NEWTON, Mass. — Inflammasome Therapeutics, a private, clinical-stage biotechnology company developing first-in-class dual inflammasome inhibitors for ophthalmic and neurodegenerative diseases, announced that it has completed enrollment in a multicenter Phase II dose-ranging clinical trial (NCT06164587) evaluating its lead candidate, K8, for geographic atrophy (GA).
The study enrolled 30 patients with bilateral GA across nine U.S. sites. Over the six-month trial period, participating patients receive a three-month biodegradable intraocular implant containing 0.3 mg, 0.7 mg or 1.05 mg of K8 in one eye, while the untreated eye serves as a control. A second injection is administered at three months, followed by an additional three-month observation period.
The trial’s primary endpoints are safety and efficacy, measured by changes in GA lesion growth as assessed by an independent, masked reading center.
In September, the company reported that in the first cohort of patients treated with 0.3 mg of K8, the 10 treated eyes showed more than a 50 percent reduction in lesion growth after three months when compared with the 10 untreated control eyes.
“GA is the most serious form of dry macular degeneration, affecting over one million people in the U.S. It is a multifactorial disease, and K8 targets multiple GA disease pathways via a novel mechanism of action,” said Paul Ashton, Ph.D., 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 continued.
Jayakrishna Ambati, M.D., co-founder of Inflammasome Therapeutics, noted that multiple toxic substances in GA—including various forms of complement, amyloid beta, retrotransposons and oxidative stressors—activate inflammasomes, leading to progressive cell death in the macula. Over time, the area of atrophy expands and may result in vision loss. He explained that the two FDA-approved GA treatments, SYFOVRE and IZERVAY, each target a single form of complement and have demonstrated approximately a 20 percent reduction in lesion growth with monthly injections, but did not show reduced vision loss over 12 months in Phase III studies.
The K8 implant is designed to block multiple disease pathways and requires intraocular dosing every three months.
“Based on the preliminary data from this trial, we are very encouraged by the magnitude of the effects seen so far with the K8 implant,” Dr. Ambati said.
