Inflammasome Therapeutics doses first patient in Phase 1 trial of Kamuvudine-8 for geographic atrophy

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Inflammasome Therapeutics has dosed the first patient in its Phase 1 clinical trial (NCT06164587) evaluating Kamuvudine-8 in subjects with geographic atrophy (GA).

The trial, sponsored by the University of Kentucky, is a single-center, open-label, non-randomized, 26-week study, expected to enroll up to 5 patients with with GA due to age-related macular degeneration (AMD). Over the course of the study, patients will have 7 scheduled visits: Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26.2 Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.^1,2

Primary endpoints include mean change in best-corrected visual acuity (BCVA), change in size of geographic atrophy (GA) on fundus autofluorescence (FAF) and optical coherence tomography (OCT), and more.²

Kamuvudine-8 (K8) is administered to the back of the eye via a sustained released intravitreal implant. According to the company, K8 was specifically designed for retinal delivery and the implants and injector system were crafted to deliver the drug.¹

Paul Ashton, PhD, president and CEO of Inflammasome Therapeutics stated in a press release from the company, that he thinks Inflammasome can offer a treatment for GA that competitors cannot with the targeting of inflammasome activation.

“That’s where we believe we provide a distinctive and significant difference,” said Ashton. “Our Kamuvudines have been shown in pre-clinical studies to block inflammasome activation caused by multiple toxic pathways – complement, amyloid beta, iron overload, retrotransposons, etc. If we can block inflammasome activation in the clinic, we believe we can have a profound effect on the disease by blocking multiple pathways.”

References:

1. Inflammasome Therapeutics Announces First Patient Dosed in Geographic Atrophy (GA) Clinical Trial. Press release; April 29, 2024. Accessed April 30, 2024. https://www.businesswire.com/news/home/20240429438564/en/Inflammasome-Therapeutics-Announces-First-Patient-Dosed-in-Geographic-Atrophy-GA-Clinical-Trial?utm_campaign=shareaholic&utm_medium=email_this&utm_source=email

2. Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy (K8 for GA). NCT06164587. https://clinicaltrials.gov/study/NCT06164587?tab=table