Inflammasome Therapeutics completes phase 2 trial enrollment for K8 in GA

Inflammasome Therapeutics has completed enrollment in a multicenter phase 2 dose-ranging trial (NCT06164587) for its dual inflammasome inhibitor, K8, for geographic atrophy (GA).

K8 is a member of a new class of inflammasome-inhibiting drugs called Kamuvudines. They are derivatives of a class of anti-HIV drugs, NRTIs, which have potential for repurposing as treatments but have significant systemic toxicity impeding their use. Kamuvudines retain the anti-inflammasome activity of NRTIs but are designed to be safer.¹ The K8 implant is designed to block multiple disease pathways with intraocular injections every 3 months.

K8 is one of many Kamuvudines that the company is developing for ophthalmic and neurological conditions, according to the company.

For the trial, 30 patients with bilateral GA are enrolled across 9 centers in the US. In this 6-month trial, patients will receive 3-month biodegradable intraocular implants containing 0.3, 0.7, or 1.05 mg K8 in 1 eye, with the contralateral untreated eyes serving as controls. After 3 months, patients will receive a second injection and will be followed for another 3 months. The primary endpoints for the trial are safety and efficacy assessed by changes in GA lesion size growth, which is graded by an independent, masked reading center.

Paul Ashton, PhD, co-founder and chairman/CEO of Inflammasome Therapeutics, commented on the trial enrollment, saying, “GA is the most serious form of dry macular degeneration, affecting over one million people in the US. It is a multifactorial disease, and K8 targets multiple GA disease pathways via a novel mechanism of action. 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.”

Jayakrishna Ambati, MD, co-founder of Inflammasome Therapeutics, discovered Kamuvudines, according to the company. “Based on the preliminary data from this trial, we are very encouraged by the magnitude of the effects seen so far with the K8 implant,” Ambati said.

Earlier in 2025, Inflammasome released early positive data from the first cohort (0.3 mg K8) showing that K8 was found to have reduced GA lesion area growth by more than 50% in its first human clinical trial of the drug. The reduced GA lesion area growth findings were taken from the initial cohort of patients, which was a single-center, open-label, 26-week study that worked to evaluate the safety and treatment efficacy of K8 in patients with GA due to age-related macular degeneration (AMD). Up to 5 participants were slated to receive study medication via intravitreal injections, with 7 scheduled visits. Those visits occurred at screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, and week 26.²

References:

1. Inflammasome Therapeutics Completes Enrollment of Multicenter Phase II Dose- Ranging Study for First-in-Class Dual Inflammasome Inhibitor, K8, to Treat Geographic Atrophy. Published November 25, 2025. Accessed December 1, 2025. https://www.businesswire.com/news/home/20251125986655/en/Inflammasome-Therapeutics-Completes-Enrollment-of-Multicenter-Phase-II-Dose--Ranging-Study-for-First-in-Class-Dual-Inflammasome-Inhibitor-K8-to-Treat-Geographic-Atrophy

2. Joy J. Inflammasome Therapeutics reports positive results from early K8 GA trial. Published September 17, 2025. Accessed December 1, 2025. https://www.ophthalmologytimes.com/view/inflammasome-therapeutics-reports-positive-results-from-early-k8-ga-trial