- Stealth BioTherapeutics Corp (NASDAQ: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.
