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).
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.
“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.”
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.
Preliminary data from the low-dose cohort (1x109 vg/eye; n=6), 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.
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