Stealth BioTherapeutics enrolls first patient in global Phase 3 clinical program for elamipretide in patients diagnosed with dry AMD

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The primary endpoint for the ReNEW and ReGAIN trials is the rate of change in the macular area of photoreceptor loss assessed by spectral domain-optical coherence tomography (SD-OTC) and ellipsoid zone mapping at week 48.

Image credit: AdobeStock/Jioo7

(Image credit: AdobeStock/Jioo7)

Stealth BioTherapeutics Inc announced it has enrolled and dosed its first patient in the ReNEW trial (NCT06373731) as part of its Phase 3 clinical program for elamipretide in patients with dry age-related macular degeneration (dry AMD).

According to a news release, the clinical program includes the 2 Phase 3 trials, ReNEW and ReGAIN. Both trials will evaluate the efficacy, safety, and pharmacokinetics of daily subcutaneous injections of elamipretide in participants with dry AMD.1

ReNEW and ReGAIN are Phase 3 global clinical trials evaluating the efficacy and safety of once-daily subcutaneous injections of elamipretide in participants with dry AMD.

The company noted in its news release that the primary endpoint for the trials is the rate of change in the macular area of photoreceptor loss assessed by spectral domain-optical coherence tomography (SD-OTC) and ellipsoid zone mapping at week 48.1

In the ReNEW trial, 360 patients will be randomized 2:1 to either elamipretide or placebo for 96 weeks with the option for participants to enroll in the open-label extension trial, ReTAIN.

“Enrolling the first patient in our Phase 3 program puts us one step closer to bringing a potential first-in-class, at-home treatment option to patients living with dry AMD,” CEO Reenie McCarthy said in the news release. “With multiple sites now active and able to enroll patients in the U.S., 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 3 trials.”

Charles Wykoff, MD, PhD, from Retinal Consultants of Texas, pointed out in the news release that there is an unmet need for new therapies with differentiated mechanisms of action to treat dry AMD, especially those that could be readily employed for the management of earlier stages of disease.

“Elamipretide, a mitochondrial targeted therapy, can be self-administered by patients at home,” he said in a statement. “It holds the potential to be a transformative approach to dry AMD management by targeting the bioenergetic imbalance implicated in the progressive loss of photoreceptors that defines AMD and leads to progressive visual decline.”

Reference:
  1. Stealth BioTherapeutics Announces First Patient Enrolled in Global Phase 3 Clinical Program for Elamipretide in Patients with Dry Age-Related Macular Degeneration - Stealth BioTherapeutics Inc. stealthbt.com. Published June 5, 2024. Accessed June 6, 2024. https://stealthbt.com/stealth-biotherapeutics-announces-first-patient-enrolled-in-global-phase-3-clinical-program-for-elamipretide-in-patients-with-dry-age-related-macular-degeneration/
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