Inflammasome Therapeutics Announces First Patient Dosed in Phase 1 DME Study of the Dual Inflammasome Inhibitor K8

Inflammasome Therapeutics announced the first patient has been dosed in a phase 1 study of a novel compound in the treatment of diabetic macular edema (DME).

The 24-week study (ClinicalTrials.gov ID NCT05699759) is designed to assess safety and initial evidence of efficacy. This investigator-sponsored study, led by Dr. Michelle Abou-Jaoude of the University of Kentucky, is expected to be completed this year and will enroll five patients. Primary outcome measurements include:

• Mean change in central subfield thickness from baseline
• Mean change in BCVA (best-corrected visual acuity) as defined by the ETDRS scale
• Any adverse effects within the study period

“This marks the second clinical study for our Kamuvudines, and both are utilizing our newly designed sustained release implant system that will allow the drug to be released directly at the retina at a predetermined release rate. We initially are targeting a time period of 3 months,” said Dr. Paul Ashton, CEO of Inflammasome Therapeutics, said in a company news release. Late in 2023, the company announced it would be entering the clinic with a similar implant for treatment of geographic atrophy (GA).

Recent scientific research indicates that inflammasome activation may be the cause of neuroinflammatory diseases such as Alzheimer’s disease, Parkinson’s disease, ALS, and multiple sclerosis, among many others. These diseases continue to be challenging for the development of effective treatments. “Because of the abundant scientific evidence pointing to inflammasome activation as the cause of the processes that give rise to these diseases, we have been developing Kamuvudines that are specifically designed for these neurological diseases and can penetrate into the brain and CNS from a simple oral tablet,” said Dr. Ashton. “We look forward to entering the clinic with these for one or more of these indications this year.”