Unity Biotechnology's Phase 2b Study Misses Primary Analysis Endpoint, Stock Falls In Pre-Market

(RTTNews) - Unity Biotechnology, Inc. (UBX), Monday announced the topline results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema or DME.

The study, which enrolled 52 subjects, evaluated the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active DME who are not achieving optimal benefit from standard of care.

The findings revealed that UBX1325 was non-inferior to aflibercept at week 24. However, it did not meet statistical non-inferiority on the average of weeks 20 and 24, the primary analysis endpoint, where it achieved 88 percent confidence interval compared to pre-specified 90 percent threshold.

The study also found that UBX1325-treated patients had a +5.2 letter gain in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks. Moreover, UBX1325 was numerically superior to aflibercept at 7 out of 10 time points in a pre-specified population with moderately aggressive disease

The company's CEO Anirvan Ghosh stated that they are planning to advance UBX1325 to late-stage studies against aflibercept in DME patients with inadequate response to anti-VEGF therapies.

The biotechnology company expects the complete 36-week data results of the remaining patients in the second quarter of 2025.

In the pre-market hours, Unity's stock is trading at $1.18, down 35.34 percent on the Nasdaq.