Stealth BioTherapeutics Corp (NASDAQ: MITO) is screaming for the top in the market this morning, and for good reason. The company announced that it showcased positive data at the 2021 Association for Research in Vision and Ophthalmology Virtual Annual Meeting. Here’s what’s going on:
MITO Stock Climbs On Data
The data the company presented proved to be overwhelmingly positive. It showed that for patients with dry AMD with non-central geographic atrophy (GA) treated with elamipretide for 24 weeks, saw improvements from baseline in low light visual acuity, the primary endpoint of the company’s Phase 2 clinical trial.
Moreover, the company showed positive data in patients with dry AMD.
It’s also worth mentioning that the treatment is proving to be safe and well-tolerated among the patient population in the clinical trial.
In a statement, Dr. Justis Ehlers, the Norman C. and Donna L. Herbert Endowed Chair of Ophthalmic Research at Cole Eye Institute at Cleveland Clinic, had the following to offer:
Based on the data presented showing an association between outer retinal features and treatment response to elamipretide, this approach to imaging biomarker interrogation may provide a unique opportunity for clinical trial enrichment and identification of eyes that are more likely to benefit from treatment.
These findings may suggest that there may be a ‘retinal reserve’ that is required and potentially measurable that provides a greater chance at treatment response.
The above statement was followed up by Rennie McCarthy, CEO at MITO, with the statement below:
It is exciting to confirm the relationship between elamipretide-mediated improvements in visual function and mitochondrial health in patients suffering from progressive vision loss due to GA. These data support our confidence in our ReCLAIM-2 trial design, which focuses on the earlier stages of GA before irreversible mitochondrial and RPE damage is thought to have occurred. We are encouraged to learn that intervening at this stage of the disease may not only slow disease progression, but also restore visual function and visual quality of life to patients suffering from this life-limiting disease. These learnings may also offer potential enrichment strategies to inform Phase 3 trial design following read-out of our ReCLAIM-2 data early next year.
The Bottom Line
The bottom line here is simple, Stealth BioTherapeutics may be onto something big here. The data is showing a significantly positive response to the company’s treatment in an extremely high value indication. In fact, by 2025, it’s expected that the dry AMD market will climb to be worth more than $12 billion annually.
All Stealth BioTherapeutics would have to do to make significant revenue is tap into a small percentage of this market, and considering the positive Phase 2 data, the company may not be too far off. All told, MITO stock is one to watch closely.