Inflammasome Therapeutics, a private, clinical-stage biotech company developing dual inflammasome inhibitors for prevalent ophthalmic and neurodegenerative diseases, announced completion of enrollment of a multicenter phase 2 dose-ranging trial (NCT06164587) for its dual inflammasome inhibitor, K8, for geographic atrophy (GA).

Thirty patients with bilateral GA were recruited at nine centers throughout the Unites States. In this 6-month trial, patients received 3-month biodegradable, intraocular implants containing 0.3, 0.7, or 1.05 mg of K8 in one eye, with the untreated, contralateral eyes serving as controls. After 3 months, patients received a second injection and were followed for another 3 months. The primary endpoints of the trial were safety and efficacy assessed by changes in GA lesion size growth, which is graded by an independent, masked reading center.

In September, the company reported that in the 0.3-mg cohort (n = 10), treated eyes showed a greater than 50% reduction in lesion growth compared with untreated control eyes after 3 months.

“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 continued.