Inflammasome sets sights on Phase III amid eye disease drug's mid-stage score

Inflammasome Therapeutics is targeting a Phase III study for its geographic atrophy (GA) therapy kamuvudine-8 (K8) after mid-stage results showed it significantly slowed disease progression. In the Phase II trial (NCT06164587), 30 patients with GA in both eyes received K8 via a bioerodible intravitreal implant at 0.3 mg, 0.7 mg, or 1.05 mg at baseline and three months. The primary endpoint compared the average rate of GA growth in treated eyes versus a pooled control group, and the 0.7 mg cohort produced a statistically significant 54% reduction in GA growth over six months. Treated patients also showed a 4.0-point improvement in a visual acuity measure at six months for lesions outside the fovea. No treatment-linked serious adverse events or dose-limiting toxicities were reported in the study. Inflammasome, a Massachusetts biotech, plans Phase III next and cites that it is designed as a dual inflammasome inhibitor. In the U.S., GA is approved only with Apellis’ Syfovre and Astellas’ Izervay.