The ReNEW trial will assess elamipretide for treating patients with dry age-related macular degeneration. Credit: aslysun / Shutterstock.

Stealth BioTherapeutics has enrolled the first subject in the Phase III ReNEW clinical trial as part of a clinical programme to assess elamipretide for treating patients with dry age-related macular degeneration (AMD).

The randomised, double-masked, placebo-controlled ReNEW trial will evaluate the efficacy, safety, and pharmacokinetics of once-a-day doses of elamipretide given as subcutaneous injections.

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It will involve 360 patients who will receive either a 40mg dose of elamipretide or a placebo for 96 weeks.

Participants in the ReNEW trial have the opportunity to join a Phase III open-label extension trial, ReTAIN, upon completion.

The ReNEW trial is part of a larger programme that includes the ReGAIN trial, which similarly investigates the daily subcutaneous administration of elamipretide in subjects with dry AMD.

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The rate of change in the macular area of photoreceptor loss is the primary efficacy endpoint for both trials.

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This will be measured by spectral domain optical coherence tomography (SD-OCT) and ellipsoid zone mapping at the 48-week mark.

Stealth BioTherapeutics CEO Reenie McCarthy said: “Enrolling the first patient in our Phase III programme puts us one step closer to bringing a potential first-in-class, at-home treatment option to patients living with dry AMD.

“With multiple sites now active and able to enrol patients in the US, we are off to a great start and look forward to evaluating the efficacy and safety of elamipretide in patients with dry AMD in these pivotal Phase III trials.”

In February 2021, Stealth BioTherapeutics completed subject enrolment in the Phase II ReCLAIM-2 study (SPIAM-202) of elamipretide in patients with dry AMD with geographic atrophy.