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Stealth BioTherapeutics Announces Positive Results in Bendavia Heart Failure Study: the PREVIEW Trial

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BOSTON--(BUSINESS WIRE)--

Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, today announced positive heart failure results from its PREVIEW study showing Bendavia improved cardiac function for patients. The results were presented at the European Society of Cardiology (ESC) Heart Failure Congress in Seville, Spain, during a symposium focused on mitochondria's role in chronic heart failure (CHF).

PREVIEW, a single-dose, double-blind, placebo-controlled study of CHF patients, evaluated the safety, tolerability and efficacy of Bendavia, an investigational drug targeting mitochondrial dysfunction to treat common and rare diseases. To date, standard CHF care—lowering heart rate and blood pressure—fails to address the heart's underlying energy deficit from mitochondrial dysfunction.

PREVIEW evaluated 36 CHF patients (New York Heart Association Class II and III) receiving standard care, including beta-blockers, diuretics and treatments for hypertension. Patients were randomized to 2, 20 or 80 mg doses of Bendavia or placebo in ascending, weight-adjusted, single-dose cohorts. Bendavia met its primary safety and tolerability endpoints for each dose, with linear pharmacokinetics across cohorts.

Secondary endpoints included assessments of cardiac function by echocardiography and changes in CHF biomarkers in patients receiving standard care. Bendavia improved measures of cardiac function compared to placebo across cohorts. Bendavia reduced mean end-systolic and end-diastolic volume (-18.5 and -21.5 mL versus -1.6 mL and -0.2 mL for placebo, respectively) over 24 hours in the highest dose cohort, corresponding to a peak improvement in ejection fraction (5.6%) at 12 hours. Bendavia also improved cardiac output and stroke volume, correlated with preliminary data showing reduction in CHF biomarkers, including plasma NT-proBNP.

"The improved cardiac function shown in PREVIEW demonstrates Bendavia's potential for patients," said Dr. Stefan Anker, past President of the ESC Heart Failure Association and Professor of Cardiology at University Medical Center Göttingen. Dr. Anker added, "These results reinforce the promise of Bendavia—to both complement and improve traditional heart failure care."

"Bendavia may be the new paradigm, restoring energy to the failing heart, rather than lowering heart rate and blood pressure," commented Dr. William Abraham, Director of the Division of Cardiovascular Medicine and Professor at Ohio State University, when describing Bendavia's clinical benefits in cardiac and renal diseases at the symposium. Dr. Gerasimos Filippatos, President of the ESC Heart Failure Association, led the symposium on mitochondria in CHF, which featured Drs. John Cleland, Piotr Ponikowski and Hani Sabbah speaking on Bendavia's potential in cardio-renal diseases and future clinical trials.

"Bendavia's improvement on cardiac function in both our PREVIEW and EMBRACE trials underscores its potential in heart failure," said Chief Executive Officer Travis Wilson. "We continue to broaden our cardio-renal program, initiating trials later this year to study Bendavia's benefits in this underserved patient population."

For additional information on PREVIEW or Bendavia, please refer to Stealth's website.

About Heart Failure

Heart failure afflicts more than 20 million patients worldwide and is a growing public health issue. Each year, nearly 600,000 patients in the United States are diagnosed with heart failure, leading to 300,000 annual deaths with almost $40 billion in related health care costs. Mitochondrial dysfunction is well understood as a primary contributor to the progression of heart failure in patients and is central to the underlying disease.

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 inherited 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 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 an important and 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's clinical development program is focused along several core 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 StealthBT.com.

Media Relations
dna Communications
Taylor Ramsey, 617-520-7018
Media@StealthBT.com
or
Investor Relations
Stern IR
Beth DelGiacco, 212-362-1200
IR@StealthBT.com

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