Inflammasome Therapeutics Reports Positive Six-Month Phase 2 Results for K8 in Geographic Atrophy
0.7 mg cohort showed a 54% lower mean rate of geographic atrophy (GA) growth (slope) than control eyes; a prespecified extrafoveal analysis showed an adjusted 4.0-letter mean BCVA advantage for K8 versus control – both statistically significant.
Inflammasome Therapeutics today announced positive Phase 2 results for its investigational drug K8 in GA. Over six months, K8 was associated with significantly slower disease progression and a visual-acuity advantage, with no safety signals of concern. GA affects an estimated eight million people worldwide, including around 1.5 million in the US and 2.5 million in Europe.
In the 0.7 mg cohort, the mean rate of GA growth was 54% lower than in the pooled control group over six months (two-sided p=0.016, FDA-preferred slope analysis). A prespecified analysis of eyes with extrafoveal lesions showed a covariate-adjusted 4.0-ETDRS-letter mean advantage in best-corrected visual acuity (BCVA) for the K8-treated group versus all control eyes over six months (two-sided p=0.004).
For context, over the first six months the two FDA-approved GA treatments reduced the mean rate of growth by approximately 13–14% versus controls, and neither reported a visual-acuity benefit in its Phase 3 trials.1 All three K8 dose cohorts slowed mean GA growth against the pooled control group substantially more than those benchmarks. Cross-trial comparisons are not based on head-to-head studies.
