Active: ASPIRE Phase 2b study evaluating the safety and efficacy of multiple doses of UBX1325 in patients with diabetic macular edema (NCT06011798)
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We are developing therapeutics that target senescence and adjacent biology with established endpoints and well-defined regulatory pathways to approval. Our initial focus is on delivering localized therapy in ophthalmologic diseases.
UNITY is developing the first senolytic therapy for the treatment of retinal diseases. UBX1325 is a potent small molecule that targets BCL-xL, a protein that senescent cells rely on for survival. By eliminating senescent cells in the retina, UBX1325 potentially removes a significant source of pathogenesis, allows healthy cells to regenerate to restore vasculature to a more functional state, reestablishes barrier function in the eye, and ultimately leads to long-term disease modification and vision improvement in patients with diabetic macular edema (DME) or age-related macular degeneration (AMD).
In the Phase 2 BEHOLD study, UBX1325 achieved sustained improvements in visual acuity and stabilization of retinal structure for nearly one year after a single injection in patients with DME.
A Phase 2b study (ASPIRE) is currently evaluating UBX1325 head-to-head against aflibercept in patients with DME.
The Tie2/angiopoietin signaling axis is critical to the maintenance of normal vascular homeostasis in ocular tissues and becomes dysregulated in age-related eye diseases. The imbalanced overexpression of angiopoietin-2 leads to Tie2 inhibition, a loss of vascular integrity, and pathological neovascularization. We believe that therapeutic re-activation of Tie2 signaling will restore ocular vasculature to a healthier state and improve vision in patients with DME or AMD.
UBX2050 is an investigational fully human Tie2-activating monoclonal antibody that has been shown to restore Tie2 function independently of angiopoietin-2 binding. UBB2048 is an investigational fully human Tie2-activating and VEGF neutralizing bi-specific antibody. Both inhibit pathological neovascularization, and restore healthy vasculature in preclinical disease models.
UNITY is currently conducting the following clinical studies:
For patients or physicians interested in learning more about the studies, please visit clinicaltrials.gov.