UNITY Biotechnology (NASDAQ:UBX) announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from diabetic macular edema (DME) or wet age-related macular degeneration (AMD) for whom anti-VEGF therapy was no longer considered beneficial.
UBX1325 is the first senolytic therapeutic evaluated in an ophthalmological clinical study. It was well-tolerated with no treatment-related adverse events or dose-limiting toxicities.
In addition, the majority of DME and wet AMD patients treated with a single injection of UBX1325 demonstrated rapid improvements in best-corrected visual acuity, central subfield thickness and sub- and intra-retinal fluid, all key clinical measures of disease progression.
The first patient has been dosed in a Phase 2a clinical study to assess the safety and efficacy of UBX1325 in a broader population of patients with DME, and data is expected in the first half of 2022.
“We are very excited by the initial efficacy we see with UBX1325, including improvements in vision and structure in advanced patients, which suggest that UBX1325 may benefit a wide range of patients suffering from DME or wet AMD,” Anirvan Ghosh, Ph.D., CEO of UNITY, said in a statement.
“UBX1325 targets an entirely novel mechanism to eliminate senescent cells in the retinal and choroidal vasculature, a potential root cause of disease progression, and could provide a valuable alternative or adjunctive treatment option to anti-VEGF therapies,” he added.