NEWTON, Mass.– Inflammasome Therapeutics announced Thursday that its investigational intraocular implant K8 reduced lesion growth in Geographic Atrophy (GA) by more than 50% after three months of treatment in an initial patient cohort. The therapy, based on the company’s proprietary class of inflammasome inhibitors called Kamuvudines, is being evaluated in a multicenter 30-patient, six-month safety and dose-escalation trial.
In the first cohort of 10 treated eyes, patients receiving a low-dose implant showed an average 53% reduction in lesion growth compared to untreated eyes. Best corrected visual acuity also remained stable in treated eyes, improving by an average of 1.4 ETDRS letters, while untreated eyes continued to decline, losing 1.9 ETDRS letters.
“The trial is relatively small and was not designed to show statistical significance, so achieving such a large effect with a p value of 0.03 is extremely encouraging,” said Paul Ashton, Ph.D., CEO and co-founder of Inflammasome Therapeutics. “Vision trends were also positive, as eyes receiving the K8 implant had essentially stable vision.”
The mid-dose cohort has completed enrollment, with a high-dose cohort currently underway. GA, a leading cause of blindness, affects about one million people in the United States and more than eight million worldwide. Current FDA-approved treatments — Apellis Pharmaceuticals’ SYFOVRE® and Iveric Bio’s IZERVAY™ — reduce lesion growth by roughly 20% with monthly injections but have not demonstrated a reduction in vision loss over 12 months in Phase III trials.
“We are encouraged by both the increased magnitude and duration of the effect seen so far with the K8 implant,” said Jayakrishna Ambati, M.D., co-founder of Inflammasome Therapeutics. He explained that K8’s unique mechanism targets multiple inflammasomes, blocking inflammatory toxins such as complement, amyloid beta, oxidative stress factors, and retrotransposons, which drive disease progression.
Beyond GA, inflammasome activation is implicated in neuroinflammatory and ocular conditions including Alzheimer’s disease, ALS, Parkinson’s disease, multiple sclerosis, and diabetic macular edema. K8 belongs to a novel class of drugs derived from nucleoside reverse transcriptase inhibitors (NRTIs), historically used to treat HIV. While NRTIs themselves show potential for repurposing, systemic toxicity limits their use, making Kamuvudines a promising alternative.
Inflammasome’s progress highlights growing momentum in the GA treatment market, where demand remains high for therapies that not only slow lesion growth but also preserve vision.
