UBX1325 fails to meet primary analysis endpoint despite vision gains in DME
Key takeaways:
- UBX1325 did not meet statistical noninferiority to aflibercept on the average of weeks 20 and 24.
- Patients treated with UBX1325 had vision gains comparable to aflibercept at weeks 24 and 36.
Editor’s note: This is a developing news story. Please check back soon for updates.
Intravitreal UBX1325 helped patients with diabetic macular edema gain vision but failed to meet its primary analysis endpoint in the ASPIRE clinical trial, according to a press release from Unity Biotechnology.
https://ir.unitybiotechnology.com/news-releases/news-release-details/unity-biotechnology-announces-topline-results-aspire-phase-2b. Published March 24, 2025. Accessed March 24, 2025.
The phase 2b study evaluated the safety and efficacy of UBX1325 compared with aflibercept in patients with DME who previously underwent treatment but did not achieve optimal benefit. Fifty-two patients were randomly assigned 1:1 to receive either 10 µg UBX1325 or 2 mg aflibercept control injections every 8 weeks for 6 months. The primary efficacy endpoint was noninferiority to aflibercept assessed by mean change in best corrected visual acuity from baseline to the average of weeks 20 and 24, according to the release.
Patients who received UBX1325 achieved vision gains comparable to aflibercept at weeks 24 and 36. Patients in the UBX1325 group had a mean gain of 5.2 letters at week 24 and 5.5 letters at week 36, according to the release.
Although UBX1325 was noninferior to aflibercept at week 24, it did not meet statistical noninferiority on the average of weeks 20 and 24; it achieved noninferiority at an 88% confidence interval compared with a 90% threshold that was set as the primary analysis endpoint.
The topline data included all patients through 24 weeks and the majority of patients through 36 weeks. Unity expects to have complete results through 36 weeks for all patients in the second quarter, according to the release.
“We are excited that UBX1325 showed robust vision improvements in a difficult-to-treat patient population,” Anirvan Ghosh, PhD, CEO of Unity, said in the release. “The results also suggest that UBX1325 may provide greater vision gains than standard of care in patients with moderately aggressive disease. We look forward to advancing UBX1325 to late-stage studies against aflibercept in DME patients with inadequate response to anti-VEGF therapies.”
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