{"id":52326,"date":"2025-12-31T14:05:29","date_gmt":"2025-12-31T06:05:29","guid":{"rendered":"https:\/\/flcube.com\/?p=52326"},"modified":"2025-12-31T14:05:30","modified_gmt":"2025-12-31T06:05:30","slug":"sirius-therapeutics-doses-first-phase-ii-patient-for-srsd216-sirna-hyperlipoproteinemia-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52326","title":{"rendered":"Sirius Therapeutics Doses First Phase II Patient for SRSD216 siRNA Hyperlipoproteinemia Therapy"},"content":{"rendered":"\n<p><strong>Sirius Therapeutics<\/strong> announced that the <strong>first patient has been dosed<\/strong> in a <strong>Phase\u202fII clinical trial<\/strong> of <strong>SRSD216<\/strong>, a novel <strong>small interfering RNA (siRNA) therapy<\/strong> targeting elevated <strong>lipoprotein(a)<\/strong> levels (hyperlipoproteinemia). The drug demonstrated up to <strong>95% reduction<\/strong> in lipoprotein(a) in Phase\u202fI interim data with effects lasting at least <strong>12 weeks<\/strong> after a single subcutaneous dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-milestone\">Clinical Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Product<\/strong><\/td><td>SRSD216 (siRNA therapy)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Sirius Therapeutics<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>LPA gene silencing, reducing apolipoprotein(a) production<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Hyperlipoproteinemia (elevated lipoprotein(a))<\/td><\/tr><tr><td><strong>Trial<\/strong><\/td><td>Phase\u202fII, first patient dosed (31\u202fDec\u202f2025)<\/td><\/tr><tr><td><strong>Phase\u202fI Interim Data<\/strong><\/td><td>Up to 95% lipoprotein(a) reduction at 3 months, duration \u226512 weeks<\/td><\/tr><tr><td><strong>Safety<\/strong><\/td><td>Favorable profile, no clinically significant risks observed<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mechanism-of-action-amp-differentiation\">Mechanism of Action &amp; Differentiation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target<\/strong>: <strong>LPA gene<\/strong> encoding apolipoprotein(a), the key component of lipoprotein(a) particles<\/li>\n\n\n\n<li><strong>Delivery<\/strong>: <strong>Subcutaneous injection<\/strong> with proprietary GalNAc conjugation for liver\u2011specific uptake<\/li>\n\n\n\n<li><strong>Duration<\/strong>: <strong>Single dose<\/strong> maintains efficacy for \u226512 weeks, supporting <strong>quarterly or less frequent<\/strong> dosing<\/li>\n\n\n\n<li><strong>Selectivity<\/strong>: High target specificity with minimal off\u2011target effects in preclinical models<\/li>\n\n\n\n<li><strong>Competitive Edge<\/strong>: Potentially <strong>longer\u2011lasting<\/strong> than antisense alternatives; <strong>first\u2011in\u2011class siRNA<\/strong> in China for Lp(a) reduction<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-pathway\">Clinical Development Pathway<\/h2>\n\n\n\n<p><strong>Phase\u202fI Study<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ongoing follow\u2011up of dosed participants<\/li>\n\n\n\n<li>Primary completion expected <strong>Q2\u202f2026<\/strong><\/li>\n\n\n\n<li>Data supports advancement to Phase\u202fII without dose\u2011limiting toxicities<\/li>\n<\/ul>\n\n\n\n<p><strong>Phase\u202fII Trial Design<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Population<\/strong>: ~120 patients with baseline lipoprotein(a) \u2265125\u202fnmol\/L and elevated cardiovascular risk<\/li>\n\n\n\n<li><strong>Primary Endpoint<\/strong>: Percent change in lipoprotein(a) from baseline to Week\u202f24<\/li>\n\n\n\n<li><strong>Secondary Endpoints<\/strong>: Time\u2011averaged reduction, safety, LDL\u2011C changes, inflammatory markers<\/li>\n\n\n\n<li><strong>Sites<\/strong>: 15 centers across China, with potential US\/EU expansion pending Phase\u202fII data<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity\">Market Opportunity<\/h2>\n\n\n\n<p><strong>Hyperlipoproteinemia(a) Burden<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Global prevalence<\/strong>: ~20\u201130% of population have elevated lipoprotein(a) (>125\u202fnmol\/L)<\/li>\n\n\n\n<li><strong>China patients<\/strong>: <strong>>200 million<\/strong> individuals with elevated Lp(a), independent cardiovascular risk factor<\/li>\n\n\n\n<li><strong>Unmet Need<\/strong>: <strong>No approved therapies<\/strong> specifically for Lp(a) reduction in China; statins and PCSK9 inhibitors have minimal effect<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2027E<\/th><th>2029E<\/th><th>2031E<\/th><\/tr><\/thead><tbody><tr><td><strong>Addressable patients (China)<\/strong><\/td><td>50\u202fmillion<\/td><td>60\u202fmillion<\/td><td>70\u202fmillion<\/td><\/tr><tr><td><strong>Peak penetration<\/strong><\/td><td>2%<\/td><td>5%<\/td><td>8%<\/td><\/tr><tr><td><strong>Annual therapy cost (\u00a5)<\/strong><\/td><td>\u00a545,000<\/td><td>\u00a538,000 (post\u2011NRDL)<\/td><td>\u00a532,000<\/td><\/tr><tr><td><strong>China market potential<\/strong><\/td><td>\u00a545\u202fbillion<\/td><td>\u00a5114\u202fbillion<\/td><td>\u00a5179\u202fbillion (US$6\u201125\u202fbillion)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug<\/th><th>Company<\/th><th>Mechanism<\/th><th>Stage<\/th><th>Key Differentiator<\/th><\/tr><\/thead><tbody><tr><td><strong>SRSD216<\/strong><\/td><td><strong>Sirius Therapeutics<\/strong><\/td><td><strong>siRNA (LPA)<\/strong><\/td><td><strong>Phase\u202fII<\/strong><\/td><td><strong>95% reduction, \u226512\u2011week duration<\/strong><\/td><\/tr><tr><td>Pelacarsen<\/td><td>Novartis\/Ionis<\/td><td>Antisense oligonucleotide<\/td><td>Phase\u202fIII (Lp(a)HORIZON)<\/td><td>Monthly injections, ~80\u201190% reduction<\/td><\/tr><tr><td>Olpasiran<\/td><td>Amgen<\/td><td>siRNA (LPA)<\/td><td>Phase\u202fIII (OCEAN(a)-DOSE)<\/td><td>Quarterly dosing, ~90% reduction<\/td><\/tr><tr><td>Lepodisiran<\/td><td>Eli Lilly<\/td><td>siRNA (LPA)<\/td><td>Phase\u202fII<\/td><td>Longer\u2011acting, early data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Strategic Position<\/strong>: SRSD216\u2019s <strong>Phase\u202fI durability data<\/strong> (\u226512 weeks) suggests potential for <strong>quarterly or bi\u2011annual<\/strong> dosing, offering <strong>competitive advantage<\/strong> over monthly antisense therapies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-company-background-amp-financial-position\">Company Background &amp; Financial Position<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Founded<\/strong>: 2021 by world\u2011class management team and top\u2011tier investors<\/li>\n\n\n\n<li><strong>Operations<\/strong>: <strong>Innovation R&amp;D center in United States<\/strong>, <strong>translational medicine center in China<\/strong><\/li>\n\n\n\n<li><strong>Funding<\/strong>: <strong>Nearly USD\u202f150\u202fmillion<\/strong> raised cumulatively<\/li>\n\n\n\n<li><strong>Investor Syndicate<\/strong>: <strong>OrbiMed, Creacion Ventures, Hankang Capital, Delos Capital, BioTrack Capital<\/strong><\/li>\n\n\n\n<li><strong>Runway<\/strong>: Funding supports operations through <strong>Phase\u202fII completion and Phase\u202fIII initiation<\/strong> (2027)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-timeline-amp-financial-outlook\">Development Timeline &amp; Financial Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Target Date<\/th><th>Investment (USD)<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase\u202fII interim data<\/strong><\/td><td>Q4\u202f2026<\/td><td>$25\u202fmillion<\/td><\/tr><tr><td><strong>Phase\u202fII completion<\/strong><\/td><td>Q2\u202f2027<\/td><td>$40\u202fmillion<\/td><\/tr><tr><td><strong>Phase\u202fIII initiation<\/strong><\/td><td>H2\u202f2027<\/td><td>$120\u202fmillion<\/td><\/tr><tr><td><strong>NDA filing<\/strong><\/td><td>2029<\/td><td>$80\u202fmillion<\/td><\/tr><tr><td><strong>Potential approval<\/strong><\/td><td>2030<\/td><td>\u2013<\/td><\/tr><tr><td><strong>Peak sales potential (global)<\/strong><\/td><td>2032+<\/td><td><strong>$3\u20115\u202fbillion<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><\/p>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding SRSD216\u2019s clinical development, market potential, and competitive positioning. Actual results may differ materially due to clinical trial outcomes, regulatory decisions, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sirius Therapeutics announced that the first patient has been dosed in a Phase\u202fII clinical trial&#8230;<\/p>\n","protected":false},"author":1,"featured_media":52329,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[62,69,64,1962],"class_list":["post-52326","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-cvd","tag-rnai-aso","tag-sirius-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sirius Therapeutics Doses First Phase II Patient for SRSD216 siRNA Hyperlipoproteinemia Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sirius Therapeutics announced that the first patient has been dosed in a Phase\u202fII clinical trial of SRSD216, a novel small interfering RNA (siRNA) therapy targeting elevated lipoprotein(a) levels (hyperlipoproteinemia). 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