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), the company said in a press release. 

In the five patients with bilateral GA who received a K8 implant in one 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. The company also noted that in all five patients, the GA lesions progressed at a much slower rate in the K8-treated eyes compared to the contralateral eyes.

Additionally, there were no drug-related intraocular or systemic safety issues identified, and patients will receive a second K8 injection at month 3 of this 6-month trial. Given the positive efficacy and safety data, the company said the trial has now been expanded to 30 patients (60 eyes). 

The next phase of this 6-month trial will 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 vs contralateral untreated eyes, the company stated in the press release.