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Stealth BioTherapeutics Announces Positive Phase 2 Clinical Trial Findings for Patients Undergoing Renal Angioplasty

November 18, 2016

Data support company’s cardiorenal program, including three ongoing heart failure trials

Single elamipretide infusion improves kidney microvasculature and function after renal artery angioplasty

BOSTON – November 18, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today presented results from the EVOLVE trial, which demonstrated that a single dose of elamipretide prior to renal artery angioplasty and stenting procedures improved kidney function and blood flow for three months post-procedure. The data were presented as a late-breaking poster at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago.

“Patients undergoing renal angioplasty and stenting, intended to open up kidney arteries blocked by atherosclerosis, often fail to regain normal kidney function due to tissue damage during the procedure, possibly due to the sudden replenishment of oxygen to starved tissues,” said Dr. Stephen Textor, the principal investigator for the trial. “The study results validate our preclinical findings and our underlying hypothesis that elamipretide may help prevent acute kidney injury by preserving mitochondrial function in cells and ultimately improve measures of kidney function in these patients.”

EVOLVE was a randomized, double-blind, placebo-controlled Phase 2a clinical trial that evaluated 14 patients ages 40 to 80 years who were scheduled for percutaneous transluminal renal angioplasty and stenting, a common procedure to enhance blood flow to the kidneys. Prior to the procedure, patients received a single intravenous dose of either elamipretide (0.05 mg/kg/hr; n=6) or placebo (n=8). The endpoints were a change in kidney function, blood flow and perfusion to the kidney.

For patients who received elamipretide, renal function as measured by eGFR was significantly improved three months after the procedure (46.5 mL/min ± 15.0) versus baseline (40.7 mL/min ± 13.4; P<0.05). For those in the placebo group, eGFR did not significantly change (34.4 mL/min ± 9.5 at baseline vs. 37 mL/min ± 10.5 at three months).

Significant improvement in kidney blood flow was also seen at three months (261 mL/min ± 115.0) vs. baseline (202 mL/min ± 129.0; P<0.05) only in the elamipretide group. Similarly, cortical perfusion was improved only in the elamipretide group (2.9 mL/min/tissue ± 1.04 at three months vs. 1.99 mL/min/tissue ± 0.8 at baseline; P<0.05). Patients who received elamipretide were also protected from a temporary lack of oxygen to kidney tissue, known as transient hypoxia, which developed 24 hours after the procedure only in the placebo group (P<0.05).

“These results provide further evidence of elamipretide’s potential to address mitochondrial dysfunction and restore cellular function across organ systems in both rare diseases and common diseases of aging,” said Stealth’s Chief Executive Officer Reenie McCarthy. “We are especially encouraged by this data in the context of our broader cardiorenal program, which includes three ongoing Phase 2 trials evaluating the potential of elamipretide to restore tissue function in heart failure. This is particularly relevant in our IDDEA-HF trial, which evaluates the cardiac and renal benefits of elamipretide in patients hospitalized due to congestive heart failure.”

For additional information on EVOLVE or elamipretide, please refer to Stealth’s website or ClinicalTrials.gov.

About Elamipretide

Stealth’s lead candidate, elamipretide, is an investigational drug with the potential to modify disease by preserving energetics and restoring normal energy production in mitochondria, while decreasing oxidative stress. The energetics from mitochondria maintain healthy physiology and prevent disease. This mitochondria-targeted candidate is being developed for both rare diseases and common diseases of aging. 

Stealth BioTherapeutics: Leading Mitochondrial Medicine

Stealth BioTherapeutics is a privately held biopharmaceutical company committed to bringing mitochondrial therapies to patients to treat both rare diseases and common diseases of aging. Stealth’s clinical development program is focused along several core therapeutic areas, including primary mitochondrial diseases, cardiorenal diseases and ophthalmic disorders. More information regarding Stealth and its pipeline is available at StealthBT.com.

Contacts

Media Relations
dna Communications
Kate Contreras, 617-520-7088
Media@StealthBT.com

Investor Relations
Stern IR
Beth DelGiacco, 212-362-1200
IR@StealthBT.com

Media Relations

dna Communications
Lindsey Colegrove, 212-537-8771
media@stealthbt.com

Investor Inquiries
Stern IR
Lauren Stival, 212-362-1200
IR@stealthbt.com