Krystal生物技术公司在KB803的III期IOLITE试验中为首位患者给药Krystal Biotech Doses First Patient in Phase III IOLITE Trial for KB803

动脉网2025-06-30

Krystal Biotech Doses First Patient in Phase III IOLITE Trial for KB803Krystal生物技术公司在KB803的III期IOLITE试验中为首位患者给药June 30, 20252025年6月30日Krystal Biotech has announced that the first patient has been ...

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This therapeutic strategy targets the fundamental molecular mechanism driving disease in DEB patients, aiming to prevent and treat recurrent corneal abrasions—a common and painful complication of DEB..KB803是一种创新的、可重复使用的眼部滴注基因疗法，旨在将两份COL7A1转基因直接递送到眼部的上皮细胞。该治疗策略针对导致DEB患者疾病的根本分子机制，旨在预防和治疗复发性角膜擦伤——这是DEB的一种常见且痛苦的并发症。Details of the IOLITE TrialIOLITE试验的详细信息IOLITE (NCT07016750) is a double-blind, placebo-controlled, multicenter Phase III trial utilizing a crossover design. The study enrolls patients 6 months of age and older with DEB. Approximately 16 patients are expected to participate.IOLITE（NCT07016750）是一项双盲、安慰剂对照、多中心的III期临床试验，采用交叉设计。研究招募了6个月及以上患有DEB的患者，预计约有16名患者参与。Each patient will initially receive a single eye drop of either KB803 (at a concentration of 10⁹ PFU/mL) or placebo to each eye once weekly for 12 weeks. Following this first period, patients will switch to the alternate treatment arm—placebo to KB803 or vice versa—for an additional 12 weeks of once-weekly administration.每位患者最初将每周一次，每次向每只眼睛滴一滴KB803（浓度为10⁹ PFU/mL）或安慰剂，持续12周。在此第一阶段之后，患者将转换到另一种治疗组——从安慰剂转为KB803，或反之亦然——再进行额外12周的每周一次给药。Notably, all drug administration will be performed in the patient’s home by a healthcare provider, reducing the need for frequent clinic visits..特别是，所有药物管理都将在患者家中由医疗保健人员进行，减少了频繁去医院的需要。Primary Endpoint and Study Assessments主要终点和研究评估The primary endpoint of IOLITE is the change in the average number of days per month with corneal abrasion symptoms while receiving KB803 compared to placebo. To account for expected high inter-patient variability, statistical analysis will focus on intra-patient paired measurements. 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