:101084. doi:10.1016\/j.ymgmr.2024.101084<\/small><\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"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-7121","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nBioMarin PALYNZIQ HCP | PALYNZIQ\u00ae Clinical Trials<\/title>\n<meta name=\"description\" content=\"Explore data on how the efficacy of PALYNZIQ\u00ae was measured.\" \/>\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\/palynziq\/trial-results-design\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioMarin PALYNZIQ HCP | PALYNZIQ\u00ae Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"Explore data on how the efficacy of PALYNZIQ\u00ae was measured.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/\" \/>\n<meta property=\"og:site_name\" content=\"BioMarin Palynziq HCP EN-US\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-17T19:12:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-content\/uploads\/sites\/3\/2023\/03\/palynziq-cover.jpg?v=0.117\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"675\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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\/palynziq\/trial-results-design\/\",\"url\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/\",\"name\":\"BioMarin PALYNZIQ HCP | PALYNZIQ\u00ae Clinical Trials\",\"isPartOf\":{\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/#website\"},\"datePublished\":\"2025-06-12T09:56:35+00:00\",\"dateModified\":\"2025-11-17T19:12:10+00:00\",\"description\":\"Explore data on how the efficacy of PALYNZIQ\u00ae was measured.\",\"breadcrumb\":{\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Trial Design\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/#website\",\"url\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/\",\"name\":\"BioMarin Palynziq HCP EN-US\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"BioMarin PALYNZIQ HCP | PALYNZIQ\u00ae Clinical Trials","description":"Explore data on how the efficacy of PALYNZIQ\u00ae was measured.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/","og_locale":"en_US","og_type":"article","og_title":"BioMarin PALYNZIQ HCP | PALYNZIQ\u00ae Clinical Trials","og_description":"Explore data on how the efficacy of PALYNZIQ\u00ae was measured.","og_url":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/","og_site_name":"BioMarin Palynziq HCP EN-US","article_modified_time":"2025-11-17T19:12:10+00:00","og_image":[{"width":1200,"height":675,"url":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-content\/uploads\/sites\/3\/2023\/03\/palynziq-cover.jpg?v=0.117","type":"image\/jpeg"}],"twitter_card":"summary_large_image","schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/","url":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/","name":"BioMarin PALYNZIQ HCP | PALYNZIQ\u00ae Clinical Trials","isPartOf":{"@id":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/#website"},"datePublished":"2025-06-12T09:56:35+00:00","dateModified":"2025-11-17T19:12:10+00:00","description":"Explore data on how the efficacy of PALYNZIQ\u00ae was measured.","breadcrumb":{"@id":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-design\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/"},{"@type":"ListItem","position":2,"name":"Trial Design"}]},{"@type":"WebSite","@id":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/#website","url":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/","name":"BioMarin Palynziq HCP EN-US","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/pages\/7121","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/comments?post=7121"}],"version-history":[{"count":74,"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/pages\/7121\/revisions"}],"predecessor-version":[{"id":7807,"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/pages\/7121\/revisions\/7807"}],"wp:attachment":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-json\/wp\/v2\/media?parent=7121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}