Stealth Bio Stock Almost Doubles After Positive Elamipretide Data In Eye Disease Study

Stealth BioTherapeutics Corp 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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Stealth Bio Stock Almost Doubles After Positive Elamipretide Data In Eye Disease Study