Biotechnology company Stealth Biotherapeutics (“Stealth”) has made the company’s mission to develop and commercialize treatments for patients with diseases characterized by mitochondrial dysfunction. One leading treatment in the company’s pipeline is elamipretide, which Stealth believes has the potential to treat conditions from Duchenne muscular dystrophy (DMD) to dry macular degeneration.

In a press release, Stealth shared that the company’s ReCLAIM-2 clinical trial, which will evaluate the safety, efficacy, tolerability, and pharmacokinetics of elamipretide for patients with dry age-related macular degeneration, is fully enrolled. In particular, the trial will evaluate the drug for patients with geographic atrophy. Elamipretide received Fast Track designation for this condition in 2018.

According to the BrightFocus Foundation, geographic atrophy:

refers to regions of the retina where cells waste away and die (atrophy). Sometimes these regions of atrophy look like a map to the doctor who is examining the retina, hence the term geographic atrophy.

This usually occurs in later stages of the disease. Altogether, 176 patients enrolled in the clinical trial. During the trial, researchers will evaluate changes in vision sharpness under low-light conditions, reading ability in low light conditions, and best-corrected vision. Researchers will also examine how the geographic atrophy area spreads or changes.

Macular Degeneration

A combination of genetics and environmental factors are thought to cause macular degeneration, an eye disease which causes vision loss. There are two forms of macular degeneration: dry and wet. Ultimately, wet is the more severe form and accounts for 10-15% of all cases. It occurs when abnormal blood vessels grow under the retina, leaking blood or fluids. Eventually, this causes ocular scarring and vision loss. Alternately, the dry version makes up around 85-90% of diagnoses. In dry macular degeneration, the macula begins to grow thinner with age. Drusen, or small groups of proteins, grow in the eyes. There are no approved therapies for the dry form of this condition.

In both wet and dry forms, the macula begins to deteriorate. Ultimately, this leads to vision difficulties, including changes in the ability to read, see color or fine detail, recognize faces, or drive. Other symptoms included blurred vision or difficulty seeing in low light. Risk factors include age (55+), a family history of macular degeneration, smoking, or being Caucasian.

Learn more about macular degeneration here.