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

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).

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

Study Design and Patient Population

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.

Key Trial Parameters:

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

       • Treatment was administered at baseline and again at three months

       • The untreated contralateral eye served as a control

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

Interim Results and Mechanism of Action

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.

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.

“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.

“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.