Aurion Biotech has announced the completion of dosing for all participants in the Phase I/II CLARA clinical trial of allogeneic cell therapy, AURN001, aimed at treating corneal oedema secondary to endothelial dysfunction.
AURN001 combines neltependocel, allogeneic human corneal endothelial cells, with Y-27632, a ROCK inhibitor, and is administered as a one-time intracameral injection to the eye.
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The prospective, multicentre, randomised, double-masked, parallel-arm cell dose-ranging study will assess the safety, tolerability, and efficacy of the cell therapy.
In the trial, three different doses of neltependocel plus Y-27632 will be assessed.
It enrolled a total of 97 subjects across study sites in the US and Canada.
The primary endpoint of the trial is to determine the percentage of subjects who achieve three lines of vision at six months.
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By GlobalDataCharles River Laboratories, a CDMO partner of Aurion Biotech, supplied the drug product for the CLARA trial from its manufacturing facility in Memphis, Tennessee.
A serious condition, corneal oedema secondary to endothelial dysfunction impairs vision and affects millions globally.
Aurion Biotech president and chief medical officer Michael Goldstein said: “Aurion Biotech is delighted that both enrolment and dosing in our Phase I/II trial are now complete, and that it happened more rapidly than we expected.
“We enrolled and dosed subjects in six months, which speaks to the deep interest among physicians and patients for our allogeneic cell therapy, as well as the potentially large, unmet need for our elegant, minimally invasive procedure to treat this sight-threatening disease.”
In March 2024, Aurion Biotech dosed the first Canadian subject in the Phase I/II ABA-1, CLARA trial of AURN001.
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