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NEEDHAM, Mass., May 1, 2024 /PRNewswire/ -- Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced its participation at key upcoming ophthalmology conferences to discuss the Company's clinical development efforts in dry age-related macular degeneration (dry AMD), including progression of lead investigational compound elamipretide into Phase 3 trials and development of pipeline compound bevemipretide (SBT-272) as a topical ophthalmic drop.

• At the OIS Retina Innovation Summit (OIS), Reenie McCarthy, Stealth's Chief Executive Officer, will participate from 12:00 p.m.–12:50 p.m. PT in a panel discussion entitled "Spotlight on Dry AMD & GA." OIS is being held on Saturday, May 4th at the Four Seasons Hotel in Seattle, WA.
• At the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, the Company will present a poster titled, "Next-generation Ocular Topical SBT-272 Demonstrates Optimized Retina Tissue Exposure: Building Upon Elamipretide for Treating Dry AMD." ARVO is being held May 5-9 in Seattle, WA.
• At Retina World Congress (RWC), Reenie McCarthy will participate in "Retina Unplugged: Designing Clinical Studies within the FDA Guidance" moderated by Dr. Baruch D. Kuppermann from 8:05 a.m.– 8:35 a.m. on May 9th. RWC is being held May 9-12 at the Fort Lauderdale Marriott Harbor Beach Hotel.

The upcoming presentations emphasize Stealth's commitment to develop its mitochondrial targeted investigational products to address the bioenergetic deficit contributing to disease pathology and vision loss in dry AMD. Stealth plans to initiate two global Phase 3 trials, ReNEW and ReGAIN, to evaluate the efficacy, safety and pharmacokinetics of subcutaneous injections of elamipretide in subjects with dry AMD, with first patient enrollment expected this quarter. Stealth is also advancing preclinical development of bevemipretide (SBT-272) for topical application, with Phase 1 initiation expected around year-end.

About ReNEW and ReGAIN
ReNEW and ReGAIN are two identical global research studies evaluating the efficacy of once-daily subcutaneous injections of elamipretide in subjects who have dry AMD. The duration of the research studies will consist of a masked treatment period of 96 weeks with the option for participants to enroll in the open-label extension trial, ReTAIN. The primary endpoint for the trials is the rate of change in the macular area of photoreceptor loss, defined as an ellipsoid zone to retinal pigment epithelium thickness of 0μm. The macular area of photoreceptor loss will be assessed by spectral domain-optical coherence tomography and ellipsoid zone mapping. In both trials, 360 patients will be treated in a 2:1 randomization with either elamipretide or placebo for 96 weeks.

About Stealth BioTherapeutics
Stealth BioTherapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for age-related and rare genetic diseases involving mitochondrial dysfunction. The Company is initiating Phase 3 clinical trials of elamipretide, its lead investigational product candidate, in dry age-related macular degeneration. Elamipretide is also being tested in a fully enrolled Phase 3 clinical trial in primary mitochondrial myopathy, a rare skeletal myopathic disease, and is under review by the Food and Drug Administration for Barth syndrome, an ultra-rare cardioskeletal disease. The Company is developing its second-generation clinical-stage candidate, bevemipretide (SBT-272), for ophthalmic and neurological disease indications. The Company has a deep pipeline of novel mitochondria-targeted compounds under evaluation as therapeutic product candidates.

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Stern Investor Relations
Austin Murtagh
Austin.Murtagh@sternir.com

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Anna Stallman
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SOURCE Stealth BioTherapeutics Inc.