Neuracle Genetics Announces Completion of Dosing for Phase 1/2a SENSE Study of NG101 작성일 12-18 30 목록 <div class="article_view" data-translation-body="true" data-tiara-layer="article_body" data-tiara-action-name="본문이미지확대_클릭"> <section dmcf-sid="ygJ1dou5IB"> <p contents-hash="1756a431bc999aa6e4db356a9f264d31ec3e06df860aa22de9050c3033a7dcd3" dmcf-pid="WaitJg71rq" dmcf-ptype="general"> [Seungkwon kim, Edaily Reporter] Neuracle Genetics Announces Completion of Dosing for Phase 1/2a SENSE Study of NG101</p> <p contents-hash="f8961ad1217cea4415b252b6b874309bdc995b6095f2b60af83e09a727890c2a" dmcf-pid="YNnFiaztIz" dmcf-ptype="general">Dosing completed for 20 subjects in three dose-escalating cohorts; Low-dose cohort previously demonstrated a 91% reduction in annualized anti-VEGF injections with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs); Interim clinical study report (CSR) expected in 3Q 2026 following six-month follow-up of the high-dose cohort</p> <p contents-hash="9c19541f5893961e95259c1de6fdbdcaefeef284b096ea348597f492cbf64a29" dmcf-pid="GSO4slRfs7" dmcf-ptype="general">Seoul, South Korea December 18, 2025 Neuracle Genetics Inc., a clinical-stage biotechnology company developing adeno-associated virus (AAV) gene therapies, announced today the completion of dosing for the Phase 1/2a SENSE study (NCT05984927) of NG101 for the treatment of wet age-related macular degeneration (wet AMD).</p> <figure class="figure_frm origin_fig" contents-hash="5be3460790c6cd618c0e445128eced377310fa309fadf3ba756996b000ba6e38" dmcf-pid="HvI8OSe4Ou" dmcf-ptype="figure"> <p class="link_figure"><img class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202512/18/Edaily/20251218170104901mqsg.jpg" data-org-width="567" dmcf-mid="xzpk0zOcOb" dmcf-mtype="image" height="auto" src="https://img3.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202512/18/Edaily/20251218170104901mqsg.jpg" width="658"></p> </figure> <div contents-hash="5ac943d4d2cad8f0767179dfde3e8a51baba4c7521b70436d4edf2fe53982856" dmcf-pid="XTC6Ivd8OU" dmcf-ptype="general"> The SENSE study is a multicenter, open-label, dose-escalation trial evaluating the safety, tolerability, and preliminary efficacy of NG101. Originally designed to enroll 18 patients across three dose-escalating cohorts (n=6 each), the study was expanded to 20 patients with two additional subjects in the high-dose cohort. </div> <p contents-hash="efa22cc8119332914d7429ec841245c85e1301e93d6b71e7643429259171a15f" dmcf-pid="ZyhPCTJ6sp" dmcf-ptype="general">“Completion of dosing across all cohorts marks a pivotal milestone for NG101,” said Jongmook Kim, CEO of Neuracle Genetics. “The sustained efficacy and favorable safety profile demonstrated in the low-dose cohort clearly validate NG101‘s potential as a transformative treatment option for wet AMD patients. We remain focused on completing the Phase 1/2a SENSE study to support a global Phase 2b trial and strategic out-licensing discussions.”</p> <p contents-hash="3d0c044c4eefb9edcd4dc24751de72f467e57022b1e2b789ed0a5d8346503f33" dmcf-pid="5WlQhyiPO0" dmcf-ptype="general">With the completion of dosing, Neuracle Genetics expects to publish an interim report in the third quarter of 2026, following a six-month follow-up of the high-dose cohort. Long-term safety and durability will continue to be assessed for all subjects over a five-year follow-up period.</p> <p contents-hash="554c3277183f1b23e6d8b86de1dcb7fb77dd7f7a685267fd50178c14c4320a2a" dmcf-pid="1YSxlWnQm3" dmcf-ptype="general">Preliminary data from the low-dose cohort, presented at the 58th Annual Scientific Meeting of The Retina Society in September 2025, demonstrated a 91% reduction in annualized anti-VEGF injections. Best Corrected Visual Acuity (BCVA) and Central Subfield Thickness (CST) remained stable through 36 weeks, supporting the potential for durable disease control from a single administration.</p> <p contents-hash="7d2e12deecf8a16f4bbf1ca4ac319cfaf8ac7e9be3b9dcddbab13417776fa55f" dmcf-pid="tGvMSYLxrF" dmcf-ptype="general">About NG101</p> <p contents-hash="f57d9b60946abc5f8689e644322f57f3cb0c91db87d6b7fbee3745f1d9ed372b" dmcf-pid="FHTRvGoMDt" dmcf-ptype="general">NG101 is an investigational subretinal AAV gene therapy for wet AMD. It is designed to provide sustained anti-VEGF expression under Neuracle Genetics’ proprietary CAT311 promoter, with the goal of durable disease control from a single administration at a substantially lower vector dose. A Phase 1/2a open-label study is ongoing in the United States and Canada. In November 2024, the U.S. Food and Drug Administration granted Fast Track designation for NG101. In June 2025, NG101 was selected for the Clinical Support Program by the Korea Drug Development Fund (KDDF), validating the program‘s development strategy and accelerating its clinical timeline.</p> <p contents-hash="b3b5f89bf1f7a4cba0db61a18569f03f07cdcf65d9909e3efc79c2ddd62940d9" dmcf-pid="3XyeTHgRm1" dmcf-ptype="general">About Neuracle Genetics</p> <p contents-hash="63c6fe3580cce42d064babaaee7e0ccd2b8762d0ff953cf7d37894582c625ef7" dmcf-pid="0Dj7NE2us5" dmcf-ptype="general">Neuracle Genetics is a clinical-stage biotechnology company developing AAV gene therapies for ophthalmology and neurology. Proprietary platforms include the CAT311 promoter for high-efficiency transgene expression and the Helper-In-One (dual-plasmid) system for high-yield AAV vector production. The company is headquartered in Seoul, South Korea.</p> <p contents-hash="83988a908d2afdd07b0a22f0ca22d047206cb9ac77d86238e24d04f14e25b421" dmcf-pid="pwAzjDV7DZ" dmcf-ptype="general">김승권 (peace@edaily.co.kr) </p> </section> </div> <p class="" data-translation="true">Copyright © 이데일리. 무단전재 및 재배포 금지.</p> 관련자료 이전 딥시크 쇼크 1년, AI 판도 뒤흔든 '저비용 혁신' 12-18 다음 공공 DR 최대 장벽은 '예산'…하이브리드 클라우드 타진 12-18 댓글 0 등록된 댓글이 없습니다. 로그인한 회원만 댓글 등록이 가능합니다.
