Stealth BioTherapeutics to Showcase Leadership in Retinal Mitochondrial Health with Clinical Updates at Ophthalmic Conferences

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BOSTON, Sept. 14, 2021 -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that multiple abstracts have been accepted for presentation at several leading ophthalmic conferences this fall. These abstracts feature novel clinical findings from the positive ReCLAIM trial, which evaluated elamipretide in patients with dry age-related macular degeneration (AMD), as well as clinical updates from the ongoing ReCLAIM-2 study in patients with extrafoveal, or non-central, geographic atrophy (GA) due to dry AMD. The design and inclusion criteria for ReCLAIM-2 were informed by the positive signals in patients with extrafoveal GA enrolled in the ReCLAIM study, which also demonstrated that patients with better baseline mitochondrial health experienced greater improvements in visual function following six months of elamipretide therapy. 

"GA is a progressively blinding disease which contributes to a loss of independence for affected individuals," said Chief Executive Officer Reenie McCarthy. "Our mitochondria-targeted therapeutic approach offers the potential to not only slow the progression of retinal cell death, but to possibly reclaim visual function and associated visual quality of life. We believe that mitochondrial health is central to the bioenergetic deficit that drives downstream pathology in this devastating disease, and these data continue to support elamipretide's potential to improve visual health for patients suffering from GA."

Details of the presentations are as follows:

EURETINA 2021 Virtual Congress: September 9-12, 2021
Title: Subcutaneous Elamipretide for non-central geographic atrophy: Findings from the ReCLAIM study
Details: The pre-recorded presentation can be found on the Presentation section of Stealth's website at https://www.stealthbt.com/presentations/ 
Presenter: David Boyer, M.D.

Annual Scientific Session of The Retina Society: September 29-October 2, 2021
Title: Low-Luminance Visual Acuity and the Association of Ellipsoid Zone Integrity in Dry AMD Patients Treated with Subcutaneous Elamipretide: Post Hoc Analysis of the Phase 1 ReCLAIM-1 Study
Details: Thursday, September 30, 9:27-9:31 AM Central Daylight Time
Presenter: Dante Pieramici, M.D.

American Society of Retina Specialist (ASRS) Annual Scientific Meeting: October 8-12, 2021
Title: Safety and Efficacy of SC Elamipretide to Treat Noncentral Geographic Atrophy: ReCLAIM-1 Results and Phase II ReCLAIM-2 Baseline Characteristics
Details: Monday, October 11, 10:28–10:34 AM Central Daylight Time
Presenter: David Lally, M.D.

Title: Advanced OCT Analysis for Treatment Response Assessment for Non-neovascular AMD Treated with Subcutaneous Elamipretide from the Phase 1 ReCLAIM Study
Author: Hasan Cetin MD, Justis Ehlers MD, et. al.

American Academy of Ophthalmology (AAO) 2021: November 12-15, 2021
Title: Subcutaneous Elamipretide to Treat Non-Central Geographic Atrophy: Findings from ReCLAIM-1
Details: Presentation will be available on demand for conference attendees
Presenter: Mark Barakat, M.D.

About ReCLAIM and ReCLAIM-2

ReCLAIM-2 is a phase 2 randomized, double-masked, placebo-controlled study to evaluate the efficacy and pharmacokinetics of elamipretide in patients with dry age-related macular degeneration (AMD) with extrafoveal, or non-central, geographic atrophy (GA). The ReCLAIM-2 study completed enrollment with 176 patients. The primary endpoint of the 48-week study will measure low-luminance best-corrected visual acuity (LLVA), which assesses visual function under low light conditions meant to represent dusk or indoor (artificial) lighting. Secondary functional endpoints are change in low-luminance reading acuity and best-corrected visual acuity (BCVA), as well as patient-reported assessments of visual quality of life. Secondary imaging endpoints assessing the rate of progression of the disease include GA area as measured by fundus autofluorescence and optical coherence tomography (OCT).

ReCLAIM was a Phase 1 clinical trial which enrolled 40 patients with dry AMD with either extrafoveal, or non-central, GA or high-risk drusen to receive elamipretide therapy for 24 weeks.  The data showed improvements from baseline in LLVA and BCVA for patients with GA and drusen who completed the trial. Visual quality of life improvement under both low light and ordinary light conditions were also reported. Additionally, the rate of progression of GA was reduced relative to both the reported natural history of the disease and the six-month results reported by other agents in late-stage development.

About Stealth

We are a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction. Mitochondria, found in nearly every cell in the body, are the body's main source of energy production and are critical for normal organ function. Dysfunctional mitochondria characterize a number of rare genetic diseases and are involved in many common age-related diseases, typically involving organ systems with high energy demands such as the heart, the eye, and the brain. We believe our lead product candidate, elamipretide, has the potential to treat both rare metabolic cardiomyopathies, such as Barth syndrome, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber's hereditary optic neuropathy. We are evaluating our second-generation clinical-stage candidate, SBT-272, and our new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data. We have optimized our discovery platform to identify novel mitochondria-targeted compounds which may be nominated as therapeutic product candidates or utilized as mitochondria-targeted vectors to deliver other compounds to mitochondria.

Investor Relations
Stern Investor Relations
Janhavi Mohite, 212-362-1200
IR@StealthBT.com

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SOURCE Stealth BioTherapeutics Corp