Inflammasome Therapeutics has initiated a Phase I clinical trial with the first patient dosed with dual inflammasome inhibitor, K8, to potentially treat diabetic macular oedema (DME).
The study is designed to evaluate the safety and preliminary efficacy of K8 when administered as an intravitreal injection over a 24-week period.
This non-randomised, open-label study will explore the effects of a single dose of K8 in previously untreated patients with DME.
Led by Dr Michelle Abou-Jaoude from the University of Kentucky in the US, the trial is anticipated to conclude this year and will have five subjects.
Primary outcome measures for the study include the mean variation in central subfield thickness from baseline, mean change in best-corrected visual acuity (BCVA) and adverse effects reported during the trial.
This trial is claimed to be the first study to investigate the treatment of DME with a dual inflammasome inhibitor that acts on the inflammasome activation in the eye.
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The drug will be delivered through a new implant system, which allows for the sustained release of the compound at fixed rates and duration.
Inflammasome Therapeutics focuses on progressing the development of treatments for common degenerative ailments and enhancing new delivery technologies for the sustained release of such therapeutic agents.
The company has detected and licensed a series of molecules, known as Kamuvudines, which have demonstrated success in hindering inflammasome activation in cell cultures and animal models.
It is now progressing its drugs into the clinic to treat various eye ailments and neurodegenerative conditions, including Alzheimer’s disease.
Inflammasome Therapeutics CEO Dr Paul Ashton said: “This marks the second clinical study for our Kamuvudines, and both are utilising 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 three months.
“Kamuvudines are unique in that they inhibit both NLRP3 and NLRC4, two inflammasomes thought to underlie the inflammatory processes responsible for disease progression in DME.”