kamuvudine-8 (K8) / Inflammasome Therap - LARVOL DELTA

K8 for GA: Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: University of Kentucky | Phase classification: P1 ➔ P1/2

Phase classification • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

A Prospective Phase I Clinical Trial of Intravitreal Kamuvudine 8 Implant for Geographic Atrophy (ARVO 2025) - P1 | "They have all done well with the medication injection to date without serious side effects. While it is still early, so far in the patients with follow up data, we can already start to see slowing of progression of disease in the eyes we treated as opposed to the eyes we haven't."

Clinical • P1 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Dry Eye Disease • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Kamuvudine-8 protects RPE structure and vision function in NaIO3-induced mouse Model of RPE degeneration (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • IL18 • IL1B • NLRP3 • TJP1

Protective Effects of Kamuvudine-8 in Mouse Models of Retinal Pigment Epithelial Degeneration (ARVO 2025) - "These findings suggest that K8 works by targeting and blocking inflammasome activation, a harmful process that accelerates cell damage. Currently in clinical trials, K8 holds potential as a groundbreaking treatment for preserving vision and improving quality of life for individuals with this challenging condition."

Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • TJP1

Inflammasome Therapeutics Announces Topline 3-month Data from a Clinical Trial of its First-in-Class Dual Inflammasome Inhibitor, K8, in Geographic Atrophy, Demonstrating Rapid, Substantial and Significant Efficacy and Safety (Businesswire) - P1 | N=30 | NCT06164587 | "In a U.S. clinical trial of 5 patients with bilateral GA, sustained-release intravitreous implants of K8 were well tolerated, with no drug-related ocular or systemic serious adverse events; In each of the 5 patients, eyes treated with the K8 implant displayed rapid and substantial reduction of GA lesion growth compared to their contralateral untreated eyes; The mean lesion growth in K8-treated eyes was 66% less than that of untreated contralateral eyes at 3 months after a single implant injection, (p value=0.029), as assessed by an independent masked reading center."

P1 data • Dry Age-related Macular Degeneration

K8 for GA: Evaluation of Kamuvudine-8 in Subjects with Geographic Atrophy (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: University of Kentucky | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects with Diabetic Macular Edema (clinicaltrials.gov) - P1 | N=1 | Completed | Sponsor: Michelle Abou-Jaoude | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jun 2024 | Trial primary completion date: Dec 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

K8 for GA: Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy (clinicaltrials.gov) - P1 | N=5 | Recruiting | Sponsor: University of Kentucky | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Inflammasome Therapeutics Announces First Patient Dosed in Phase I Diabetic Macular Edema Study of the Dual Inflammasome Inhibitor K8 (Businesswire) - "Inflammasome Therapeutics...announced the first patient has been dosed in a Phase 1 study of one of the company’s novel compounds in the treatment of diabetic macular edema (DME)....The 24-week study (ClinicalTrials.gov ID NCT05699759) is designed to assess safety and initial evidence of efficacy. This investigator-sponsored study, led by Dr. Michelle Abou-Jaoude of the University of Kentucky, is expected to be completed this year and will enroll five patients."

Enrollment status • Trial completion date • Trial status • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Disorders

K8 for GA: Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: University of Kentucky

New P1 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - P1 | N=5 | Recruiting | Sponsor: Michelle Abou-Jaoude | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology