Stealth BioTherapeutics Launches Critical Patient Support Initiative

Stealth BioTherapeutics Unveils Mito Assist Program

Stealth BioTherapeutics Inc., a prominent biotechnology company specializing in innovative therapies for mitochondrial dysfunction, is proud to announce its latest initiative: the Mito Assist Patient Support Program. This program is designed specifically for patients receiving FORZINITY™ (elamipretide) injection, the first approved treatment aimed at improving muscle strength in individuals with Barth syndrome.

Forging Valuable Partnerships for Patient Care

In a significant step toward enhancing patient access, Stealth has partnered with AnovoRx Specialty Pharmacy to serve as the exclusive distributor of FORZINITY in the United States. This collaboration is central to ensuring that patients, their caregivers, and healthcare providers have the necessary support to navigate insurance coverage and access to this groundbreaking therapy.

Reenie McCarthy, the CEO of Stealth BioTherapeutics, shared her insights on the partnership: "For over a decade, Stealth has been dedicated to the Barth syndrome community. The introduction of FORZINITY is a crucial milestone, and our partnership with AnovoRx will enable us to provide a seamless experience for patients seeking access to this therapy."

Personalized Support Tailored to Patient Needs

The Mito Assist Program promises an array of tailored services aimed at assisting patients and caregivers alike. Key features of the program include:

• Co-pay assistance available for eligible patients with commercial insurance.
• Patient assistance programs aimed at those who are uninsured or underinsured.
• Guidance and training for at-home subcutaneous injection procedures.
• Dedicated support through case managers from AnovoRx to maintain ongoing communication between patients, caregivers, and healthcare providers.

Patients who are currently benefiting from elamipretide via the Expanded Access Program and meet the weight threshold of 30 kg will be directly contacted by their healthcare providers. Case managers from AnovoRx will assist these patients in transitioning smoothly to FORZINITY therapy as soon as it is available.

Accessibility and Availability of FORZINITY

Stealth BioTherapeutics anticipates that FORZINITY will be commercially available through AnovoRx by December 2025, contingent on final distribution preparations and payer coverage validation. For comprehensive information, healthcare providers and patients can reach out by calling 1-833-458-9099.

Understanding FORZINITY: Benefits, Indications, and Safety

FORZINITY (elamipretide) is an innovative cardiolipin binder indicated for enhancing muscle strength among adults and children with Barth syndrome who weigh at least 30 kg. Its rapid approval followed evidence of improved knee extensor muscle strength, marking a significant breakthrough in treatment options for this rare condition.

While the benefits are clear, healthcare professionals are urged to consider important safety information when prescribing FORZINITY. Notably, it is not recommended for neonates due to potential severe reactions associated with benzyl alcohol. Monitoring for hypersensitivity reactions is essential during treatment.

About Barth Syndrome and Its Challenges

Barth syndrome is an incredibly rare genetic disorder primarily affecting males, characterized by mitochondrial dysfunction. The condition leads to profound muscle weakness, exercise intolerance, increased fatigue, heart complications, and delayed growth. Tragically, early mortality rates are high, with many affected individuals not living beyond early childhood. Currently, there are no approved therapies in Europe for patients suffering from this syndrome.

Stealth BioTherapeutics is committed to addressing these challenges through innovative therapies that can change lives. FORZINITY's accelerated approval represents a profound advancement, not just for Barth syndrome, but potentially for other mitochondrial dysfunction-related diseases, as the company explores additional conditions such as dry age-related macular degeneration and primary mitochondrial myopathy.

About Stealth BioTherapeutics

Stealth BioTherapeutics is dedicated to creating novel therapies aimed at improving the lives of those affected by mitochondrial dysfunction. With the recent approval of FORZINITY by the U.S. FDA, Stealth has made significant strides in hematological and genetic treatments. As the company continues to innovate, it actively coordinates research for additional treatments, including bevemipretide (SBT-272), targeting neurological conditions.

Frequently Asked Questions

What is the Mito Assist Patient Support Program?

The Mito Assist Patient Support Program offers personalized support to patients and caregivers navigating insurance coverage and accessing FORZINITY.

Who is AnovoRx?

AnovoRx Specialty Pharmacy is Stealth's exclusive distribution partner for FORZINITY, providing vital support to patients and healthcare providers.

What is FORZINITY used for?

FORZINITY is a treatment indicated to improve muscle strength in patients with Barth syndrome, particularly in those weighing 30 kg or more.

How can patients access the Mito Assist Program?

Patients can get assistance through the program by contacting the designated phone line, where AnovoRx case managers will guide them.

What are the potential side effects of FORZINITY?

Common side effects include injection site reactions and serious hypersensitivity reactions which require monitoring during treatment.

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