Unity Biotechnology releases topline results from phase 2b ASPIRE trial of UBX1325 in patients with diabetic macular edema

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Unity Biotechnology announced topline results from its phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment.

Results from the trial include data from all patients through 24 weeks and the majority of patients through 36 weeks.

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.

UBX1325 is a novel BCL-xL inhibitor designed to eliminate senescent cells in diabetic retinal blood vessels while leaving healthy ones intact, administered via intravitreal injections.

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.

Unity Biotechnology also shared that those patients who switched from aflibercept as their anti-VEGF treatment prior to study enrollment to UBX1325 had the most consistent and durable vision gains.

David S. Boyer, MD, partner at Retina Vitreous Associates Medical Group and adjunct clinical professor of ophthalmology at Keck School of Medicine of USC, commented on the trial results in a press release from Unity Biotechnology.

“Achieving durable improvements in visual acuity via an entirely new mechanism of action as seen in this study is remarkable and would be invaluable for patients receiving sub-optimal response from current treatment options,” said Boyer. “Currently, about half of all patients don’t get optimal results from standard of care treatment and end up cycling through various anti-VEGF-based treatments which do not provide additional vision benefit. UBX1325, if approved, could help patients break out of this burdensome cycle and would be a welcome treatment alternative for patients.”

The company anticipates that the complete 36-week data results of the remaining patients will be available in the second quarter of 2025.

References:

1. 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