BOSTON, Nov. 14, 2016 /PRNewswire/ -- Stealth BioTherapeutics ( Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of ReCLAIM, a Phase 1 study evaluating elamipretide in intermediate age-related macular degeneration (AMD). Top-line data are expected mid-year 2017.
"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," said Dr. Scott Cousins, the trial investigator, and Professor of Ophthalmology and Director of the Duke University Center for Macular Diseases. "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." ReCLAIM is an open-label study to evaluate the safety and tolerability of 12 weeks' treatment with daily subcutaneous injections of elamipretide in patients, age 55 and above who have at least one eye with intermediate AMD, and have either: a) high-risk protein deposits (drusen) on the retina without any geographic atrophy (GA), a characteristic of advanced AMD which can result in the loss of photoreceptor cells or b) GA with an unaffected central fovea (noncentral GA). The study's primary endpoints are safety and tolerability, and the secondary endpoints are changes from baseline in physical/ophthalmic examinations and feasibility of subcutaneous injections in this patient population. "ReCLAIM will build upon our ongoing ophthalmic program to help us better understand the potential of elamipretide to treat back of the eye diseases as well as the effects of the treatment to slow the aging process in eye tissue," said Stealth Chief Executive Officer Reenie McCarthy. "We look forward to evaluating initial results of this study mid-year 2017." For additional information on ReCLAIM or elamipretide, please refer to Stealth's website and ClinicalTrials.gov. About Age-Related Macular DegenerationAge-related macular degeneration (AMD) is a progressive eye condition which affects approximately 15 million people in the U.S., and escalates with age. AMD causes severe vision loss because it attacks the macula of the eye, where the sharpest central vision occurs. There are two types of AMD: wet and dry. Wet AMD affects only 10-15% of those with the condition and is characterized by the breaking of the membrane underlying the retina. Dry is the most common type of macular degeneration, but has no FDA-approved treatment options. Dry AMD is characterized by a breakdown or thinning of the retinal pigment epithelial cell layer in the macula - which supports the light sensitive photoreceptor cells critical to vision. There are three stages of AMD (early, intermediate and late) defined by the size and number of drusen under the retina, among other factors. Intermediate AMD currently affects up to eight million patients aged 40+ in the U.S.