Aurion Biotech Announces First Canadian Subject Dosed in Phase 1 / 2 Clinical Trial
March 28 2024 - 8:21AM
Business Wire
Allogeneic Cell Therapy for the Treatment
of Corneal Edema Secondary to Corneal Endothelial
Dysfunction
Aurion Biotech, whose mission is to restore vision to millions
of patients with life-changing regenerative therapies, today
announced that it has dosed the first Canadian subject in its Phase
1 / 2 clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for
the treatment of corneal edema secondary to corneal endothelial
dysfunction.
“We are very pleased to have begun dosing subjects in this trial
in Canada,” said Michael Goldstein, MD, MBA, President and Chief
Medical Officer of Aurion Biotech. “Treating subjects in both the
United States and Canada in our CLARA trial is an important
milestone in our clinical development program. We believe that our
cell therapy has the potential to revolutionize the treatment of
corneal patients throughout the world.”
AURN001 is a combination cell therapy product (biologic/drug)
comprised of neltependocel (allogeneic human corneal endothelial
cells [CECs]) and Y-27632 (an inhibitor of Rho-associated,
coiled-coil containing protein kinase [ROCK]). AURN001 is intended
to be administered to the eye as a one-time, intracameral
injection. The Phase 1 / 2 clinical trial (ABA-1, CLARA) is a
prospective, multi-center, randomized, double masked, parallel-arm
cell dose-ranging clinical trial in subjects with corneal edema
secondary to corneal endothelial dysfunction. The study will
evaluate three different doses of neltependocel used in combination
with Y-27632. Approximately 100 subjects will be randomized in
sites in the U.S. and in Canada.
This trial is designed to assess the safety, tolerability, and
efficacy of AURN001 for the treatment of corneal edema secondary to
corneal endothelial dysfunction. The primary endpoint is the
percentage of subjects who gain 3 lines of vision at 6 months.
About Corneal Endothelial Dysfunction
Corneal edema secondary to endothelial dysfunction is a
sight-threatening and debilitating condition affecting millions of
people throughout the world. When corneal endothelial cells die or
degrade, they do not regenerate. If left untreated, corneal
endothelial cell loss can cause corneal edema (swelling) and loss
of vision. Although corneal transplants are effective, there are
disadvantages with these procedures – PKP/DMEK/DSAEK – including
limited donor organ supply. Transplants require a supply of donor
corneas in a 1:1 ratio (one healthy donor cornea to treat each
diseased one), yet it’s estimated that there is only one donor
cornea available for every 70 diseased eyes.1 In addition,
post-operative recovery for corneal transplant patients requires
that they lie flat on their backs for up to three days, in order
for the transplant to adhere to the corneal stroma.
About Aurion Biotech
With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is
a clinical-stage biotech company, whose mission is to restore
vision to millions of patients with life-changing regenerative
therapies. Aurion Biotech is the recipient of the prestigious Prix
Galien award for best start-up in biotech. The Company’s first
candidate is for the treatment of corneal edema secondary to
corneal endothelial disease, and is the first off-the-shelf,
clinically validated cell therapy for corneal care, having received
regulatory approval in Japan. The Company has initiated clinical
trials in the U.S. and Canada. Privately held, Aurion Biotech is
backed by leading investors that include Deerfield, Alcon,
Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary
Ventures. To learn more about Aurion Biotech, visit
www.aurionbiotech.com.
_______________
1https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2474372
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240328939779/en/
Judith McGarry (corporate communications) 415-971-2900
judith.mcgarry@aurionbiotech.com
Michele Gray (ophthalmology media) 917-449-9250
michele@mgraycommunications.com
Beth Keshishian (biotech & business media) 917-912-7195
beth@bethkeshishian.com