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Stealth Biotherapeutics Expands Clinical Development for Mitochondrial Therapies

January 09, 2015

Funding grows to more than $100M

Boston, MA — January 9, 2015 — (BUSINESS WIRE) — Stealth BioTherapeutics (formerly Stealth Peptides), a clinical-stage biopharmaceutical company developing drug candidates for the treatment of diseases involving mitochondrial dysfunction, today detailed its clinical development program in both common and rare diseases for its lead compounds, Bendavia and Ocuvia. Stealth is expanding its mitochondria-targeted therapies into several core areas, including cardio-renal diseases, ophthalmic disorders and orphan mitochondrial diseases.

Stealth also announced that funding from its lead investor, Morningside, has surpassed $100M. The funding advances Stealth’s clinical development program for Bendavia and Ocuvia, and will help broaden its mitochondrial platform to include additional clinical candidates in 2015.

“With the insights of leading scientists, clinicians and patient advocates, we are aggressively pursuing the promise of our mitochondrial platform and targeted therapies in a robust development program focused on mitochondrial dysfunction,” Chief Executive Officer Travis Wilson said. “We look forward to accelerating the potential of our mitochondrial science to inform future clinical development and discovery activities.”

Stealth’s platform development and discovery activities are led by an established and seasoned senior leadership team with deep experience in cardio-renal diseases and ophthalmic disorders, and core capabilities in rare genetic mitochondrial disease.

Expanding Clinical Development Program

The clinical development of Bendavia and Ocuvia has widened to include new trials for heart failure and ophthalmic disorders, adding to its existing Phase 2 studies in acute coronary syndrome (EMBRACE-STEMI) and kidney disease. More recently, a Phase 2 study in skeletal muscle dysfunction began patient recruitment in the United States. Clinical results for Stealth’s program are anticipated to commence in the first half of 2015.

Stealth is now expanding its mitochondrial therapies to orphan diseases, including a Mitochondrial Myopathy (MM) clinical study of several inherited rare diseases. Later in the year, Stealth plans to launch a Leber’s Hereditary Optic Neuropathy (LHON) trial led by top ophthalmologists in the United States and Europe studying the disease. Lissa Poincenot, a leading LHON patient advocate, said, “We are tremendously excited for Ocuvia’s potential to treat this devastating inherited disease that causes sudden blindness, often in young adults.”

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. Bendavia and Ocuvia’s underlying science 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:
Media Relations:
dna communications
Kaitlyn Darr
Phone: (212) 445-8335
kdarr@dna-comms.com

Investor Relations:
Stern IR
Beth DelGiacco
Phone: (212) 362-1200
Beth@sternir.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