UNITY Biotechnology Announces Topline Results from the ASPIRE Phase 2b Study in Diabetic Macular Edema

Core Insights - UBX1325 demonstrated vision gains comparable to aflibercept in patients with diabetic macular edema (DME) at weeks 24 and 36, achieving non-inferiority at a >90% confidence interval [1][3] - The treatment resulted in a +5.2 letter gain in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks [1][3] - UBX1325 was numerically superior to aflibercept at 7 out of 10 time points in patients with moderately aggressive disease [1][2] Company Overview - UNITY Biotechnology, Inc. is focused on developing therapeutics to slow, halt, or reverse diseases of aging, with a current emphasis on retinal diseases [9] - UBX1325 is a novel BCL-xL inhibitor designed to eliminate senescent cells in diabetic retinal blood vessels while preserving healthy cells [4][8] - The company aims to transform real-world outcomes for patients with retinal disease through its investigational compound [8] Clinical Trial Details - The Phase 2b ASPIRE study involved 52 subjects randomized to receive either UBX1325 or aflibercept, with the primary endpoint being non-inferiority in visual acuity [6] - The study showed that UBX1325-treated patients had a mean change in Best-Corrected Visual Acuity (BCVA) of +5.2 ETDRS letters at 24 weeks and +5.5 ETDRS letters at 36 weeks, with a slight numerical advantage over aflibercept [3][6] - The ASPIRE study is designed to evaluate the safety and efficacy of UBX1325 in patients with active DME who are not achieving optimal benefit from standard anti-VEGF treatments [6] Market Context - Approximately 1.7 million people in the U.S. have DME, with around 750,000 diagnosed and treated [2] - The standard of care for DME has been anti-VEGF agents for the past 20 years, but many patients experience sub-optimal responses [2] - UBX1325 could provide a new treatment alternative for patients who do not achieve optimal results from existing therapies [4]