Stealth Bio Stock Almost Doubles After Positive Elamipretide Data In Eye Disease Study
- Stealth BioTherapeutics Corp (NASDAQ: MITO) shares soared in the premarket session in reaction to new data from a post hoc analysis of Phase 1 ReCLAIM study evaluating elamipretide in patients with noncentral geographic atrophy (GA) and high-risk drusen associated with dry age-related macular degeneration (AMD).
- The data were presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting.
- The study showed that for patients with GA treated after elamipretide treatment for 24-weeks, improvements from baseline in low light visual acuity (LLVA) 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.
- In the Noncentral GA subgroup (n=19) mean BCVA at baseline was 73.7 letters, and the mean baseline LLVA was 43.9 letters. At week 24, there was a mean increase in BCVA of 4.6±5.1 letters from baseline, with a mean increase in LLVA of 5.4±7.9 letters from baseline.
- In the High-Risk Drusen Subgroup (n=21), mean BCVA at baseline was 79.4 letters, and mean baseline LLVA was 63.7 letters.
- At week 24, there was a mean increase in BCVA of 3.6±6.4 letters from baseline, with a mean increase in LLVA of 5.6±7.8 letters from baseline.
- The visual quality of life improvement under both low light and ordinary light conditions was also reported.
- The company is also conducting a 48-Week study, ReCLAIM-2, to evaluate the efficacy and pharmacokinetics of elamipretide in patients with dry AMD with GA. Data read-out is expected in early next year.
- See the presentation here.
- Price Action: MITO shares jumped 79.2% at $2.14 in the premarket session on the last check Thursday.
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