UNITY Biotechnology’s Phase 2b ASPIRE trial evaluates UBX1325, a novel senolytic targeting senescent retinal cells to treat diabetic macular edema. Against aflibercept, UBX1325 demonstrates non-inferior vision gains overall and superior outcomes in a moderately aggressive patient subgroup, guiding future pivotal studies.
Key points
- UBX1325 is a small-molecule senolytic targeting anti-apoptotic pathways in senescent retinal cells
- Phase 2b ASPIRE trial compared UBX1325 monotherapy against standard aflibercept in DME patients
- Primary endpoint was non-inferiority in BCVA averaged between weeks 20 and 24
- Subgroup with moderately aggressive DME showed superior BCVA improvements with UBX1325
- Future plans include 36-week data release and proteomic analyses of aqueous humor markers
Why it matters: This trial provides the first replicated clinical evidence that senolytic therapy can improve outcomes in age-related retinal disease. It validates senescent cell clearance as a viable mechanism, potentially opening new therapeutic avenues for DME and broader age-associated pathologies beyond existing anti-VEGF treatments.
Q&A
- How do senolytics eliminate senescent cells?
- What is BCVA and why was it used?
- Why didn't the trial meet the primary endpoint?
- What is the significance of the subgroup analysis?
