NEJM Evidence publishes results from Phase 2 BEHOLD study of UBX1325

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The peer-reviewed journal NEJM Evidence has published results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). The article titled, “Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema,” notes that the selective clearance of senescent cells in the retina provided disease-modifying and long-lasting improvements in vision in patients with DME. This finding supports the potential of UBX1325 as a novel modality for retinal diseases. This therapeutic candidate is currently be developed by United Biotechnology, Inc.

Anirvan Ghosh, PhD, chief executive officer of UNITY and an author of the paper that was published is quoted in the company’s press release¹ on the subject, saying, “By targeting senescent cells, we expect to remodel the retinal vasculature, which should lead to improvements in retinal function. We see the impact of this approach in action in the BEHOLD study, in which patients experienced meaningful and sustained improvements in their visual acuity for 1 year after a single injection of UBX1325. By selectively targeting an underlying cause of inflammation and disease progression, senolytic therapies could provide a valuable future treatment option for DME patients.”

At the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, the company shared that a single injection of the senolytic candidate UBX1325 led to a statistically significant and clinically meaningful improvement in vision with extended durability through 48 weeks in patients with advanced DME. ¹

UNITY is currently conducting a Phase 2b ASPIRE study to evaluate multiple doses of UBX1325 in a head-to-head comparison to aflibercept. Topline 24-week and 36-week data was disclosed on March 24, 2025. ASPIRE (NCT06011798) is a multi-center, randomized, double-masked, active-controlled Phase 2b study. The study enrolled 52 subjects who were randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every 8 weeks for 6 months after randomization.²

Results from the trial show that UBX1325-treated patients had a mean change in best corrected visual acuity (BCVA) of +5.2 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline to 24 weeks and +5.5 ETDRS letters from baseline to 36 weeks. Furthermore, UBX1325 was shown to be non-inferior to aflibercept at all time points through 36 weeks, except for the average of weeks 20 and 24.

It was also noted that patients on UBX1325 had an increase in Central Subfield Thickness (CST) at weeks 16 and 20, which resulted in supplemental anti-VEGF treatments in patients with significant CST gain.²

Full, 36-week data from the Phase 2b ASPIRE study is expected in the second quarter of 2025.¹

Reference:

1. UNITY Biotechnology Announces Publication in NEJM Evidence Highlighting the Potential of Senolytic Therapeutics to Provide Long-Term Improvements in Vision in DME. Unity Biotechnology, Inc. April 23, 2025. Accessed April 24, 2025. https://www.globenewswire.com/news-release/2025/04/23/3066308/0/en/UNITY-Biotechnology-Announces-Publication-in-NEJM-Evidence-Highlighting-the-Potential-of-Senolytic-Therapeutics-to-Provide-Long-Term-Improvements-in-Vision-in-DME.html

2. UNITY Biotechnology announces topline results from the ASPIRE phase 2b study in Diabetic Macular Edema. Globe Newswire. Published March 24, 2025. Accessed March 24, 2025. https://www.globenewswire.com/news-release/2025/03/24/3047713/0/en/UNITY-Biotechnology-Announces-Topline-Results-from-the-ASPIRE-Phase-2b-Study-in-Diabetic-Macular-Edema.html