Stealth BioTherapeutics announced that it has dosed the first patient in ReCLAIM-2, a phase 2 study of elamipretide in patients with dry age-related macular degeneration (AMD) with geographic atrophy.
“People with dry AMD can ultimately lose central vision. However, long before that point, they suffer from very impaired vision under low light conditions and at night. Both types of vision loss have a very negative impact on mobility and quality of life,” Dr. Scott Cousins, trial investigator and Professor of Ophthalmology and Director of the Duke University Center for Macular Diseases, said in a company news release. “Given there are no therapies approved for this debilitating disease, we are eager to learn more about the potential of elamipretide in this setting.”
In November 2018, the FDA granted Fast Track designation for elamipretide for patients with dry AMD with geographic atrophy.
“Mitochondrial dysfunction has been implicated in the pathogenesis of dry AMD, leading to early failure of the highly energy-dependent photoreceptors responsible for night vision,” said Chief Executive Officer Reenie McCarthy. “We were pleased to see gains in patients’ low light vision during our phase 1 trial, suggesting that elamipretide may help improve visual function for patients suffering from this blinding disease. The initiation of ReCLAIM-2 is an important milestone in our efforts to combat this devastating disease of aging.”
ReCLAIM-2 is a double-masked, placebo-controlled, multicenter clinical trial involving approximately 180 subjects with non-central geographic atrophy in at least one eye. Subjects will be randomized 2 to 1 to either elamipretide or placebo, and will receive a 40 mg once-daily injection of elamipretide or placebo for a 48-week period. The study will evaluate safety, efficacy and pharmacokinetics of subcutaneous injections of elamipretide, and its primary endpoints are safety and tolerability, and changes from baseline in low-luminance best-corrected visual acuity.
For additional information on the ReCLAIM-2 study or elamipretide, refer to Stealth’s website and ClinicalTrials.gov.