{"id":35,"date":"2023-08-28T21:43:03","date_gmt":"2023-08-28T21:43:03","guid":{"rendered":"https:\/\/onltherapeutics.com\/test\/?page_id=35"},"modified":"2025-10-28T11:32:52","modified_gmt":"2025-10-28T11:32:52","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/onltherapeutics.com\/test\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"\n<div class=\"wp-block-cover alignfull has-parallax wp-duotone-midnight\" style=\"border-radius:50px;margin-top:0;margin-bottom:0;padding-left:0;min-height:180px;aspect-ratio:unset;\"><div role=\"img\" aria-label=\"ONL Clinical Trials\" class=\"wp-block-cover__image-background wp-image-2098 has-parallax\" style=\"background-position:50% 50%;background-image:url(https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/Galaxy_Eye_Image_Sized.png)\"><\/div><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim-0 has-background-dim\" style=\"background-color:#61636d\"><\/span><div class=\"wp-block-cover__inner-container has-global-padding is-layout-constrained wp-container-core-cover-is-layout-0c501ecd wp-block-cover-is-layout-constrained\">\n<p class=\"has-base-color has-text-color has-link-color wp-elements-56554fa4c4f0fffedf14ff3e83a6c206\" style=\"padding-left:var(--wp--preset--spacing--40);font-size:clamp(2.2rem, 2.2rem + ((1vw - 0.2rem) * 4.235), 4rem);font-style:normal;font-weight:700;text-transform:capitalize\">Clinical Trials<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns has-tertiary-background-color has-background is-layout-flex wp-container-core-columns-is-layout-76a62f61 wp-block-columns-is-layout-flex\" style=\"border-radius:30px;padding-top:30px;padding-right:var(--wp--preset--spacing--30);padding-bottom:30px;padding-left:var(--wp--preset--spacing--30)\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"padding-top:0px;padding-bottom:0px\">\n<h3 class=\"wp-block-heading has-tertiary-background-color has-background\" style=\"padding-top:0;padding-right:0;padding-bottom:0;padding-left:0;font-size:clamp(22.041px, 1.378rem + ((1vw - 3.2px) * 2.053), 36px);letter-spacing:1px;text-transform:none\">ONL is leveraging its innovative neuroprotection platform technology to develop new treatments for multiple, vision-threatening retinal diseases<\/h3>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.882), 20px);\">ONL\u2019s lead therapeutic candidate, xelafaslatide (formerly ONL1204), is a first-in-class small peptide that effectively inhibits the Fas receptor, thus blocking the activation of the Fas pathway and the related immune signaling which results in the death of key retinal cells and loss of vision.<\/p>\n\n\n\n<p style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.882), 20px);\">Xelafaslatide is designated an investigational drug and is not approved for commercial use. As such, the information on this page was created for scientific exchange with Healthcare Professionals only.<\/p>\n\n\n\n<p style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.882), 20px);\">Across all completed clinical studies to date, xelafaslatide has been found to be generally safe and well tolerated, under the planned oversight and guidance of safety review committees.<\/p>\n\n\n\n<p style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.882), 20px);\"><strong>Learn more about our clinical trials below:<\/strong><\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns alignwide has-tertiary-background-color has-background is-layout-flex wp-container-core-columns-is-layout-07b7b7eb wp-block-columns-is-layout-flex\" style=\"border-radius:30px;border-top-style:none;border-top-width:0px;border-right-color:var(--wp--preset--color--custom-blue);border-right-width:10px;border-bottom-style:none;border-bottom-width:0px;border-left-color:var(--wp--preset--color--custom-blue);border-left-width:10px;padding-top:0;padding-right:0;padding-bottom:0;padding-left:0\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-container-core-column-is-layout-82062dd9 wp-block-column-is-layout-flow\" style=\"border-top-left-radius:25px;border-top-right-radius:25px;border-bottom-left-radius:25px;padding-top:0;padding-right:var(--wp--preset--spacing--40);padding-bottom:0;padding-left:var(--wp--preset--spacing--40);flex-basis:66.66%\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8b2cf334 wp-block-columns-is-layout-flex\" id=\"amd\" style=\"border-radius:21px;padding-top:40px\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"35\" height=\"20\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/Galaxy_Logo.svg\" alt=\"\" class=\"wp-image-2108\" style=\"width:180px;height:auto\"\/><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-style:none;border-width:0px;background-color:#bacadc;flex-basis:20%\">\n<p class=\"has-text-align-center has-tertiary-background-color has-background\" style=\"border-top-color:#bacadc;border-top-width:2px;border-right-style:none;border-right-width:0px;border-bottom-color:#bacadc;border-bottom-width:2px;border-left-style:none;border-left-width:0px;padding-right:0;padding-left:0;font-size:14px\">Dry AMD\/GA<\/p>\n<\/div>\n<\/div>\n\n\n\n<p style=\"font-style:normal;font-weight:700\">A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 (Xelafaslatide) in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD)<\/p>\n\n\n\n<p class=\"has-text-align-left\">The purpose of this study is to collect efficacy and safety information across 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies (once every 12 weeks or 24 weeks) in patients with GA associated with AMD.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-custom-dark-blue-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-radius:24px;border-top-style:none;border-top-width:0px;border-right-style:none;border-right-width:0px;border-bottom-style:none;border-bottom-width:0px;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);flex-basis:33.33%\">\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-c4d2f5f37fef339612d466d439e208ef\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);font-style:normal;font-weight:400;letter-spacing:0px\"><img loading=\"lazy\" decoding=\"async\" width=\"13\" height=\"14\" class=\"wp-image-2103\" style=\"width: 13px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/bright_Green_Dot.png\" alt=\"\"> ACTIVE<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-d8744f97aad4961377fc5eaefa7ba60c\" style=\"padding-top:20px;padding-bottom:20px;font-style:normal;font-weight:400\">NCT06659445<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-cfa3526ea91a6e88a0615071db15209e\" style=\"font-style:normal;font-weight:400\">Phase 2<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-90711f0c57cbefca294b40a4b30b5236\" style=\"padding-top:20px;padding-bottom:9px;font-style:normal;font-weight:400\">Intravitreal (IVT) Injection ONL1204:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column has-global-padding is-content-justification-left is-layout-constrained wp-container-core-column-is-layout-09686e84 wp-block-column-is-layout-constrained\" style=\"padding-top:0;padding-right:0;padding-bottom:0;padding-left:0\">\n<ul style=\"padding-top:0;padding-right:24px;padding-bottom:0;padding-left:24px\" class=\"wp-block-list has-base-color has-custom-dark-blue-background-color has-text-color has-background has-link-color wp-elements-a1abc867f64b53f0a8a9a986adebc310\">\n<li style=\"padding-top:0;padding-bottom:0;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\"><span style=\"font-size: var(--wp--preset--font-size--medium); letter-spacing: 0px;\">Dosing: Injection every 12 weeks or 24 weeks for 72 weeks<\/span><\/li>\n\n\n\n<li style=\"padding-top:0;padding-bottom:0;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Doses: 100 \u00b5g (50 \u00b5l), 200 \u00b5g (100 \u00b5l)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-098cc607 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-base-color has-custom-blue-background-color has-text-color has-background has-link-color has-custom-font-size wp-element-button\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT06659445\" style=\"border-radius:11px;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\" target=\"_blank\" rel=\"noreferrer noopener\">View Study at ClinicalTrials.gov <img loading=\"lazy\" decoding=\"async\" width=\"18\" height=\"18\" class=\"wp-image-2126\" style=\"width: 18px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/arrow-up-right-from-square-solid_white.svg\" alt=\"\"><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:47px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:70px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns alignwide has-tertiary-background-color has-background is-layout-flex wp-container-core-columns-is-layout-07b7b7eb wp-block-columns-is-layout-flex\" style=\"border-radius:30px;border-top-style:none;border-top-width:0px;border-right-color:var(--wp--preset--color--custom-blue);border-right-width:10px;border-bottom-style:none;border-bottom-width:0px;border-left-color:var(--wp--preset--color--custom-blue);border-left-width:10px;padding-top:0;padding-right:0;padding-bottom:0;padding-left:0\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-top-left-radius:25px;border-top-right-radius:25px;border-bottom-left-radius:25px;padding-top:0;padding-right:var(--wp--preset--spacing--40);padding-bottom:0;padding-left:var(--wp--preset--spacing--40);flex-basis:66.66%\">\n<div style=\"height:40px\" aria-hidden=\"true\" id=\"amd\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"164\" height=\"76\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/ONL1204_LOGO.svg\" alt=\"\" class=\"wp-image-2104\" style=\"width:159px;height:auto\"\/><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"background-color:#bacadc;flex-basis:20%\">\n<p class=\"has-text-align-center has-tertiary-background-color has-background\" style=\"border-top-color:#bacadc;border-top-width:2px;border-bottom-color:#bacadc;border-bottom-width:2px;padding-right:0;padding-left:0;font-size:14px\">Dry AMD\/GA<\/p>\n<\/div>\n<\/div>\n\n\n\n<p style=\"font-style:normal;font-weight:700\">A Phase 1b Multicenter, Randomized, Controlled, Multi-dose Study of the Safety and Tolerability of ONL1204 (Xelafaslatide) Ophthalmic Solution in Patients with Geographic Atrophy (GA) Associated with Age-related Macular Degeneration (AMD)<\/p>\n\n\n\n<p class=\"has-text-align-left\">The purpose of this study was to evaluate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with AMD.<\/p>\n\n\n\n<p class=\"has-text-align-left\">ONL1204 was generally safe and well tolerated in this study. Data assessments showed efficacy signals observed after 6 months, with ONL1204-treated eyes slowing GA lesion growth compared to untreated eyes.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-custom-dark-blue-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-radius:24px;border-top-style:none;border-top-width:0px;border-right-style:none;border-right-width:0px;border-bottom-style:none;border-bottom-width:0px;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);flex-basis:33.33%\">\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-da65a4807195c86643d519699f40eb8f\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);font-style:normal;font-weight:400;letter-spacing:0px\"><img loading=\"lazy\" decoding=\"async\" width=\"13\" height=\"14\" class=\"wp-image-2102\" style=\"width: 13px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/blue_dot.png\" alt=\"\"> COMPLETED<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-e370d4fa4ff6a3cb287688091144b9ec\" style=\"padding-top:20px;padding-bottom:0;font-style:normal;font-weight:400\">NCT04744662<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-4284fa28606a2f8bc7c345d7ec78717e\" style=\"padding-top:20px;padding-bottom:9px;font-style:normal;font-weight:400\">Phase 1b<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-90711f0c57cbefca294b40a4b30b5236\" style=\"padding-top:20px;padding-bottom:9px;font-style:normal;font-weight:400\">Intravitreal (IVT) Injection ONL1204:<\/p>\n\n\n\n<ul style=\"padding-right:21px;padding-left:21px\" class=\"wp-block-list has-base-color has-text-color has-link-color wp-elements-7a37fbde8c5ef1c337686ae9708a1b6a\">\n<li style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Dosing:\n<ul class=\"wp-block-list\">\n<li>Component 1: Single injection with patients followed for 6 months<\/li>\n\n\n\n<li>Component 2: 6-month natural history period followed by 6-month treatment period with two injections delivered 12 weeks apart<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<ul style=\"padding-left:18px\" class=\"wp-block-list has-base-color has-text-color\">\n<li class=\"has-base-color has-text-color has-link-color wp-elements-e5e38d72e36b9f3f8651ae540a4eb50f\" style=\"margin-right:0;margin-left:0;padding-right:0;padding-left:0;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Doses: 50 \u00b5g (100 \u00b5l), 200 \u00b5g (100 \u00b5l)<\/li>\n<\/ul>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-098cc607 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-base-color has-custom-blue-background-color has-text-color has-background has-link-color has-custom-font-size wp-element-button\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT04744662\" style=\"border-radius:11px;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\" target=\"_blank\" rel=\"noreferrer noopener\">View Study at ClinicalTrials.gov <img loading=\"lazy\" decoding=\"async\" width=\"18\" height=\"18\" class=\"wp-image-2126\" style=\"width: 18px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/arrow-up-right-from-square-solid_white.svg\" alt=\"\"><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:47px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:70px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns alignwide has-tertiary-background-color has-background is-layout-flex wp-container-core-columns-is-layout-4920901c wp-block-columns-is-layout-flex\" style=\"border-radius:30px;border-top-style:none;border-top-width:0px;border-right-color:var(--wp--preset--color--custom-blue);border-right-width:10px;border-bottom-style:none;border-bottom-width:0px;border-left-color:var(--wp--preset--color--custom-blue);border-left-width:10px;margin-bottom:0;padding-top:0;padding-right:0;padding-bottom:0;padding-left:0\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-top-left-radius:25px;border-top-right-radius:25px;border-bottom-left-radius:25px;padding-top:0;padding-right:var(--wp--preset--spacing--40);padding-bottom:0;padding-left:var(--wp--preset--spacing--40);flex-basis:66.66%\">\n<div style=\"height:40px\" aria-hidden=\"true\" id=\"glaucoma\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"164\" height=\"76\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/ONL1204_LOGO.svg\" alt=\"\" class=\"wp-image-2104\" style=\"width:164px;height:auto\"\/><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"padding-top:0;padding-right:9px;padding-bottom:0;padding-left:9px;flex-basis:40%\">\n<p class=\"has-text-align-center has-tertiary-background-color has-background\" style=\"border-top-color:#bacadc;border-top-width:2px;border-bottom-color:#bacadc;border-bottom-width:2px;font-size:14px\">Progressive Open Angle Glaucoma<\/p>\n<\/div>\n<\/div>\n\n\n\n<p style=\"font-style:normal;font-weight:700\">A Phase 1b Multicenter, Randomized, Single-Masked, Sham-Controlled Study of the Safety and Tolerability of ONL1204 Ophthalmic Solution (Xelafaslatide) in Patients with Progressing Open Angle Glaucoma<\/p>\n\n\n\n<p class=\"has-text-align-left\">The purpose of this study was to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma.<\/p>\n\n\n\n<p class=\"has-text-align-left\">ONL1204 was generally safe and well tolerated in this study. Data assessments demonstrated that ONL1204-treated eyes showed sustained increases in retinal nerve fiber layer thickness and improved or stabilized visual fields.<\/p>\n\n\n\n<p>These initial data points demonstrate the potential for ONL1204 as a neuroprotection treatment for progressing open-angle glaucoma patients.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-custom-dark-blue-background-color has-background has-global-padding is-layout-constrained wp-container-core-column-is-layout-ff778368 wp-block-column-is-layout-constrained\" style=\"border-radius:24px;border-top-style:none;border-top-width:0px;border-right-style:none;border-right-width:0px;border-bottom-style:none;border-bottom-width:0px;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);flex-basis:33.33%\">\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-2d90b4b483f04c8cc2cbee9821f4fdb2\" style=\"margin-right:0;margin-left:0;padding-right:0;padding-left:0;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);font-style:normal;font-weight:400;letter-spacing:0px\"><img loading=\"lazy\" decoding=\"async\" width=\"13\" height=\"14\" class=\"wp-image-2102\" style=\"width: 13px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/blue_dot.png\" alt=\"\"> COMPLETED<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-a42830e75b61b655d2419bf49a2aaa2a\" style=\"padding-top:20px;font-style:normal;font-weight:400\">NCT05160805<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-9ddc3dd28c677822d0040e7de8724aa0\" style=\"font-style:normal;font-weight:400\">Phase 1b<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-f43a2f9d0b08fbec74ed7b120e726364\" style=\"font-style:normal;font-weight:400\">Intravitreal (IVT) Injection ONL1204:<\/p>\n\n\n\n<div class=\"wp-block-columns has-base-color has-custom-dark-blue-background-color has-text-color has-background has-link-color wp-elements-dddfad19c45124263762534310b725ec is-layout-flex wp-container-core-columns-is-layout-5a98498f wp-block-columns-is-layout-flex\" style=\"padding-top:0;padding-right:19px;padding-bottom:0;padding-left:19px\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul style=\"padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px\" class=\"wp-block-list has-base-color has-custom-dark-blue-background-color has-text-color has-background\">\n<li style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Dosing: Two injections, 90 days apart followed by a 180-day wash-out<\/li>\n\n\n\n<li style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Doses: 50 \u00b5g (100 \u00b5l), 100 \u00b5g (50 \u00b5l)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:166px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-098cc607 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-base-color has-custom-blue-background-color has-text-color has-background has-link-color has-custom-font-size wp-element-button\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT05160805\" style=\"border-radius:11px;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\" target=\"_blank\" rel=\"noreferrer noopener\">View Study at ClinicalTrials.gov <img loading=\"lazy\" decoding=\"async\" width=\"18\" height=\"18\" class=\"wp-image-2126\" style=\"width: 18px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/arrow-up-right-from-square-solid_white.svg\" alt=\"\"><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:47px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:70px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns alignwide has-tertiary-background-color has-background is-layout-flex wp-container-core-columns-is-layout-4920901c wp-block-columns-is-layout-flex\" style=\"border-radius:30px;border-top-style:none;border-top-width:0px;border-right-color:var(--wp--preset--color--custom-blue);border-right-width:10px;border-bottom-style:none;border-bottom-width:0px;border-left-color:var(--wp--preset--color--custom-blue);border-left-width:10px;margin-bottom:0;padding-top:0;padding-right:0;padding-bottom:0;padding-left:0\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-top-left-radius:25px;border-top-right-radius:25px;border-bottom-left-radius:25px;padding-top:0;padding-right:var(--wp--preset--spacing--40);padding-bottom:0;padding-left:var(--wp--preset--spacing--40);flex-basis:66.66%\">\n<div style=\"height:40px\" aria-hidden=\"true\" id=\"rrd\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"164\" height=\"76\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/ONL1204_LOGO.svg\" alt=\"\" class=\"wp-image-2104\" style=\"width:164px;height:auto\"\/><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"padding-top:0;padding-right:9px;padding-bottom:0;padding-left:9px;flex-basis:70%\">\n<p class=\"has-text-align-center\" style=\"border-top-color:#bacadc;border-top-width:2px;border-bottom-color:#bacadc;border-bottom-width:2px;font-size:14px\">Rhegmatogenous Retinal Detachment (Macula-Off)<\/p>\n<\/div>\n<\/div>\n\n\n\n<p style=\"font-style:normal;font-weight:700\">A Phase 2, Randomized, Sham-Controlled, Single-Masked, Dose-Ranging, Multi-Center Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution (Xelafaslatide) in Subjects with Macula-off Rhegmatogenous Retinal Detachment<\/p>\n\n\n\n<p class=\"has-text-align-left\">The goal of this Phase 2 clinical trial was to learn about ONL1204 Ophthalmic Solution in terms of safety and how well the drug works in patients that have a macula-off (central point of vision) rhegmatogenous retinal detachment (RRD).<\/p>\n\n\n\n<p class=\"has-text-align-left\">While the study overall did not meet the primary endpoint, ONL1204 did show benefit in patients at highest risk for vision loss, consistent with a potential neuroprotective effect seen across all clinical studies to date.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-custom-dark-blue-background-color has-background has-global-padding is-layout-constrained wp-container-core-column-is-layout-ff778368 wp-block-column-is-layout-constrained\" style=\"border-radius:24px;border-top-style:none;border-top-width:0px;border-right-style:none;border-right-width:0px;border-bottom-style:none;border-bottom-width:0px;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);flex-basis:33.33%\">\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-da65a4807195c86643d519699f40eb8f\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);font-style:normal;font-weight:400;letter-spacing:0px\"><img loading=\"lazy\" decoding=\"async\" width=\"13\" height=\"14\" class=\"wp-image-2102\" style=\"width: 13px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/blue_dot.png\" alt=\"\"> COMPLETED<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-b82608b71d7e90b73f90b3041ea48514\" style=\"font-style:normal;font-weight:400\">NCT05730218<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-cfa3526ea91a6e88a0615071db15209e\" style=\"font-style:normal;font-weight:400\">Phase 2<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-f43a2f9d0b08fbec74ed7b120e726364\" style=\"font-style:normal;font-weight:400\">Intravitreal (IVT) Injection ONL1204:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul style=\"padding-top:0;padding-right:22px;padding-bottom:0;padding-left:22px\" class=\"wp-block-list has-base-color has-custom-dark-blue-background-color has-text-color has-background has-link-color wp-elements-71b73e2e70ae45f7cc677b6484fca845\">\n<li class=\"has-base-color has-text-color has-link-color wp-elements-a69117887a0159895a392569f1e4a3f8\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Dosing: Once at randomization<\/li>\n\n\n\n<li class=\"has-base-color has-text-color has-link-color wp-elements-846fdafdc26cdf9bc9349bc2579044b0\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Doses: 50 \u00b5g (100 \u00b5l), 200 \u00b5g (100 \u00b5l)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:186px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-098cc607 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-base-color has-custom-blue-background-color has-text-color has-background has-link-color has-custom-font-size wp-element-button\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT05730218\" style=\"border-radius:11px;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\" target=\"_blank\" rel=\"noreferrer noopener\">View Study at ClinicalTrials.gov <img loading=\"lazy\" decoding=\"async\" width=\"18\" height=\"18\" class=\"wp-image-2126\" style=\"width: 18px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/arrow-up-right-from-square-solid_white.svg\" alt=\"\"><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:70px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns alignwide has-tertiary-background-color has-background is-layout-flex wp-container-core-columns-is-layout-4920901c wp-block-columns-is-layout-flex\" style=\"border-radius:30px;border-top-style:none;border-top-width:0px;border-right-color:var(--wp--preset--color--custom-blue);border-right-width:10px;border-bottom-style:none;border-bottom-width:0px;border-left-color:var(--wp--preset--color--custom-blue);border-left-width:10px;margin-bottom:0;padding-top:0;padding-right:0;padding-bottom:0;padding-left:0\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"border-top-left-radius:25px;border-top-right-radius:25px;border-bottom-left-radius:25px;padding-top:0;padding-right:var(--wp--preset--spacing--40);padding-bottom:0;padding-left:var(--wp--preset--spacing--40);flex-basis:66.66%\">\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"164\" height=\"76\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/ONL1204_LOGO.svg\" alt=\"\" class=\"wp-image-2104\" style=\"width:164px;height:auto\"\/><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-tertiary-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"padding-top:0;padding-right:9px;padding-bottom:0;padding-left:9px;flex-basis:70%\">\n<p class=\"has-text-align-center\" style=\"border-top-color:#bacadc;border-top-width:2px;border-bottom-color:#bacadc;border-bottom-width:2px;font-size:14px\">Rhegmatogenous Retinal Detachment (Macula-Off)<\/p>\n<\/div>\n<\/div>\n\n\n\n<p style=\"font-style:normal;font-weight:700\">A Phase 1 Open-Label, Dose Escalation Study to Assess the Safety and Tolerability of Intravitreal ONL1204 (Xelafaslatide) in Patients with Macula-off, Rhegmatogenous Retinal Detachment<\/p>\n\n\n\n<p class=\"has-text-align-left\">The purpose of this study was to evaluate the safety and tolerability of ONL1204 in participants with Macula-off, Rhegmatogenous Retinal Detachment (RRD).<\/p>\n\n\n\n<p class=\"has-text-align-left\">In this study, ONL1204 was generally safe and well tolerated at all evaluated doses when administered as a single IVT injection in patients with macula-off RRD. Several cytokines that were predicted to be Fas-dependent exhibited a trend toward reduction following the administration of ONL1204 Ophthalmic Solution, including MCP-1.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-custom-dark-blue-background-color has-background has-global-padding is-layout-constrained wp-container-core-column-is-layout-ff778368 wp-block-column-is-layout-constrained\" style=\"border-radius:24px;border-top-style:none;border-top-width:0px;border-right-style:none;border-right-width:0px;border-bottom-style:none;border-bottom-width:0px;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);flex-basis:33.33%\">\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-da65a4807195c86643d519699f40eb8f\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);font-style:normal;font-weight:400;letter-spacing:0px\"><img loading=\"lazy\" decoding=\"async\" width=\"13\" height=\"14\" class=\"wp-image-2102\" style=\"width: 13px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/blue_dot.png\" alt=\"\"> COMPLETED<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-f6dd84e46cd2e12973447519819cdc8e\" style=\"font-style:normal;font-weight:400\">NCT03780972<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-c1f81aa575e831c886201150022bbc58\" style=\"font-style:normal;font-weight:400\">Phase 1<\/p>\n\n\n\n<p class=\"has-base-color has-text-color has-link-color wp-elements-1d9f48919f4ca418bef3aa5a19ede219\" style=\"margin-top:0;margin-bottom:0;padding-bottom:7px;font-style:normal;font-weight:400\">Intravitreal (IVT) Injection ONL1204:<\/p>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-center has-base-color has-custom-dark-blue-background-color has-text-color has-background has-link-color wp-elements-802b9a7dec2953ecc71b0db1a4ad4025 is-layout-flex wp-container-core-columns-is-layout-dee106ac wp-block-columns-is-layout-flex\" style=\"padding-top:0;padding-right:0px;padding-bottom:0;padding-left:0px\">\n<div class=\"wp-block-column is-vertically-aligned-center has-base-color has-custom-dark-blue-background-color has-text-color has-background has-link-color wp-elements-9bdcfc2a11789b9084a28cb0abc79ec2 has-global-padding is-content-justification-left is-layout-constrained wp-container-core-column-is-layout-68fcfa73 wp-block-column-is-layout-constrained\" style=\"padding-top:0;padding-right:0;padding-left:0px\">\n<ul style=\"margin-top:0;margin-bottom:0;padding-top:0;padding-right:20px;padding-bottom:0;padding-left:20px\" class=\"wp-block-list\">\n<li class=\"has-base-color has-text-color has-link-color wp-elements-75002abb2916f2d9c6285791df2529e9\" style=\"margin-top:0;margin-bottom:0;padding-top:0;padding-bottom:0;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);font-style:normal;font-weight:400\">Dosing: Once at randomization<\/li>\n\n\n\n<li class=\"has-base-color has-text-color has-link-color wp-elements-cf12cac36b635fa29fdf30b888cd419d\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\">Doses: 25 \u00b5g (50 \u00b5l), 50 \u00b5g (100 \u00b5l), 100 \u00b5g (50 \u00b5l), 200 \u00b5g (100 \u00b5l)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:155px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-098cc607 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-base-color has-custom-blue-background-color has-text-color has-background has-link-color has-custom-font-size wp-element-button\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT03780972\" style=\"border-radius:11px;font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.588), 18px);\" target=\"_blank\" rel=\"noreferrer noopener\">View Study at ClinicalTrials.gov <img loading=\"lazy\" decoding=\"async\" width=\"18\" height=\"18\" class=\"wp-image-2126\" style=\"width: 18px;\" src=\"https:\/\/onltherapeutics.com\/test\/wp-content\/uploads\/2024\/11\/arrow-up-right-from-square-solid_white.svg\" alt=\"\"><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:47px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>ONL is leveraging its innovative neuroprotection platform technology to develop new treatments for multiple, vision-threatening retinal diseases ONL\u2019s lead therapeutic candidate, xelafaslatide (formerly ONL1204), is a first-in-class small peptide that effectively inhibits the Fas receptor, thus blocking the activation of the Fas pathway and the related immune signaling which results in the death of key [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"blank","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-35","page","type-page","status-publish","hentry"],"featured_image_urls_v2":{"full":"","thumbnail":"","medium":"","medium_large":"","large":"","1536x1536":"","2048x2048":"","gform-image-choice-sm":"","gform-image-choice-md":"","gform-image-choice-lg":""},"post_excerpt_stackable_v2":"<p>Clinical Trials ONL is leveraging its innovative neuroprotection platform technology to develop new treatments for multiple, vision-threatening retinal diseases ONL\u2019s lead therapeutic candidate, xelafaslatide (formerly ONL1204), is a first-in-class small peptide that effectively inhibits the Fas receptor, thus blocking the activation of the Fas pathway and the related immune signaling which results in the death of key retinal cells and loss of vision. Xelafaslatide is designated an investigational drug and is not approved for commercial use. As such, the information on this page was created for scientific exchange with Healthcare Professionals only. Across all completed clinical studies to date, xelafaslatide&hellip;<\/p>\n","category_list_v2":"","author_info_v2":{"name":"theo@myriadweb.com","url":"https:\/\/onltherapeutics.com\/test\/author\/theomyriadweb-com\/"},"comments_num_v2":"0 comments","_links":{"self":[{"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/pages\/35","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/comments?post=35"}],"version-history":[{"count":92,"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/pages\/35\/revisions"}],"predecessor-version":[{"id":2550,"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/pages\/35\/revisions\/2550"}],"wp:attachment":[{"href":"https:\/\/onltherapeutics.com\/test\/wp-json\/wp\/v2\/media?parent=35"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}