US-based biopharmaceutical company Stealth BioTherapeutics has initiated its Phase I ReCLAIM study of elamipretide to treat intermediate, dry age-related macular degeneration (AMD).
The company's lead candidate elamipretide is an investigational drug developed to modify disease by preserving energetics and restoring normal energy production in mitochondria, while decreasing oxidative stress.
The Phase I open-label ReCLAIM study is being conducted to determine the safety and tolerability of a daily subcutaneous injections of elamipretide to treat age-related macular degeneration.
AMD is a progressive eye condition causing severe vision loss as it attacks the macula of the eye, where the sharpest central vision occurs.
Dry AMD triggers breakdown or thinning of the retinal pigment epithelial cell layer in the macula, which supports the light sensitive photoreceptor cells important to vision.
Duke University Center for Macular Diseases director and professor of ophthalmology and trial investigator Dr Scott Cousins said: “There are currently no FDA-approved treatment options for dry AMD, so we are eager to better understand the effect that elamipretide may have in treating these roughly 13 million patients.
“Mitochondrial dysfunction that stems from various environmental toxins may be an important causative factor in dry AMD, and in laboratory models, elamipretide appears to prevent mitochondrial dysfunction in the retinal pigment epithelium.”
The study has enrolled patients aged 55 and above who have at least one eye with intermediate AMD, and either a high-risk protein deposits (drusen) on the retina without any geographic atrophy (GA) or GA with an unaffected central fovea (non-central GA).
The secondary endpoints of the study are to determine the baseline change in physical / ophthalmic examinations and applicability of subcutaneous injections in this patient population.
Image: Back of the eye displaying intermediate AMD. Photo: courtesy of National Eye Institute of the NIH.