Inflammasome Therapeutics announces first patient dosed in Phase 1 study of inflammasome inhibitor drug in subjects with DME

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Inflammasome Therapeutics announced the first patient has been dosed in a Phase 1 study of 1 of the company’s novel compounds in the treatment of diabetic macular edema (DME).

The company is a clinical-stage, private company, that is developing Kamuvudines, a new class of inflammasome inhibitor drugs as therapies for prevalent, degenerative diseases.¹ The trial is evaluating SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, DME.²

This investigator-sponsored study, led by Michelle Abou-Jaoude of the University of Kentucky, is expected to be completed this year and will enroll 5 patients. Primary outcome measurements include, mean change in central subfield thickness from baseline, mean change in best-corrected visual acuity (BCVA) as defined by the ETDRS scale, and any adverse effects within the study period.¹

For the trial, 300 µg of K8 will be administered intravitreally into 1 eye only, using an injector system on a 24-gauge needle to deliver a cylindrical, 3 mm long, drug eluting pellet containing the drug. Participants will be followed for 168 days (24 weeks).²

“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 three months,” said Paul Ashton, PhD, CEO of Inflammasome Therapeutics. “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.”

Secondary outcome measures for the trial include, resolution of macular edema, change in retinal thickening, change in foveal avascular zone among others.²

References:

1. Inflammasome Therapeutics Announces First Patient Dosed in Phase I Diabetic Macular Edema Study of the Dual Inflammasome Inhibitor K8. Press release; January 18, 2024. Accessed January 18, 2024. https://www.businesswire.com/news/home/20240118557124/en/Inflammasome-Therapeutics-Announces-First-Patient-Dosed-in-Phase-I-Diabetic-Macular-Edema-Study-of-the-Dual-Inflammasome-Inhibitor-K8

2. Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects With Diabetic Macular Edema. NCT05699759. https://clinicaltrials.gov/study/NCT05699759?term=NCT05699759&rank=1