Unity Biotechnology Unveils Mixed Data From Study For Diabetes-Related Blindness, Stock Falls

Unity Biotechnology, Inc. UBX stock plummeted on Monday after the company released results from its latest study.

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 REGN 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 December 31, 2024, cash, cash equivalents, and marketable securities totaled $23.2 million, sufficient to fund operations into the fourth quarter of 2025.

Price Action: UBX stock is down 34.8% at $1.19 at the last check Monday.

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