ASPIRE Phase 2b
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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Clinical Development Strategy
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.
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Mechanism
Indication
Lead Optimization
IND-Enabling
Phase 1
Phase 2
Phase 3
Ophthalmology
BCL-xL Inhibition
Diabetic Macular Edema
Diabetic Macular Edema
Tie2/αVEGF bi-specific
Retinal Vascular Diseases
Tie2 Agonistic Antibody
Retinal Vascular Diseases
Neurology
α-Klotho
Cognitive Disorders
Lead Product Candidate – UBX1325
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).
We believe UBX1325 can transform how retinal diseases are treated. With a novel senolytic mechanism of action, UBX1325 has the potential to be a longer-lasting, disease-modifying therapy for patients.
Clinical Development of UBX1325
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.
The ASPIRE Study Design
A Phase 2b study (ASPIRE) is currently evaluating UBX1325 head-to-head against aflibercept in patients with DME.
Tie2 and Tie2/aVEGF Bispecific Candidates for Retinal Diseases
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.
Clinical Trials
UNITY is currently conducting the following clinical studies:
For patients or physicians interested in learning more about the studies, please visit clinicaltrials.gov.