UNITY Biotechnology Inc. (NASDAQ: UBX) has announced the design for the second phase study of UBX1325 in wet age-related macular degeneration and anticipated milestones for 2022.
UBX1325 is a new retinal medicine for AMD
CEO of UNITY Anirvana Ghosh said, “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. 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. 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.”
In the first half of 2022, UNITY plans to release 12-week efficacy and safety data from its current Ph2 study of UBX1325 in DME, as well as preliminary results from the Ph2 trial in wet AMD in the 2H 2022.
Study to commence on 1H 2022
The protocol for UBX1325’s second Phase proof of concept research in wet AMD has been filed to the US Food and Drug Administration, and the study will begin in the first half of 2022. Patients will be given two BX1325 10 mcg doses at weeks 0 and 4 or two doses of aflibercept 2 mg after eight weeks. As defined by a change in BCVA from baseline, visual acuity improvement is the primary outcome.
Chief Medical Officer of UNITY, Jamie Dananberg, said, “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. 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.”
