Inflammasome Therapeutics Reports 3-Month Trial Data for Inflammasome Inhibitor in Geographic Atrophy

Inflammasome Therapeutics Reports Topline 3-Month Trial Data for Novel Geographic Atrophy Treatment

The findings revealed a significant reduction in lesion growth and a strong safety profile following a single injection of a first-in-class dual inflammasome inhibitor implant.

Inflammasome Therapeutics (Massachusetts, USA) has announced encouraging three-month results from a U.S. clinical trial evaluating the sustained-release intravitreous implants of its dual inflammasome inhibitor—K8—for geographic atrophy (GA).

K8 utilizes a novel mechanism of action targeting multiple pathways involved in GA progression— including complement activation and various inflammatory pathways. This approach contrasts with currently approved GA treatments Syfovre^® (pegcetacoplan; Apellis Pharmaceuticals; Massachusetts, USA) and Izervay™ (avancincaptad pegol; Astellas Pharma; Tokyo, Japan), which focus on a single pathway.

*[Schematic detailing key effectors of the complement pathway, courtesy of the Journal of Clinical Medicine.]*

Conducted at the University of Kentucky with imaging reviewed by an independent masked reading center, the study involved five patients with bilateral GA. The data showed a 66% reduction in GA lesion growth in treated eyes compared to untreated contralateral eyes (p=0.029) at three months after a single implant injection.

“Natural history studies have shown that in bilateral GA patients, lesion growth rates in two eyes are almost identical, with less than 5% difference between eyes,” said Inflammasome Therapeutics Co-Founder Dr. Jayakrishna Ambati. “Therefore, a 66% reduction in K8-treated eyes provides strong evidence of efficacy.”

CEO Paul Ashton underscored the potential of K8, stating, “We are delighted that a single injection of K8 delivered via our unique drug-delivery technology achieved substantial and rapid efficacy that is much greater and faster than the approximate 20% reduction reported for the two FDA-approved drugs with monthly injections after 12 months.”

Furthermore, no drug-related ocular or systemic adverse events were observed in the trial, indicating a strong safety profile. Following the positive results, the trial has been expanded to include 30 patients, with participants receiving a second injection at the three-month mark of the six-month study.

The ongoing trial will further evaluate the safety and efficacy of K8 administered every three months. The company believes K8 could address the unmet needs of GA treatment by targeting the final common pathway of multiple toxic substances that contribute to the disease.