Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the presentation of new data from a post hoc analysis of the Phase 1 ReCLAIM study evaluating elamipretide in patients with non-central geographic atrophy (GA) and high risk drusen associated with dry age-related macular degeneration (AMD). The data, presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting, showed that for patients with GA treated with elamipretide for 24-weeks, improvements from baseline in low light visual acuity (LLVA), which is the primary efficacy endpoint in Stealth's fully enrolled Phase 2 ReCLAIM-2 trial, were significantly correlated to baseline assessments of mitochondrial health in the ellipsoid zone (EZ). The EZ is a mitochondria-rich area of the retina which supports photoreceptor function and is attenuated in dry AMD. EZ imaging assessments were conducted using optical coherence tomography (OCT) and included pan-macular EZ-retinal pigment endothelium cell (RPE) volume and macular percentage of EZ-RPE attenuation. Improvements in LLVA were significantly correlated to both baseline EZ-RPE volume and EZ-RPE attenuation, with eyes gaining two or more lines showing significantly less EZ-RPE attenuation and percentage area of macular GA at baseline.
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