Stealth BioTherapeutics to Unveil New Bevemipretide Findings at ARVO Meeting

Stealth BioTherapeutics to Present New Bevemipretide Data at ARVO Annual Meeting

Stealth BioTherapeutics Inc., a clinical-stage biotechnology firm dedicated to developing innovative treatments for diseases linked to mitochondrial dysfunction, is set to showcase promising new data regarding its next-generation ocular topical investigational drug, bevemipretide, at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, scheduled for May 4-8, 2025, in Salt Lake City.

The presentation will outline the protective effects of bevemipretide in models of dry age-related macular degeneration (AMD) and glaucoma, alongside preclinical toxicology and exposure results crucial for informing the upcoming Phase 1 study of the drug.

Reenie McCarthy, CEO of Stealth BioTherapeutics, expressed enthusiasm for the findings, stating, “We are pleased to present compelling new data further supporting the development of bevemipretide eye drops in serious ophthalmic disorders, beginning with dry AMD. Our focus is to intervene earlier in the disease’s progression when the bioenergetic mitochondrial deficits implicated in the degenerative processes might still be reversible.”

This pioneering topical treatment targeted at mitochondria is intended to restore mitochondrial structure and function, which could ultimately preserve visual function. It aims to offer a more patient-friendly approach to early disease intervention, potentially changing the landscape of treatment for ophthalmic disorders.

Upcoming Presentations

At the ARVO event, Stealth BioTherapeutics will conduct several presentations, including:
1. Oral Presentation: - Title: "Ocular topical bevemipretide targeting retinal tissue and preventing RPE cell and photoreceptor loss in a model of dry AMD"
- Details: In preclinical models of dry AMD, bevemipretide demonstrated the ability to prevent the loss of retinal pigment epithelium (RPE) cells and photoreceptors, as well as preserving the overall retinal structure and thickness.
- Presenter: Michael DiMatteo, Ph.D., Vice President of Medical Affairs, Ophthalmology
- Date/Time: May 4, 3:45 PM - 4:00 PM MT
- Location: Ballroom F

2. Poster Presentation: - Title: "Topical bevemipretide (SBT-272) eye drops in development for dry AMD: Phase 1 trial design informed by GLP study results"
- Details: Findings reveal sustained dose-dependent concentrations in target retinal tissues after topical application, with safety findings identified as non-adverse and largely reversible following a four-week recovery.
- Presenter: Anthony Abbruscato, Pharm.D., Senior Vice President of Clinical Development
- Date/Time: May 5, 3:00 PM - 4:45 PM MT
- Location: Poster Hall

3. Poster Presentation: - Title: "Neuroprotective Effects of Topical Bevemipretide in a Rodent Model of Glaucoma"
- Details: In a preclinical glaucoma model, bevemipretide was shown to protect retinal ganglion cells and maintain visual function as measured by reflex testing.
- Presenter: Nolan R. McGrady, Ph.D., Associate Basic Scientist, Vanderbilt University Medical Center
- Date/Time: May 6, 1:15 PM - 3:00 PM MT
- Location: Poster Hall

Understanding Dry AMD

AMD represents a leading cause of blindness among older adults, impacting approximately 20 million Americans. The majority of these cases (85% to 90%) present as dry AMD, a progressive condition resulting in the deterioration of photoreceptors essential for vision. Mitochondrial dysfunction plays a critical role in disease progression, exacerbated by factors such as aging and lifestyle. Consequently, addressing bioenergetic deficits has become a focal point in developing treatments aimed at preserving vision and restoring mitochondrial health.

About Stealth BioTherapeutics

Stealth BioTherapeutics strives to improve the lives of patients suffering from diseases arising from mitochondrial dysfunction, with its lead product candidate, elamipretide, currently undergoing review for Barth syndrome and advancing in clinical trials for other conditions, including dry AMD. The company is at the forefront of innovation, exploring a topical formulation of its second-generation candidate, bevemipretide, to combat dry AMD effectively. They maintain a robust pipeline of novel compounds intended for rare neurological, cardiac, and myopathic diseases.

As the ARVO Annual Meeting approaches, the potential impact of Stealth BioTherapeutics’ work could be significant, signaling new advancements in the treatment of vision disorders linked to mitochondrial dysfunction.