Inflammasome Therapeutics has completed patient enrolment for its multicentre Phase II trial of K8, a dual inflammasome inhibitor, aimed at treating geographic atrophy (GA).
K8 is part of Kamuvudines, a new class of inflammasome-inhibiting drugs, derived from anti-human immunodeficiency virus nucleoside reverse transcriptase inhibitors but developed to avoid the systemic toxicity of the original drugs.
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Primary endpoints of the dose-ranging trial include efficacy and safety, evaluated by changes in GA lesion size, assessed by a masked independent reading centre.
The trial involved 30 patients with bilateral GA across nine US centres. Patients received a biodegradable intraocular implant releasing 0.3mg, 0.7mg, or 1.05mg of K8 in one eye while the other eye served as the untreated control.
Patients will be given a second injection after three months and followed for another three months.
Initial results from the 0.3mg cohort, in September 2025, showed that treated eyes had an over 50% reduction in growth of lesions compared to untreated eyes after three months.
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By GlobalDataInflammasome Therapeutics co-founder, chair, and CEO Paul Ashton said: “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 enrolment and are optimistic that the six-month data will continue to show a strong reduction in lesion growth with few side effects.”
Inflammasome Therapeutics co-founder Jayakrishna Ambati said: “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.”
Recently, Inflammasome and The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, US, signed a contract for the design of a new Healey ALS MyMatch trial of oral Kamuvudine-9 to treat amyotrophic lateral sclerosis (ALS).
