K8 inhibitor yields positive efficacy, safety in GA at 3 months in small trial

Key takeaways:

• A single injection of the implant demonstrated reduced geographic atrophy lesion growth.
• No serious drug-related ocular or systemic adverse events were reported.

The K8 implant, a first-in-class dual inflammasome inhibitor, demonstrated positive efficacy and safety at 3 months in five patients with bilateral geographic atrophy, according to a press release from Inflammasome Therapeutics.

In the clinical trial, each patient received a single injection of the K8 implant in one eye. As measured by fundus autofluorescence imaging, treated eyes demonstrated a “rapid and substantial reduction of GA lesion growth,” with a mean reduction of 66% at 3 months compared with untreated eyes (P = .029), according to the release. Lesions also progressed at a slower rate in K8-treated eyes compared with contralateral eyes.

Safety outcomes were positive, with no drug-related ocular or systemic serious adverse events reported.

In light of these outcomes, patients will now receive a second K8 injection at month 3 of the 6-month trial, which will expand to include 60 eyes of 30 patients, with primary endpoints of safety and the difference in GA lesion growth in treated eyes compared with contralateral untreated eyes.

“We are excited to see such rapid and dramatic reduction of GA lesion growth within only 3 months following a single injection,” Jayakrishna Ambati, MD, co-founder of Inflammasome Therapeutics, said in the release. “Natural history studies have shown that in bilateral GA patients, the lesion growth rates in the two 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.”

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