In addition to direct activation of Tie2, the bispecific candidate is designed to neutralize VEGF-A and VEGF-B. The Tie2-VEGF bispecific has dual functionality on two validated targets for retinal diseases. Preliminary studies suggest that cellular senescence in aging eyes may induce Ang-2 and therefore deactivate Tie2, leading ocular edema. Tie2 is an important key regulator of the vascular endothelium in the eye and dysregulation of this pathway leads to loss of barrier integrity and healthy vasculature. Tie2 is a receptor tyrosine kinase that is implicated in regulating barrier function in blood vessels of the eye, which are affected in several prevalent eye diseases. UNITY continues to investigate new modalities around senescence-related mechanisms and other biology implicated as drivers of diseases of aging: “In wet AMD, the choroidal vasculature is impacted, and we believe that a repeat dose of UBX1325 may result in optimum efficacy and durability for patients.” “The dosing regimen in this Phase 2 study is based on the response kinetics in the Phase 1 study as well feedback from a team of leading clinicians and scientists who advised on the study design,” said Jamie Dananberg, M.D., chief medical officer of UNITY. Patients will have received their last anti-VEGF treatment approximately 4-8 weeks prior to screening, and all patients will be followed for approximately 24 weeks after dosing with either UBX1325 or aflibercept. The study is expected to enroll 46 patients with wet AMD who have had at least three intravitreal injections of anti-VEGF therapy in the preceding six months and who have residual sub- or intra-retinal fluid. The primary endpoint is improvement in visual acuity, as measured by change in BCVA from baseline. Safety and efficacy will be assessed at 8, 16 and 24 weeks. Patients will be randomized to receive either two doses of UBX1325 10 mcg at week 0 and week 4, or aflibercept 2 mg every eight weeks. The study design includes a control arm using standard-of-care aflibercept in patients with neovascular AMD. The Phase 2 clinical trial is a multi-center, randomized, double-masked study designed to evaluate the safety, efficacy and durability of UBX1325. FDA and we anticipate initiating that study in the first half of 2022. The protocol for the Phase 2 proof of concept study of UBX1325 in wet AMD has been submitted to the U.S. UNITY expects to share 12-week safety and efficacy data from its ongoing Ph2 study of UBX1325 in DME in the first half of 2022, and to share initial data from the Ph2 study in wet AMD in the second half of 2022. Looking ahead to 2022, we are working with leading retinal specialists in the field to advance UBX1325 in Phase 2 clinical studies, as well as advancing our senescence-related programs across our pipeline.” “Bcl-xL inhibition – a mechanism for selectively eliminating senescent cells in diseased retinal tissue – has emerged as a promising alternative to anti-VEGF therapy with potentially improved outcomes and dosing regimens that lessen the treatment burden for patients. “2021 was a transformational year for us as our senolytic candidate UBX1325 represents a novel and impressive new class of retinal medicine for the treatment of diabetic macular edema and age-related macular degeneration, as evidenced by Phase 1 results as well as preclinical research published in the journal Cell Metabolism,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. (“UNITY”), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced the design for its Phase 2 study of UBX1325 in wet age-related macular degeneration (AMD) and anticipated milestones for 2022. 04, 2022 (GLOBE NEWSWIRE) - UNITY Biotechnology, Inc. Phase 2 study of UBX1325 in wet AMD to include comparison with afliberceptĪdditional pipeline programs targeting age-related diseases continue to advance 12-week safety and efficacy analysis from a Phase 2 study of UBX1325 in diabetic macular edema (DME) expected in first half 2022 and wet age-related macular degeneration (wet AMD) expected in the second half of 2022
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