UNITY Biotechnology announces positive data from Phase 1 clinical trial of UBX1325 in patients with age-related macular degeneration (AMD) and diabetic macular oedema (DME) and advances UBX1325 to Phase 2a.
UNITY Biotechnology, a biotech company developing therapeutics to slow, halt or reverse diseases of aging, has announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from DME or wet AMD for whom anti–vascular endothelial growth factor therapy (anti-VEGF therapy) was no longer considered beneficial.
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UBX1325, a small molecule inhibitor of Bcl-xL and the first senolytic therapeutic evaluated in an ophthalmological clinical study, was, the study found, well-tolerated with no treatment-related adverse events or dose-limiting toxicities. Additionally, the majority of DME and wet AMD patients treated with a single injection of UBX1325 demonstrated rapid improvements in best-corrected visual acuity (BCVA), central subfield thickness (CST), and sub- and intra-retinal fluid (SRF, IRF), 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. In addition, UNITY is enrolling additional patients with advanced wet AMD in the Phase 1 study to gather additional data to support a Phase 2a study in wet AMD. These studies are expected to generate data to inform the efficacy of UBX1325 in a wider range of patient populations, including those who are refractory to anti-VEGF treatment.
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“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,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “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. We look forward to several important data readouts in the coming year that will further inform the optimal treatment regimen for UBX1325 in patients with DME and wet AMD.”
“The imaging data demonstrating structural improvements in the retina are compelling at this stage of clinical development and represent defined endpoints for disease improvement,” said Dr Jeffrey Heier, Director of the Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston. “Importantly, UBX1325 is an entirely new treatment modality for eye disease and is particularly exciting for this patient population for whom new therapeutic options could provide significant additional benefits alone or in combination with anti-VEGF agents.”
The Phase 1, first-in-human, open-label, single-ascending dose study included 12 patients with advanced DME or wet AMD who were no longer expected to benefit from anti-VEGF therapies. UBX1325 was well tolerated in this patient population and demonstrated a favourable acute safety profile supporting further clinical development. There were no dose-limiting toxicities observed, with two non-serious, non-drug-related adverse events reported. In addition, patients treated with UBX1325 had improvements in vision and retinal structure, including gains in ETDRS letters from baseline in best-corrected visual acuity (BCVA), decreases in central subfield thickness (CST), reductions in subretinal / intraretinal fluid and improvement in disease-relevant pathology.
Dr Jamie Dananberg, chief medical officer of UNITY, added: “The patients enrolled in this study had advanced disease for whom anti-VEGF therapies, the standard of care for DME and wet AMD, were no longer thought to be of benefit. Seeing treatment-related improvement in these difficult-to-treat patients is very promising and supports the investigation of UBX1325’s potential as a differentiated, disease-modifying treatment option for a broad patient population. We look forward to further exploring the efficacy of this novel mechanism to alter the course of disease progression in DME patients in the recently initiated Phase 2a study.”
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