Stealth Bio Posts Disappointing Elamipretide Data From Mid-Stage Geographic Atrophy Study

Stealth BioTherapeutics Corp MITO has announced topline data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in geographic atrophy (GA) secondary to dry age-related macular degeneration.
Although the trial did not meet its primary endpoints, a key secondary endpoint showed that elamipretide categorically improved visual function for patients with GA.
The study did not meet the primary endpoints of mean change in low luminance visual acuity (LLVA) and geographic atrophy (GA) progression.
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Additionally, elamipretide demonstrated proof of mechanism by reducing progressive ellipsoid zone loss, a key biomarker of retinal mitochondrial health.
Elamipretide resulted in a two or more line gain in LLVA for greater than 15% of patients completing the 48-week trial (p=0.04).
Although this improvement in visual function was not associated with reduced GA progression (primary endpoint), a significant reduction in ellipsoid zone loss (p=0.0034) was observed.
Elamipretide was generally well tolerated in ReCLAIM-2. Injection site reactions were the most commonly observed adverse events and, in some cases, led to early termination.
Price Action: MITO shares are down 23.40% at $0.31 during the premarket session on the last check Monday.