UNITY Biotechnology (NASDAQ:UBX) announced positive 24-week data from its Phase 1 single ascending dose safety study of UBX1325 in patients with advanced disease from diabetic macular edema (DME) or wet age-related macular degeneration (AMD).
A majority of patients with DME across all doses had rapid improvements in vision, and patients in the higher dose cohorts showed a mean gain of 9.5 early treatment diabetic retinopathy study letters in best-corrected visual acuity at 24 weeks following a single injection of UBX1325.
In addition, a majority of wet AMD patients treated with UBX1325 showed rapid gains in visual acuity, which were maintained through 12 weeks. In most patients, central subfield thickness remained stable through the study period.
The study enrolled a total of 19 patients with advanced DME and wet AMD for whom anti-VEGF therapy was no longer considered beneficial. UBX1325 was well-tolerated at all doses tested, through 10 mcg, with no dose-limiting toxicities and no reported incidence of inflammation.
“A 10 letter gain in DME patients, maintained through six months, is an impressive outcome, and is particularly noteworthy considering that it was achieved with a single injection,” Arshad Khanani, M.D., managing partner of Sierra Eye Associates, said in a statement.
“A treatment that reduces the frequency of injections while showing meaningful and sustained improvements in best-corrected visual acuity would be of huge value for patients and physicians,” he added.
Robert Bhisitkul, M.D., professor of ophthalmology and director of the Retina Fellowship at University of California, San Francisco, said patients with wet AMD will lose vision without treatment and have a worse prognosis than patients with DME, which is “why the letter gain seen in the AMD cohort is so meaningful.”
Anirvan Ghosh, Ph.D., UNITY’s CEO, said the improvements in vision and retinal structure suggest that this new mechanism of action – the selective elimination of senescent cells in diseased retinal tissue – has the “potential for disease-modifying effect in a large proportion of patients struggling to manage their disease.”
UNITY’s Phase 2 study of UBX1325 in DME is underway, with 12-week safety and efficacy data anticipated in the first half of 2022. A Phase 2 study in wet AMD is planned for the first half of 2022, with 12-week data expected in the second half of the year.