NEEDHAM,
Mass., May 1, 2024 /PRNewswire/ -- Stealth
BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage
biotechnology company focused on the discovery, development and
commercialization of novel therapies for diseases involving
mitochondrial dysfunction, today announced its participation at key
upcoming ophthalmology conferences to discuss the Company's
clinical development efforts in dry age-related macular
degeneration (dry AMD), including progression of lead
investigational compound elamipretide into Phase 3 trials and
development of pipeline compound bevemipretide (SBT-272) as a
topical ophthalmic drop.
- At the OIS Retina Innovation Summit (OIS), Reenie McCarthy, Stealth's Chief Executive
Officer, will participate from 12:00 p.m.–12:50 p.m. PT in a panel
discussion entitled "Spotlight on Dry AMD & GA." OIS is being
held on Saturday, May 4th at the Four
Seasons Hotel in Seattle, WA.
- At the Association for Research in Vision and
Ophthalmology (ARVO) annual meeting, the Company will present a
poster titled, "Next-generation Ocular Topical SBT-272 Demonstrates
Optimized Retina Tissue Exposure: Building Upon Elamipretide for
Treating Dry AMD." ARVO is being held May
5-9 in Seattle, WA.
- At Retina World Congress (RWC), Reenie McCarthy will participate in "Retina
Unplugged: Designing Clinical Studies within the FDA Guidance"
moderated by Dr. Baruch D. Kuppermann from 8:05 a.m.– 8:35 a.m. on May
9th. RWC is being held May
9-12 at the Fort Lauderdale Marriott Harbor Beach
Hotel.
The upcoming presentations emphasize Stealth's commitment to
develop its mitochondrial targeted investigational products to
address the bioenergetic deficit contributing to disease pathology
and vision loss in dry AMD. Stealth plans to initiate two global
Phase 3 trials, ReNEW and ReGAIN, to evaluate the efficacy, safety
and pharmacokinetics of subcutaneous injections of elamipretide in
subjects with dry AMD, with first patient enrollment expected this
quarter. Stealth is also advancing preclinical development of
bevemipretide (SBT-272) for topical application, with Phase 1
initiation expected around year-end.
About ReNEW and ReGAIN
ReNEW and ReGAIN are two
identical global research studies evaluating the efficacy of
once-daily subcutaneous injections of elamipretide in subjects who
have dry AMD. The duration of the research studies will consist of
a masked treatment period of 96 weeks with the option for
participants to enroll in the open-label extension trial, ReTAIN.
The primary endpoint for the trials is the rate of change in the
macular area of photoreceptor loss, defined as an ellipsoid zone to
retinal pigment epithelium thickness of 0μm. The macular area of
photoreceptor loss will be assessed by spectral domain-optical
coherence tomography and ellipsoid zone mapping. In both trials,
360 patients will be treated in a 2:1 randomization with either
elamipretide or placebo for 96 weeks.
About Stealth BioTherapeutics
Stealth BioTherapeutics
is a clinical-stage biotechnology company focused on the discovery,
development, and commercialization of novel therapies for
age-related and rare genetic diseases involving mitochondrial
dysfunction. The Company is initiating Phase 3 clinical trials of
elamipretide, its lead investigational product candidate, in dry
age-related macular degeneration. Elamipretide is also being tested
in a fully enrolled Phase 3 clinical trial in primary mitochondrial
myopathy, a rare skeletal myopathic disease, and is under review by
the Food and Drug Administration for Barth syndrome, an ultra-rare
cardioskeletal disease. The Company is developing its
second-generation clinical-stage candidate, bevemipretide
(SBT-272), for ophthalmic and neurological disease indications. The
Company has a deep pipeline of novel mitochondria-targeted
compounds under evaluation as therapeutic product candidates.
Investor Contact
Stern Investor Relations
Austin Murtagh
Austin.Murtagh@sternir.com
Media Contact
Anna Stallman Communications
Anna Stallman
anna@annacomms.com
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SOURCE Stealth BioTherapeutics Inc.