Phase I Study Begins: K8 for Diabetic Macular Edema

In a pioneering move, Inflammasome Therapeutics has initiated a Phase 1 clinical trial to evaluate a groundbreaking drug, K8, for treating diabetic macular edema (DME). The study, spearheaded by Dr. Michelle Abou-Jaoude from the University of Kentucky, is set to conclude this year with a focus on five participants. The trial's primary objectives are to measure the central subfield thickness and best-corrected visual acuity changes, alongside monitoring any adverse effects.

K8 is a first-of-its-kind compound, classified as a dual inflammasome inhibitor, which is believed to target the activation of inflammasomes in the eye, a process linked to DME. The innovative drug delivery system involves a newly designed implant that provides a sustained release of the medication at a controlled rate over a three-month period.

Dr. Paul Ashton, CEO of Inflammasome Therapeutics, highlighted that the K8 trial is the second clinical study for Kamuvudines, a novel class of inflammasome inhibitor drugs. The company's implant system is designed to administer the drug directly to the retina, showcasing a significant advancement in treatment methods for DME.

The United States is home to an estimated 750,000 individuals with DME, a number projected to increase with the aging population. The current DME drug market is substantial, dominated by anti-VEGF drugs and intravitreal implants containing steroids. Kamuvudines stand out by inhibiting both NLRP3 and NLRC4 inflammasomes, which are implicated in the inflammatory processes that drive DME progression.

Dr. Ashton also mentioned the significant research contributions of Dr. Jayakrishna Ambati, co-founder of Inflammasome Therapeutics. Dr. Ambati has dedicated over a decade to understanding the role of inflammasomes in various ophthalmic and neurodegenerative diseases, including ALS, Parkinson's disease, and others. By modifying the structure of nucleoside reverse transcriptase inhibitors, Dr. Ambati and his team have developed a new class of drugs that inhibit inflammasomes without the associated toxicity.

The research indicates that inflammasome activation could be a root cause of several neuroinflammatory diseases. In response, Inflammasome Therapeutics is developing Kamuvudines designed to penetrate the brain and central nervous system from an oral tablet, aiming to address these challenging conditions.

Founded by Dr. Ambati and Dr. Ashton, Inflammasome Therapeutics is dedicated to advancing therapies for prevalent degenerative diseases and novel drug delivery technologies. The company is committed to creating breakthrough products through a combination of licensing agreements and internal development, with a focus on eye diseases and neurodegenerative conditions such as Alzheimer's, ALS, and MS.