Stealth BioTherapeutics has completed enrolment in the Phase II ReCLAIM-2 study (SPIAM-202) of its lead product candidate, elamipretide, in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA).
A progressive eye condition, AMD is a major cause of blindness in adults.
The randomised, double-masked, placebo-controlled study will analyse the efficacy and pharmacokinetics of elamipretide in AMD patients with GA. A total of 176 patients have been enrolled in the ReCLAIM-2 study.
Stealth BioTherapeutics CEO Reenie McCarthy said: “We believe that mitochondria-targeted therapeutics offer a differentiated approach to treat diseases of ageing, such as dry AMD, which significantly affects the independence of over a million elderly patients.
“By targeting the bioenergetic deficits that drive pathology in this disease, we hope to improve visual function for affected patients.
“Completing enrollment of this trial represents a meaningful milestone in our mission to improve the health-span of patients suffering from diseases of aging and also fulfills the condition for additional funding ($10m) under the Development Funding Agreement announced in October 2020.”
The primary endpoint of the 48-week study will evaluate low-luminance best-corrected visual acuity that analyses visual function under low light conditions, which represent dusk or indoor (artificial) lighting.
Change in low-luminance reading acuity, best-corrected visual acuity (BCVA) will form the secondary functional endpoints.
The rate of disease progression will be the secondary imaging endpoints, which include GA area as analysed by fundus autofluorescence and optical coherence tomography.
The company anticipates reporting top-line data in the first half of next year.
In July 2017, Stealth started a Phase II/III TAZPOWER clinical trial to investigate its product candidate elamipretide to treat patients with Barth syndrome caused by TAZ gene mutations.