Inflammasome Therapeutics expands K8 trial following positive 3-month results

Inflammasome Therapeutics announced positive topline 3-month data from a clinical trial of its K8 implant in patients with geographic atrophy (GA). Positive efficacy and safety data were observed at 3 months after a single injection of K8 in this study conducted at the University of Kentucky (NCT06164587).

According to the company’s press release¹, in the 5 patients with bilateral GA who received a K8 implant in 1 eye, there was a mean reduction in GA lesion growth of 66% at 3 months compared to the untreated contralateral eyes with GA (p = 0.029, mixed effects model), as measured by fundus autofluorescence (FAF) imaging by an independent masked reading center. In all 5 patients, the GA lesions progressed at a much slower rate in the K8-treated eyes compared to the contralateral eyes. No drug-related intraocular or systemic safety issues were identified, and patients will receive a second K8 injection at month 3 of this 6-month trial. Based on this positive efficacy and safety data, the trial has been expanded to 30 patients (60 eyes).

Jayakrishna Ambati, MD, co-founder of Inflammasome Therapeutics spoke to the value these results provide, saying, “Natural history studies have shown that in bilateral GA patients the lesion growth rates in the 2 eyes are almost identical, with less than 5% difference between eyes. Therefore, a 66% reduction in K8-treated eyes compared to contralateral eyes of the same patients provides strong evidence of efficacy. K8 has a unique mechanism of action whereby it blocks the effects of complement activation as well as numerous other inflammatory pathways in GA, a multifactorial disease. The rapid, profound, and uniform clinical efficacy seen in all 5 patients in this trial is consistent with the extensive preclinical data showing this multipronged protective action of K8. Remarkably, lesion growth was reduced irrespective of the FAF pattern, whether the lesions were fast- or slow-growing, location or duration of disease, or type of AMD drusen, demonstrating the broad-based action of K8.”¹

The company plans to continue the development of this candidate by moving to the next phase of this 6-month trial to further evaluate safety and efficacy of K8 injected every 3 months in up to 30 participants with GA. The primary endpoints are safety and the difference in GA lesion growth in treated eyes versus contralateral untreated eyes.¹

Reference:

1. Inflammasome Therapeutics Announces Topline 3-month Data from a Clinical Trial of its First-in-Class Dual Inflammasome Inhibitor, K8, in Geographic Atrophy, Demonstrating Rapid, Substantial and Significant Efficacy and Safety. January 15, 2025. Accessed January 16, 2025. https://www.businesswire.com/news/home/20250115779420/en/Inflammasome-Therapeutics-Announces-Topline-3-month-Data-from-a-Clinical-Trial-of-its-First-in-Class-Dual-Inflammasome-Inhibitor-K8-in-Geographic-Atrophy-Demonstrating-Rapid-Substantial-and-Significant-Efficacy-and-Safety

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