{"id":942,"date":"2020-01-10T17:26:14","date_gmt":"2020-01-10T17:26:14","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=942"},"modified":"2021-02-10T18:37:39","modified_gmt":"2021-02-10T18:37:39","slug":"apellis-reports-positive-top-line-results-from-phase-3-head-to-head-study-of-pegcetacoplan-apl-2-2","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/apellis-reports-positive-top-line-results-from-phase-3-head-to-head-study-of-pegcetacoplan-apl-2-2\/","title":{"rendered":"Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2)"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">News Release<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)<\/h3>\n\n\n\n<p>January 7, 2020<\/p>\n\n\n\n<ul><li><em>Pegcetacoplan met the primary endpoint in the PEGASUS study, demonstrating superiority to eculizumab&nbsp;<\/em>(p&lt;0.0001)&nbsp;<em>with an improvement in adjusted means of 3.8 g\/dL of hemoglobin at week 16<\/em><\/li><li><em>Safety profile of pegcetacoplan was comparable to eculizumab in this study<\/em><\/li><li><em>Conference call scheduled today at 8:30 a.m. ET<\/em><\/li><\/ul>\n\n\n\n<p>WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) &#8212; &nbsp;<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=z3JE0KfO-yuOwFmI-5DStEGbrUGbWwdKw7PHbTt7OE1FI-cfZ5HLBAuxNyqY5CV9e__bFfqHSGEh5wrxLImqVP3e3b2hsljy3FZmYO1Ub6kKzsXevvjKgWPQvS0SMqzs4IaItU0bC9ez67qhHPP1WpzBWgrFrCahepF_JAmXcyGcNxtF-PoVoEDRfk08KQRjdppQPHDNPu77AsVcLp4kQ_KmAdgOKyotFjQS1X2uwq0yXKY_RkbBY3DpWRCL2NInvffkZ2iVGBPlnpUiel9eIw==\" rel=\"noreferrer noopener\" target=\"_blank\">Apellis Pharmaceuticals<\/a>,&nbsp;Inc. (Nasdaq: APLS), a global biopharmaceutical company pioneering targeted C3 therapies, today announced positive results from the Phase 3 PEGASUS study evaluating pegcetacoplan (APL-2) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Top-line data show that pegcetacoplan met the study\u2019s primary efficacy endpoint, demonstrating superiority to eculizumab with a statistically significant improvement in adjusted means of 3.8 g\/dL of hemoglobin at week 16 (p&lt;0.0001). At week 16, pegcetacoplan-treated patients (n=41) had an adjusted mean hemoglobin increase of 2.4 g\/dL from a baseline of 8.7 g\/dL, compared to eculizumab-treated patients (n=39) who had a change of -1.5 g\/dL from a baseline of 8.7 g\/dL.<\/p>\n\n\n\n<p>Additionally, pegcetacoplan showed promising results in key secondary endpoints. Pegcetacoplan met non-inferiority on transfusion avoidance and absolute reticulocyte count. Pegcetacoplan also showed positive trends on lactate dehydrogenase (LDH) and fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue score.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/investors.apellis.com\/news-releases\/news-release-details\/apellis-reports-positive-top-line-results-phase-3-head-head\">Read Full Report<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>News Release Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) January 7, 2020 Pegcetacoplan met the primary endpoint in the PEGASUS study, demonstrating superiority to eculizumab&nbsp;(p&lt;0.0001)&nbsp;with an improvement in adjusted&#8230;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[103],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.2 - 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