Inflammasome Therapeutics Announces Positive Topline Data from K8 Implant Trial for GA
Inflammasome Therapeutics reported 3-month results from a clinical trial of its K8 implant in patients with geographic atrophy (GA). The study, conducted at the University of Kentucky (NCT06164587), demonstrated significant efficacy and safety following a single injection of K8.
In the initial cohort of five patients with bilateral GA, the K8 implant, administered to one eye, reduced the mean growth of GA lesions by 66% compared to the untreated contralateral eyes (P=0.029, mixed effects model). The trial used fundus autofluorescence (FAF) imaging analyzed by an independent masked reading center. Across all patients, lesion growth in K8-treated eyes was substantially slower than in untreated eyes. No drug-related intraocular or systemic safety concerns were identified.
Given these results, the trial has been expanded to include 30 patients (60 eyes), with participants receiving a second K8 injection at the 3-month mark during this 6-month study, according to Inflammasome.
“We are excited to see such rapid and dramatic reduction in GA lesion growth within just 3 months of a single injection,” Jayakrishna Ambati, MD, co-founder of Inflammasome Therapeutics, said in a company news release. “Natural history studies reveal that lesion growth rates in both eyes of bilateral GA patients differ by less than 5%. Therefore, achieving a 66% reduction in treated eyes is strong evidence of efficacy. K8’s unique mechanism of action, which targets complement activation and other inflammatory pathways, underscores its potential as a transformative therapy for GA.”
Dr. Ambati highlighted the broad efficacy of K8, noting that lesion growth reduction was observed irrespective of disease patterns, lesion location, or other AMD characteristics.
“These results demonstrate the potential for K8 to break through the efficacy ceiling observed with existing FDA-approved anti-complement therapies, which achieve only modest reductions in lesion growth after a year of monthly injections," said Paul Ashton, PhD, CEO and co-founder of Inflammasome Therapeutics. "The significant 66% reduction observed with just five patients is indicative of K8’s robust effect and supports our belief in its superior therapeutic profile.”
The next phase of the trial will evaluate safety and efficacy in up to 30 patients, focusing on GA lesion growth reduction and safety outcomes over 6 months with injections administered every 3 months.