Stealth BioTherapeutics Initiates Phase 2 Clinical Study Of Elamipretide In Fuchs' Corneal Endothelial Dystrophy

BOSTON, March 8, 2016 /PRNewswire/ -- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, today announced the initiation of ReVEAL, a Phase 2 clinical study evaluating the topical eye drop formulation of elamipretide (formerly known as Ocuvia) for the treatment of patients with Fuchs' corneal endothelial dystrophy (FCED). Top-line data from the study are expected in the third quarter of 2016.

Fuchs' is a late-onset, progressive disease of the cornea characterized by a reduction of endothelial cells, and can lead to edema or even blindness in more advanced cases. Elamipretide targets the inner mitochondrial membrane to help preserve mitochondrial energetics, loss of which is thought to lead to the onset of Fuchs'.

"Many severe ocular diseases, including Fuchs', are linked to dysfunctional mitochondria and are characterized by a state of increased oxidative stress and impaired energetic components of the eye. We are aiming to safely restore these energetics and to show a clinical benefit with elamipretide in visual acuity and other functional measures," Stealth BioTherapeutics Chief Scientific Officer Mark Bamberger said. "This new trial furthers our ongoing commitment to uncovering the role mitochondrial dysfunction plays in ocular disorders, and how we might address unmet needs across several indications where impaired energetics are a final common pathway."

The Phase 2 ReVEAL study will evaluate the topical eye drop formulation of elamipretide in 16 subjects with mild to moderate corneal edema. Participants will be treated with one drop of elamipretide twice daily in the randomly selected study eye and one drop of placebo solution twice daily in the control eye for 12 weeks. The study's primary endpoints will evaluate safety and tolerability. Secondary endpoints will measure the reduction in central corneal thickness, improvement in visual acuity and change in endothelial cell count and morphology.

"Current non-surgical treatment options for Fuchs' are limited, and none of those available can actually halt or reverse the disease," said Michael B. Raizman, M.D., Ophthalmic Consultants of Boston and a primary investigator of the study. "New options are greatly needed for our armamentarium as the progressive loss of sight can be debilitating for patients."

For additional information on this study or elamipretide, please refer to Stealth's website and ClinicalTrials.gov.

About Elamipretide

Stealth's lead candidate, elamipretide (formerly known as Bendavia and Ocuvia), is an investigational drug with the potential to modify disease by preserving energetics and restoring normal energy production in mitochondria, while decreasing oxidative stress. The energetics from mitochondria maintain healthy physiology and prevent disease. This mitochondria-targeted candidate is being developed for both common and rare diseases.

Stealth BioTherapeutics: Leading Mitochondrial Medicine

Stealth BioTherapeutics is a privately held biopharmaceutical company committed to bringing mitochondrial therapies to patients to treat both common and rare diseases. Stealth's clinical development program is focused along several core therapeutic areas, including cardio-renal diseases, ophthalmic disorders and orphan mitochondrial diseases. More information regarding Stealth and its pipeline is available at StealthBT.com.

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SOURCE Stealth BioTherapeutics

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