Inflammasome Therapeutics Completes Enrollment for Phase 2 Study of K8 in Geographic Atrophy

炎性小体治疗公司完成K8在地理萎缩二期研究的入组工作

November 26, 2025

2025年11月26日

Inflammasome Therapeutics has announced the completion of patient enrollment in its multicenter Phase 2 dose-ranging trial (NCT06164587) evaluating K8, a first-in-class dual inflammasome inhibitor, for the treatment of geographic atrophy (GA) associated with dry age-related macular degeneration (AMD)..

炎性小体治疗公司宣布，其多中心二期剂量探索试验（NCT06164587）已完成患者入组，该试验评估了K8（一种首创的双重炎性小体抑制剂）用于治疗与干性年龄相关性黄斑变性（AMD）相关的地图样萎缩（GA）。

The company is developing K8 as part of its broader pipeline targeting prevalent ophthalmic and neurodegenerative diseases using dual inflammasome inhibition strategies.

该公司正在开发K8，作为其使用双重炎症小体抑制策略、针对常见眼科和神经退行性疾病的更广泛研发管线的一部分。

Study Design and Patient Population

研究设计与患者人群

The Phase 2 clinical trial enrolled 30 patients with bilateral geographic atrophy across nine clinical centers in the United States. The study is designed to evaluate the safety and efficacy of K8 over a six-month period.

第二阶段临床试验在美国九个临床中心招募了30名双眼地理性萎缩患者。该研究旨在评估K8在六个月内的安全性和有效性。

Key Trial Parameters:

关键试验参数：

• Patients received biodegradable intraocular implants of K8 in one eye at dose levels of 0.3 mg, 0.7 mg, or 1.05 mg

• 患者单眼接受了剂量为 0.3 毫克、0.7 毫克或 1.05 毫克的 K8 生物可降解眼内植入物

• Treatment was administered at baseline and again at three months

• 在基线时进行了治疗，并在三个月后再次进行

• The untreated contralateral eye served as a control

• 未处理的对侧眼作为对照

• The primary endpoints include safety and changes in GA lesion size, as assessed by an independent, masked reading center.

• 主要终点包括由独立的、盲法评估中心评估的安全性和GA病灶大小的变化。

Interim Results and Mechanism of Action

中期结果与作用机制

In an interim update released in September, the 0.3 mg dose group (n = 10) demonstrated a greater than 50% reduction in GA lesion growth in treated eyes compared to untreated control eyes at the three-month mark.

在九月份发布的中期更新中，0.3毫克剂量组（n = 10）在三个月时，治疗眼相对于未治疗的对照眼，GA病灶生长减少了超过50%。

K8 is designed to act on multiple pathogenic pathways involved in GA progression, utilizing a dual inflammasome inhibition mechanism that distinguishes it from current therapeutic approaches.

K8旨在作用于与GA进展相关的多条致病途径，利用一种区别于当前治疗方法的双重炎性体抑制机制。

“GA is the most serious form of dry macular degeneration, affecting over one million people in the United States. It is a multifactorial disease, and K8 targets multiple GA disease pathways via a novel mechanism of action,” said Paul Ashton, PhD, Co-founder and Chairman/CEO of Inflammasome Therapeutics..

“GA 是干性黄斑变性中最严重的形式，影响着美国超过一百万人。它是一种多因素疾病，K8 通过一种新颖的作用机制针对多个 GA 疾病通路，”Inflammasome Therapeutics 的联合创始人兼董事长/首席执行官 Paul Ashton 博士说道。

“We are delighted that this trial has completed enrollment and are optimistic that the 6-month data will continue to show a strong reduction in lesion growth with few side effects,” he added.

“我们很高兴这项试验已经完成了入组，我们乐观地认为6个月的数据将继续显示病灶生长的大幅减少且副作用很少，”他补充道。