Elamipretide hydrochloride is under clinical development by Stealth BioTherapeutics and currently in Phase II for Geographic Atrophy. According to GlobalData, Phase II drugs for Geographic Atrophy have a 29% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Elamipretide hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Elamipretide hydrochloride overview

Elamipretide hydrochloride (Bendavia) is under development for the treatment of primary mitochondrial diseases including mitochondrial myopathy, Senger syndrome, Barth syndrome, Leber’s hereditary optic neuropathy, dry age-related macular degeneration with geographic atrophy, Duchenne muscular dystrophy, Friedreich ataxia, Becker muscular dystrophy and other cardiomyopathies. It is administered through intravenous, oral, ophthalmic and subcutaneous routes. It is a new chemical entity that targets mitochondria and binds to mitochondrial membrane permeability transition pore (mPTP).
It was also under development for diseases associated with aging including acute heart failure with reduced ejection fraction (HFrEF) and preserved rejection failure (HFpEF), endothelial dysfunction induced by a single cigarette, Fuchs endothelial corneal dystrophy, acute kidney injury, ischemic reperfusion injury, diabetic macular edema, and acute coronary syndrome.

Stealth BioTherapeutics overview

Stealth BioTherapeutics Inc (Stealth BioTherapeutics), formerly Stealth Peptides International, is an early stage biotechnology company. It discovers, develops, and commercializes novel therapies for diseases and disorders associated with mitochondrial dysfunction. The company is investigating elamipretide, a peptide compound that penetrates into cell membranes, for the treatment of primary mitochondrial myopathy, barth syndrome, duchenne cardiomyopathy, and dry age-related macular degeneration. It is also evaluating SBT-272, a phase I candidate, for the treatment of rare neurodegenerative diseases. Stealth BioTherapeutics is headquartered in Grand Cayman, Cayman Islands.

For a complete picture of Elamipretide hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.