ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

The ReNEW (SPIAM-301) trial is a phase 3, randomized, double-masked, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily subcutaneous (SC) injection of elamipretide in subjects who have dry AMD. Subjects will be randomized (2:1) to once daily SC doses of 40 mg elamipretide, or placebo for 96 weeks of treatment by a central randomization and stratified by SD-OCT device type (Heidelberg SPECTRALIS®, ZEISS CIRRUS®) and baseline macular area of photoreceptor loss, defined as an ellipsoid zone-retinal pigment epithelium (EZ-RPE) thickness of 0μm assessed by SD-OCT and ellipsoid zone (EZ) mapping (High Strata ≥ 5.1mm2, Low Strata \<5.1mm2). Primary Objective * Evaluate the efficacy of once daily subcutaneous (SC) injections of elamipretide in subjects who have dry age-related macular degeneration (AMD) Secondary Objectives * Evaluate the safety and tolerability of once daily SC injections of elamipretide * Evaluate the Pharmacokinetic (PK) profile of elamipretide and its metabolites