BOSTON, May 17, 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, today announced that it has reached agreement with Morningside Ventures for Morningside to provide $30 million of additional payments to the Company during 2021 under its existing Development Funding Agreement. The payments will be paid to the Company in three tranches.
The additional payments were triggered by new positive analyses of clinical data from the ReCLAIM Phase 1 trial, announced on May 5, 2021, which associated baseline mitochondrial viability with improvements in vision for patients with geographic atrophy.
The Company also previously announced a new data analysis from its MMPOWER-3 Phase 3 clinical trial, which identified responders among patients with primary mitochondrial disease due to nuclear DNA mutations (nPMD), and plans to initiate a Phase 3 clinical trial in patients with nPMD based on these results.
“We are encouraged that Morningside shares our enthusiasm about these recent findings from our geographic atrophy and nPMD programs, which we believe will allow us to enrich our future studies in these indications,” said Reenie McCarthy, CEO of Stealth. “This additional funding will allow us to initiate a Phase 3 clinical trial evaluating the impact of elamipretide in patients with nPMD as well as continue our work on an intravitreal formulation to inform Phase 3 formulation decisions as we await data from our ongoing ReCLAIM-2 trial in geographic atrophy early next year.”
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, Duchenne muscular dystrophy and Friedreich’s ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, such as POLG-related disorders, 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, for rare neurodegenerative disease indications following promising preclinical data in amyotrophic lateral sclerosis, or ALS. 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.
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