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Stealth BioTherapeutics Presents at NIH Acute Kidney Injury Outcomes Meeting: Bendavia Clinical Results Highlighted During Industry Panel

February 23, 2015

Leading Nephrologists Convene to Advance Novel Therapies, Translational Research and Clinical Trials for AKI

Boston, MA — February 23, 2015 — Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing drug candidates for the treatment of diseases involving mitochondrial dysfunction, today announced interim Phase 2 clinical results with Bendavia in its cardio-renal program. Bendavia’s results in an acute kidney injury (AKI) trial were featured during the Industry Panel at the first National Institutes of Health AKI Outcomes Meeting in Bethesda, Maryland. The meeting was led by the National Institute of Diabetes & Digestive & Kidney Disease (NIDDK), one of the largest institutes at the NIH.

Stephen Textor, M.D., principal investigator for Stealth’s Phase 2 AKI trial, presented data with Bendavia in chronic kidney disease (CKD) patients at risk of AKI due to interventions involved in treating renovascular hypertension. Bendavia’s clinical results demonstrated an improvement in long-term renal blood flow and cortical perfusion, correlating with a statistically significant decrease in serum creatinine.

“The problem in many kidney treatments is that, as we restore blood flow, the mitochondrial injury that occurs is toxic to the kidney. To be able to block that is key,” commented Dr. Textor. “I don’t know anyone in the field of kidney disease who, as they have begun to appreciate the potential to stabilize cells and prevent mitochondrial injury, isn’t very excited about this.”

Dr. Textor’s findings and growing research underscore the role of mitochondrial dysfunction in cardio-renal diseases. Preserving and restoring mitochondrial function in these patients represents a novel therapeutic approach. Bendavia is an investigational drug that targets the inner mitochondrial membrane to treat diseases both common and rare, including orphan mitochondrial and cardio-renal diseases such as CKD, diabetic nephropathy and heart failure. In nonclinical studies, Bendavia has been shown to modify disease progression by restoring cellular energetics and function.

AKI is one of the most common and devastating in-hospital complications for patients. The incidence of AKI has nearly doubled during the past decade, yet there remain no FDA-approved treatments. For patients suffering from the most severe AKI cases, the rates of dialysis and mortality continue to climb.

“We are pleased to join these internationally-recognized nephrologists, researchers and industry leaders assembled by the NIH,” said Chief Executive Officer Travis Wilson. “The community’s understanding of the role of mitochondrial dysfunction in kidney disease continues to develop alongside our research,” he added. “We look forward to advancing our clinical studies in cardio-renal diseases, including AKI, with an aim toward offering a potential life-changing therapy to this underserved patient population.”

Mitochondria, The Cell’s Powerhouse

Mitochondria are the cell’s powerhouse, responsible for more than 90% of the energy our bodies need to sustain life and support growth. The energetics from mitochondria maintain healthy physiology and prevent disease. In many common and rare diseases, dysfunctional mitochondria are a key component of disease progression.

About Bendavia™ and Ocuvia™

Stealth’s lead candidates, Bendavia and Ocuvia, are investigational drugs with the potential to modify disease through mitoprotection—the ability to preserve energetics and restore normal energy production in mitochondria, while decreasing oxidative stress. These clinical candidates are being developed for both common and rare diseases including mitochondrial diseases where there are no FDA-approved treatments. The underlying science of Bendavia and Ocuvia is supported by more than 100 independent, peer-reviewed publications and abstracts. These mitochondrial-targeted candidates represent a novel therapeutic approach with the potential to address a wide variety of diseases having unmet treatment needs.

Stealth BioTherapeutics: Leading Mitochondrial Medicine

Stealth BioTherapeutics is a privately held biopharmaceutical company committed to bringing mitochondria therapies to patients to treat both common and rare diseases. As a key common element in a variety of serious, debilitating diseases, mitochondria – the cell’s energy source – offer a promising, and yet untapped, target to modify diseases with significant unmet treatment needs. Stealth is expanding its clinical development program to additional therapeutic areas, including cardio-renal diseases, ophthalmic disorders and orphan mitochondrial diseases. By defining the broad potential of its mitochondrial platform and therapies, Stealth is leading mitochondrial medicine.

More information regarding Stealth and its pipeline is available at www.stealthBT.com.

 

Contact:
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Taylor Ramsey
Phone: (617) 520-7018
Media@StealthBt.com

Investor Relations:
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Beth DelGiacco
Phone: (212) 362-1200
IR@StealthBT.com

Media Relations

dna Communications
Kate Contreras, 617-520-7088
media@stealthbt.com

Investor Inquiries
Stern IR
Rachel Frank, 212-362-1200
IR@stealthbt.com