{"id":18846,"date":"2023-05-24T02:24:00","date_gmt":"2023-05-24T02:24:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4108297_AE08297_0"},"modified":"2023-05-24T02:24:00","modified_gmt":"2023-05-24T02:24:00","slug":"allgenesis-announces-encouraging-preliminary-safety-and-efficacy-data-from-the-ag-73305-phase-2a-trial-for-the-treatment-of-diabetic-macular-edema","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=18846","title":{"rendered":"Allgenesis Announces Encouraging Preliminary Safety and Efficacy Data from the AG-73305 Phase 2a Trial for the Treatment of Diabetic Macular Edema"},"content":{"rendered":"<div id=\"dvContent\" readability=\"99.756157635468\">\n<ul type=\"disc\">\n<li>AG-73305 was found to be safe and tolerable with no severe adverse effects (SAEs) after a single intravitreal injection of 0.5 mg and 1 mg in DME patients.<\/li>\n<li>AG-73305 showed median improvements in Best Corrected Visual Accuity (BCVA) of 8.5 ETDRS letters with median Central Subfield Thickness (CST) improvements of -110 microns from baseline across the 2 doses.<\/li>\n<li>The efficacious effects in all 6 patients lasted between 12 and 24 weeks after a single injection of AG-73305.<\/li>\n<\/ul>\n<p><span class=\"xn-location\">TAIPEI<\/span>, <span class=\"xn-chron\">May 24, 2023<\/span> \/PRNewswire\/ &#8212;&nbsp;Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, announces exciting preliminary data from the two initial cohorts of the on-going AG-77305 FIH Phase 2a clinical trial for the treatment of Diabetic Macular Edema (DME) in the US. In addition, Allgenesis completed <a href=\"https:\/\/www.allgenesis.com\/2023\/04\/18\/allgenesis-announces-last-patient-enrolled-in-the-phase-2a-trial-evaluating-the-safety-and-efficacy-of-ag-73305-in-diabetic-macular-edema-dme-patients\/\" target=\"_blank\" rel=\"nofollow noopener\">dosing of the last patient<\/a>&nbsp;in <span class=\"xn-chron\">April 2023<\/span>, and anticipates the release of the final topline data, including data from the latter two cohorts (the 2 and 4 mg cohorts), in 4Q23. &nbsp;<\/p>\n<p>Preliminary data from the 0.5 mg (n=3) and 1 mg (n=3) cohorts demonstrated that AG-73305 was safe and tolerable after a single intravitreal injection.&nbsp; There were no dose-limiting toxicities and&nbsp;no SAEs related to AG-73305 in patients. The 0.5 mg cohort showed median improvement in BCVA of +8 ETDRS letters with CST reduction of -57.9 microns. The 1 mg AG-73305 cohort showed median improvement in BCVA of +14 ETDRS letters and CST reductions of -145 microns. All 6 patients responded to the treatment with efficacy lasting between 12 and 24&nbsp;weeks after a single injection.<\/p>\n<p>&#8220;We are thrilled to share this exciting preliminary data and anticipate continued improvements as we treat patients with higher doses of AG-73305.&#8221; said Madhu Cherukury, Ph.D., DABT., CEO of Allgenesis. &#8220;The current data for AG-73305 supports our hypothesis that blocking multiple pathways in the disease state can provide additional benefits to DME patients in the form of BCVA gains and durability.&#8221;<\/p>\n<p>&#8220;We are very encouraged by the safety and efficacy outcomes after just one intravitreal injection with the low doses&#8221;, said <span class=\"xn-person\">Sunil Patel<\/span> MD, PhD., Chief Medical Officer. &#8220;AG-73305, through its novel mechanism of action, has the potential to be a disease modifying therapy for retinal disease.&#8221;<\/p>\n<p>&#8220;Given the positive data that we are seeing from the open label study, we are forging ahead with our plans to initiate a Ph2b study in DME patients.&#8221; said Dr. Cherukury.<\/p>\n<p>In <span class=\"xn-chron\">September 2021<\/span>, Allgenesis announced it entered into a licensing agreement with AffaMed Therapeutics for the development and commercialization of AG-73305 in <span class=\"xn-location\">Greater China<\/span>, <span class=\"xn-location\">South Korea<\/span>, and multiple ASEAN markets.<\/p>\n<p>For additional inquiries regarding collaboration and partnering opportunities related to AG-73305, please contact <span class=\"xn-person\">Jack Chang<\/span> or <span class=\"xn-person\">Sandy Lai<\/span> at <a href=\"mailto:info@allgenesis.com\" target=\"_blank\" rel=\"nofollow noopener\">info@allgenesis.com<\/a> for more information.<\/p>\n<p><b>About AG-73305<\/b><\/p>\n<p>AG-73305 is a humanized, bi-specific Fc-fusion protein designed to simultaneously block VEGFs and integrins for the treatment of DME, nAMD, RVO, and other retinal diseases. AG-73305 contains a VEGF-trap and a disintegrin that blocks various key integrin receptors. AG-73305 has the potential to treat both anti-VEGF responders and non-responders.<\/p>\n<p><b>About Allgenesis Biotherapeutics Inc.<\/b><\/p>\n<p>Allgenesis is a clinical-stage biopharmaceutical company headquartered in <span class=\"xn-location\">Taipei, Taiwan<\/span>. The company is focused on research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, nAMD, and other retinal diseases such as RVO, and AG-80308 for Dry Eye Disease.<\/p>\n<\/p><\/div>\n<p>Source: Allgenesis Biotherapeutics Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AG-73305 was found to be safe and tolerable with no severe adverse effects (SAEs) after a single intravitreal injection of 0.5 mg and 1 mg in DME patients. AG-73305 showed median improvements in Best Corrected Visual Accuity (BCVA) of 8.5 ETDRS letters with median Central Subfield Thickness (CST) improvements of -110 microns from baseline across [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-18846","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Allgenesis Announces Encouraging Preliminary Safety and Efficacy Data from the AG-73305 Phase 2a Trial for the Treatment of Diabetic Macular Edema - My Blog<\/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:\/\/transmediavictoria.net.au\/?p=18846\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Allgenesis Announces Encouraging Preliminary Safety and Efficacy Data from the AG-73305 Phase 2a Trial for the Treatment of Diabetic Macular Edema - My Blog\" \/>\n<meta property=\"og:description\" content=\"AG-73305 was found to be safe and tolerable with no severe adverse effects (SAEs) after a single intravitreal injection of 0.5 mg and 1 mg in DME patients. 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