The following transcript has been edited for clarity.
Hello, I'm Jay Ambati, MD, from Inflammasome Therapeutics. Today at the American Society of Retina Specialists annual meeting, I presented the phase 2 clinical trial results of our multicenter 6-month trial of kamuvudine-8 (K8) in bilateral geographic atrophy (GA).
We found a spectacular reduction of GA lesion growth rate of 54% over 6 months [in the 0.7-mg cohort], which is substantially greater than the 2 approved products today. We also found the efficacy was matched not only in structure, but in function, with a 4-letter best-corrected visual acuity difference that was also statistically significant.
There were no safety signals, no choroidal neovascularization (CNV), no intraocular inflammation, no vasculitis, no endophthalmitis. And this was achieved with an every-3-month injection of a bioerodible sustained-release implant, which is substantially more durable than the current monthly regimens that we have with the approved drugs. The drug is also a nonrefrigerated product that’s preloaded, so it makes it much more convenient and safer.
We’re looking forward to starting phase 3 trials in our global pivotal program toward the end of this year or the beginning of next year. RP







