Products and Pipeline:
GA K8 Implant Phase I/II
DME Oral K9 Phase I
TED Oral K9 Phase I
Products:
Our two lead compounds K8 and K9 both inhibit inflammasome activation and the associated inflammatory cascade, specifically IL-1β, IL-18 and downstream cytokines such as IL-6, TNF- and interferon-γ. These cytokines are critical to the development multiple neuro-inflammatory and ocular disease such as geographic atrophy, thyroid eye disease and diabetic macular edema.
K8 and K9 are small molecules with excellent stability profiles.
K8 Ocular Implant:
K8 is a powerful inflammasome inhibitor and has been found to be highly effective in pre-clinical models of GA. We have developed tiny, bioerodible, injectable implants that are injected into the vitreous where they provide sustained release of our drug K8 directly to the back of the eye while avoiding systemic exposure.
Preliminary data from our ongoing clinical trials indicate the injection procedure is well tolerated and suggests powerful efficacy.
A 30 patient Phase I/II dose ranging clinical trial (IND# 162078) is currently underway in the US with pivotal trials anticipated in 2026.
K9 Oral:
K9 is a stable, water-soluble drug that has good oral bioavailability, a 2-hour half-life in the blood and readily penetrates the blood/brain and blood/eye barriers.
K9 is currently in Phase I clinical trials in thyroid eye disease and diabetic macular edema (IND# 170554). While these trials are ongoing, preliminary data confirmed target engagement with dramatic reductions in production of IL-1β, IL-18, IL-6, TNF- and interferon-γ.
The same drug has application in neurological diseases, such as Alzheimer's and Parkinson’s Diseases, ALS and Multiple Sclerosis.
