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[IT뉴스]Elisigen, Presents Positive 52-Week Phase 1/2a Data for NG101 at ARVO 2026

온카뱅크관리자

2026-05-07 14:47:33

<div class="article_view" data-translation-body="true" data-tiara-layer="article_body" data-tiara-action-name="본문이미지확대_클릭"> 
         <section dmcf-sid="PalUZr0HEV">
          <p contents-hash="9f846f5222c03c68f85b61c684e20689f8d7feb4ad8f241bb269f4437af90978" dmcf-pid="QNSu5mpXs2" dmcf-ptype="general"> [Seungkwon kim, Edaily Reporter] Single, low-dose subretinal administration of NG101 led to an 89% reduction in annualized anti-VEGF injections over 52 weeks. 83% of patients in Cohort 1 required one or fewer supplemental injections, with 50% remaining completely injection-free.</p>
          <p contents-hash="be206ad9998f981b5765bdbb2fdf9035c42cf4144e7619bbda716e57809b91fe" dmcf-pid="xjv71sUZr9" dmcf-ptype="general">Favorable safety profile across all 20 enrolled subjects, with no NG101-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) reported. Stable visual acuity and anatomical outcomes maintained through 52 weeks.</p>
          <figure class="s_img figure_frm origin_fig" contents-hash="74553b41b7f7ce3ba90e47215b86ef53c8c33d58cdbbdd2788c394b5bb13561c" dmcf-pid="ypPkL9AiEK" dmcf-ptype="figure">
           <p class="link_figure"><img class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202605/07/Edaily/20260507144620716xmfy.png" data-org-width="215" dmcf-mid="63dsA6rNIf" dmcf-mtype="image" height="auto" src="https://img2.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202605/07/Edaily/20260507144620716xmfy.png" width="215"></p>
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          <p contents-hash="abff75746225b2114d627e8a430c05750b58de7d94beef0af56e9e515417bfcf" dmcf-pid="WUQEo2cnIb" dmcf-ptype="general">Elisigen Inc. (formerly Neuracle Genetics), a clinical-stage biotechnology company developing Adeno-Associated Virus (AAV) gene therapies, today announced positive 52-week safety and efficacy data from the first-in-human Phase 1/2a SENSE study of NG101 for the treatment of wet age-related macular degeneration (wAMD). Presented at the 2026 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Denver, Colorado, the findings were designated as a "Hot Topic" by the program committee.</p>
          <p contents-hash="5021ae64e0f358161143b5275bc1904397125b0685dcfa60b8c784982d500de2" dmcf-pid="YrX2uvKpwB" dmcf-ptype="general">According to the presentation, patients in the low-dose cohort experienced an 89% reduction in annualized anti-VEGF injection rates. Prior to receiving NG101, patients in this cohort required an annual average of 9.8 anti-VEGF injections. Following a single subretinal administration of NG101, the mean annualized injection rate dropped to just 1.1.</p>
          <p contents-hash="51d98133a769614d4300b148e085c848e839a3f3c7ba2285681c941b51b4df62" dmcf-pid="GmZV7T9Urq" dmcf-ptype="general">Furthermore, 83% of patients (five out of six) required one or fewer supplemental injections, and 50% (three out of six) were completely injection-free during the 52-week post-treatment period. Key functional and anatomical measures, including Best Corrected Visual Acuity (BCVA) and Central Subfield Thickness (CST), remained stable throughout the 52-week period.</p>
          <p contents-hash="c387c89138e121047a3e7207798f78b0910a8e2f07b8dc1565f01cc1a1e1ad65" dmcf-pid="Hs5fzy2uIz" dmcf-ptype="general">The data address a significant unmet need in the wAMD treatment landscape. The current standard of care requires patients to undergo frequent, often lifelong, intraocular injections to preserve their vision. This heavy treatment burden frequently leads to undertreatment and subsequent vision loss in real-world settings. By providing sustained disease control from a single subretinal injection, NG101 aims to address this treatment burden.</p>
          <p contents-hash="0f2219aeea6421fb2ca2e0bf728ac2683d03b040001588fa07881e28eb02e6e2" dmcf-pid="XO14qWV7E7" dmcf-ptype="general">“Presenting NG101’s clinical data at ARVO, the world's premier ophthalmology conference, is a significant milestone for our program," said Jongmook Kim, CEO of Elisigen. "This was a tremendous opportunity to introduce the global ophthalmology community to the clinical potential of NG101, which can dramatically reduce the treatment burden for patients with just a single, low-dose administration.”</p>
          <p contents-hash="68d0e3ef3a6db0c87fae8c46307f673dfb47ba4fd1a0cf7882738a1ee72be298" dmcf-pid="ZIt8BYfzOu" dmcf-ptype="general">The poster also presented a favorable safety profile. NG101 continues to be generally well-tolerated across all 20 subjects enrolled in the dose-escalation study. No NG101-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) have been reported as of the data cutoff. Investigators reported no drug-related adverse events associated with retinal pigment epithelium (RPE) changes, and no cases of hypotony, vascular occlusion, endophthalmitis, vasculitis, or retinitis.</p>
          <p contents-hash="ab934fa4bfaf0e8be48c82c95a51d99ab674e870b58a1e1b4e7ff3d036e9fea6" dmcf-pid="5CF6bG4qwU" dmcf-ptype="general">The ongoing, multicenter, open-label SENSE study is currently evaluating escalating doses of the gene therapy. Elisigen expanded its highest-dose cohort from six to eight patients and completed enrollment in December 2025.</p>
          <p contents-hash="95a17e3fb6665fb9a3b4f2e0d29b47d33c5e54c61163be1ebf42bfd6935b80ec" dmcf-pid="1h3PKH8BEp" dmcf-ptype="general">Overall, the presentation concluded that achieving a favorable 52-week safety profile alongside a significantly reduced treatment burden at such a low dose strongly validates the company's biofactory gene therapy approach.</p>
          <div contents-hash="15b8331e24ccda6933b0dd68a06a05cf91a15363c43c89bf40613e00e8613e60" dmcf-pid="tl0Q9X6br0" dmcf-ptype="general">
           Research and development of NG101 is supported by the Korea Drug Development Fund, funded by the Ministry of Science and ICT, Ministry of Trade, Industry and Energy, and Ministry of Health and Welfare (Republic of Korea).
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          <p contents-hash="83988a908d2afdd07b0a22f0ca22d047206cb9ac77d86238e24d04f14e25b421" dmcf-pid="FSpx2ZPKO3" dmcf-ptype="general">김승권 (peace@edaily.co.kr) </p>
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