Unity Biotechnology Unveils Mixed Data From Study For Diabetes-Related Blindness, Stock Falls
The Phase 2b ASPIRE clinical trial of intravitreal UBX1325 involed patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment.
The study results include data from all patients through 24 weeks and most patients through 36 weeks.
UBX1325 treatment led to visual acuity gains of over 5 letters from baseline at weeks 24 and 36 and achieved non-inferiority to Regeneraon Pharmaceuticals Inc’s Eylea (aflibercept) at 9 out of 10-time points through 36 weeks.
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- UBX1325-treated patients had a mean change in BCVA of +5.2 ETDRS letters from baseline to 24 weeks, representing a difference of +0.4 ETDRS letters compared to the aflibercept arm.
- UBX1325-treated patients had a mean change in BCVA of +5.5 ETDRS letters from baseline to 36 weeks, representing a difference of +0.2 ETDRS letters compared to the aflibercept arm.
- UBX1325 was non-inferior to aflibercept at all time points through 36 weeks, except for the average of weeks 20 and 24
- 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.
- UBX1325 generally outperformed aflibercept in patients who had moderate disease severity (baseline CST < 400 microns, representing ~60% of study patients) (pre-specified analysis)
- Patients who switched from aflibercept as their anti-VEGF treatment before study enrollment to UBX1325 had the most consistent and durable vision gains (pre-specified analysis)
UBX1325 continues to demonstrate a favorable safety and tolerability profile.
Unity anticipates the complete 36-week data results of the remaining patients in the second quarter of 2025.
As of
Price Action: UBX stock is down 34.8% at
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