{"id":1603,"date":"2020-01-07T15:18:08","date_gmt":"2020-01-07T23:18:08","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=1603"},"modified":"2021-05-13T14:26:22","modified_gmt":"2021-05-13T22:26:22","slug":"apellis-reports-positive-top-line-results-from-phase-3-head-to-head-study-of-pegcetacoplan-apl-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\/","title":{"rendered":"Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2)"},"content":{"rendered":"<p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;grid&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; z_index=&#8221;&#8221;][vc_column][vc_column_text]<\/p>\n<h2>News Release<\/h2>\n<h3>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<ul>\n<li><em>Pegcetacoplan met the primary endpoint in the PEGASUS study, demonstrating superiority to eculizumab\u00a0<\/em>(p&lt;0.0001)\u00a0<em>with an improvement in adjusted means of 3.8 g\/dL of hemoglobin at week 16<\/em><\/li>\n<li><em>Safety profile of pegcetacoplan was comparable to eculizumab in this study<\/em><\/li>\n<li><em>Conference call scheduled today at 8:30 a.m. ET<\/em><\/li>\n<\/ul>\n<p>WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) \u2014 \u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=z3JE0KfO-yuOwFmI-5DStEGbrUGbWwdKw7PHbTt7OE1FI-cfZ5HLBAuxNyqY5CV9e__bFfqHSGEh5wrxLImqVP3e3b2hsljy3FZmYO1Ub6kKzsXevvjKgWPQvS0SMqzs4IaItU0bC9ez67qhHPP1WpzBWgrFrCahepF_JAmXcyGcNxtF-PoVoEDRfk08KQRjdppQPHDNPu77AsVcLp4kQ_KmAdgOKyotFjQS1X2uwq0yXKY_RkbBY3DpWRCL2NInvffkZ2iVGBPlnpUiel9eIw==\" target=\"_blank\" rel=\"noreferrer noopener\">Apellis Pharmaceuticals<\/a>,\u00a0Inc. (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<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<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>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) \u2014 \u00a0Apellis Pharmaceuticals,\u00a0Inc. (Nasdaq: APLS), a global biopharmaceutical company<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[103],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) - SFJ Pharmaceuticals<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sfj-pharma.com\/apellis-reports-positive-top-line-results-from-phase-3-head-to-head-study-of-pegcetacoplan-apl-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) - SFJ Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) \u2014 \u00a0Apellis Pharmaceuticals,\u00a0Inc. 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