Inflammasome Therapeutics has completed enrollment in a phase 2 trial evaluating its investigational dual inflammasome inhibitor, K8, for geographic atrophy (GA). Thirty patients with bilateral GA were enrolled at 9 US centers. Each participant received a biodegradable intraocular implant containing 1 of 3 K8 doses—0.3 mg, 0.7 mg, or 1.05 mg—in 1 eye, while the fellow eye served as an untreated control. A second injection is administered at 3 months, with follow-up through month 6. The study’s primary endpoints are safety and changes in GA lesion growth, assessed by a masked reading center.

Data from the lowest-dose cohort showed more than a 50% reduction in lesion growth at 3 months compared with untreated eyes, the company reported in September.

K8 is part of a new class of inflammasome inhibitors, kamuvudines, which are derived from nucleoside reverse transcriptase inhibitors (NRTIs), a class of anti-HIV drugs. They retain the anti-inflammasome activity of NRTIs while being engineered to reduce systemic toxicity, making them candidates for treating ocular and neuroinflammatory diseases. In addition to K8, Inflammasome Therapeutics has initiated a pair of phase 1/2 trials for a second kamuvudine, K9, which is orally delivered, for diabetic macular edema and thyroid eye disease. RP