NEEDHAM, Mass., Sept. 12, 2024 /PRNewswire/ -- Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced its participation at key upcoming ophthalmology conferences to discuss the Company's clinical development efforts in dry age-related macular degeneration (dry AMD), including new analyses of the Phase 2 ReCLAIM-2 study of elamipretide and data that support the primary endpoint design of the Phase 3 ReNEW and ReGAIN studies of elamipretide.
Earlier this year, Stealth began enrolling participants in the global Phase 3 ReNEW study (NCT06373731) as part of its Phase 3 clinical program for elamipretide in patients with dry AMD. The program consists of the two Phase 3 trials, ReNEW and ReGAIN. Both trials will evaluate the efficacy, safety, and pharmacokinetics of daily subcutaneous injections of elamipretide in participants with dry AMD. The primary efficacy endpoint will measure the rate of change in the macular area of photoreceptor loss, assessed by spectral domain-optical coherence tomography (SD-OCT) and ellipsoid zone (EZ) mapping at week 48.
About Dry AMD
AMD is the leading cause of irreversible blindness and is estimated by the Vision and Eye Health Surveillance System to affect 19.8 million Americans aged 40 and older (Rein 2022), with 85% to 90% of cases being dry AMD (Schultz 2021). Dry AMD is a progressive retinal disease in which the photoreceptors, which are specialized neurons found in the retina that convert light into electrical signals required for normal visual function, suffer progressive damage and death, leading to loss of vision. Mitochondrial dysfunction, which has been associated with aging, smoking, obesity, and cardiovascular health, is known to precede clinical symptoms of AMD and increase commensurate with AMD disease progression (Feher 2006; Karunadharma 2010; Terluk 2015). Photoreceptor loss can be quantified by measuring the thickness between the EZ and retinal pigment epithelium (i.e., EZ-RPE thickness). Loss of photoreceptors cells, or EZ attenuation, has been shown to precede and predict the loss of visual function and areas of geographic atrophy in dry AMD.
About Stealth BioTherapeutics
Our mission is to develop novel therapies to improve the lives of patients living with diseases of mitochondrial dysfunction. Our lead product candidate, elamipretide, is under review for Barth syndrome and in late-stage development for primary mitochondrial myopathy and dry age-related macular degeneration. We are also evaluating a topical ophthalmic formulation of our second-generation clinical-stage candidate, bevemipretide (SBT-272), for dry age-related macular degeneration, and have a deep pipeline of novel compounds under evaluation for rare neurological and myopathic diseases.
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SOURCE Stealth BioTherapeutics Inc.