Best-performing dose of kamuvudine K8 lesion cut growth rate by 43% at 3 months, 70% at 6 months
NEW ORLEANS — A new therapeutic approach to geographic atrophy (GA) showed promise for slowing disease progression, according to a preliminary clinical trial.
The rate of GA lesion growth decreased by 54% after 6 months with a bioerodible implant that continually releases the dual inflammasome inhibitor kamuvudine K8 (K8). The effect on GA growth rate increased over time, from 43% during the first 3 months to 70% during months 3-6. The GA growth rate was slower in the treated versus untreated eye in 25 of 30 patients.
Of the three dose levels evaluated, the mid-level dose proved most effective. No drug-related adverse events (AEs) occurred at any dose, reported Liangbo Shen, MD, of Duke University Medical Center in Durham, North Carolina, at the American Academy of Ophthalmology meeting.
Enumerating convenience advantages K8 offers over existing GA treatment options, Shen said, “K8 is a quarterly injection, requires no refrigeration, and comes in a preloaded injector.”
On the basis of the results, a phase III pivotal clinical program has been planned, he added.
During a discussion, Jay M. Stewart, MD, of the University of California San Francisco, noted that investigators pooled results from the untreated eyes, resulting in “a lot of complexity that we’re not used to seeing. To what extent do you think an outlier or two in one of those groups could sway the results and make us think that one of the groups is having better efficacy than the other?”
Shen agreed and said investigators also performed an analysis comparing treated and untreated eyes in the same patients, and the results were similar after adjustment for sample size and other factors.
“We need a longer, larger study to investigate the treatment efficacy,” said Shen. “But it is encouraging to see a phase II trial with a significant reduction in GA growth rate.”
Although the trial was not powered for visual acuity, investigators compared best-corrected visual acuity (BCVA) at baseline and at the end of the study and found an improvement favoring the K8-treated eyes. Noting that vision was not masked in the study, Stewart asked how the results should be interpreted.
Read more: Geographic Atrophy Growth Rate Reduced by Half With Anti-Inflammasome Implant | MedPage Today
Source: MedPage Today