Inflammasome Therapeutics Reports Promising 3-Month Clinical Data for K8 in Geographic Atrophy

Inflammasome Therapeutics, a biotech company based in Newton, Massachusetts, has announced promising results from a clinical trial involving its K8 implant. This implant is designed to treat geographic atrophy (GA), a severe form of dry age-related macular degeneration, a condition that affects millions globally. The trial, conducted at the University of Kentucky, revealed encouraging data on the efficacy and safety of K8, a novel dual inflammasome inhibitor.

The trial involved five patients with bilateral GA, each receiving a K8 implant in one eye. The study showed a significant reduction in the growth of GA lesions in the treated eyes, with a 66% decrease compared to the untreated eyes. This result was statistically significant, with a p-value of 0.029, as determined by an independent reading center using fundus autofluorescence imaging. Furthermore, the progression of GA lesions was consistently slower in the eyes treated with the K8 implant. Notably, the trial reported no drug-related safety issues, either intraocular or systemic. Based on these positive outcomes, the study's scope has been expanded to include 30 patients.

Dr. Jayakrishna Ambati, co-founder of Inflammasome Therapeutics, expressed excitement over the rapid reduction in GA lesion growth following just one injection of K8. He highlighted the unique mechanism of K8, which blocks complement activation alongside various inflammatory pathways in GA, a multifactorial disease. The K8 implant, therefore, offers a broad-based therapeutic action, effectively reducing lesion growth regardless of different FAF patterns, lesion growth rates, disease duration, or type of AMD drusen.

Paul Ashton, CEO and co-founder of Inflammasome Therapeutics, shared optimism about the initial results. He noted the significant and rapid efficacy achieved with a single K8 injection, which surpasses the results of currently available FDA-approved treatments that require monthly injections. These approved treatments typically offer only about a 20% reduction in lesion growth over 12 months. Ashton pointed out that the robust 66% reduction observed in this trial, albeit with only five patients, suggests K8's potential to surpass the efficacy limitations of existing anti-complement drugs for GA.

The trial will continue to assess the safety and efficacy of the K8 implant, now administered every three months, in a larger group of 30 participants. The main objectives are to confirm safety and evaluate the difference in lesion growth between treated and untreated eyes.

Inflammasome Therapeutics, a private company, focuses on developing Kamuvudines, dual inflammasome inhibitors, for various ocular and neurological diseases. The K8 implant is their lead product for retinal conditions like GA. GA is a widespread condition affecting millions, characterized by the accumulation of multiple toxic substances in the eye, leading to gradual cell death in the macula and potential vision loss. Current FDA-approved drugs target only one aspect of this process, offering limited efficacy and some risk of developing wet AMD.

The global market for GA therapy is substantial, exceeding $30 billion annually. There is a strong interest in developing new treatments, with numerous clinical trials targeting specific toxic elements linked to GA. In contrast, K8's mechanism of action, which targets the final common pathway of inflammasome activation, could result in improved efficacy for patients.

Kamuvudines, beyond treating GA, may also be applicable to various neuro-inflammatory diseases such as ALS, Parkinson’s, Alzheimer’s, and Multiple Sclerosis. Preliminary data indicate the potential efficacy of Kamuvudines in models of neurodegeneration. Inflammasome Therapeutics is exploring oral formulations of Kamuvudines for these conditions and plans to initiate clinical trials in neurodegenerative diseases soon. Dr. Ambati has spent over a decade researching Kamuvudines, contributing significantly to understanding their role in inhibiting inflammasome activity, a key driver of many chronic diseases.