Unity Biotechnology is advancing UBX1325 (foselutoclax), a novel senolytic therapy, as a potential treatment for diabetic macular edema (DME). The company anticipates topline results from the Phase 2b ASPIRE trial in the first quarter of 2025, with further data expected in the second quarter. This study evaluates UBX1325's safety and efficacy against aflibercept, a current standard of care, aiming to address the limitations of existing treatments for DME.
ASPIRE Trial Design and Endpoints
The Phase 2b ASPIRE trial is comparing UBX1325 to aflibercept (Eylea) in patients with DME. The primary endpoint at 24 weeks will assess best-corrected visual acuity (BCVA) using the ETDRS scale, a key measure for visual function. Subsequent data at 36 weeks will also be analyzed. Unity Biotechnology expects that the ASPIRE study's results will provide crucial insights for designing potential pivotal trials.
Regulatory Pathway
Following a Type C interaction with the U.S. Food and Drug Administration (FDA), Unity Biotechnology anticipates that a pivotal study for UBX1325 would need to demonstrate non-inferiority compared to aflibercept. This feedback shapes the company's strategy for future clinical trials and regulatory submissions.
UBX1325: Targeting Senescent Cells in DME
UBX1325 is designed to selectively eliminate senescent cells, which contribute to aging and various diseases. In the context of DME, Unity believes UBX1325's unique mechanism could improve long-term visual outcomes by addressing treatment burdens and suboptimal responses associated with standard therapies like anti-VEGF injections.
Financial Position
Unity Biotechnology reported a net loss of $6.5 million for the third quarter of 2024, compared to a $14.8 million loss in the same period last year. The company's research and development expenses decreased to $2.8 million, reflecting the completion of earlier clinical studies. As of the end of the quarter, Unity had $29.0 million in cash, cash equivalents, and marketable securities, expected to fund operations into the third quarter of 2025.
Prior Clinical Data
UBX1325 has previously demonstrated positive results in the Phase 2 ENVISION study for age-related eye diseases, including wet AMD. The study showed that UBX1325 maintained vision gains and significantly reduced the need for anti-VEGF treatments in patients with wet AMD. Specifically, 40% of UBX1325-treated patients did not require anti-VEGF rescue through 48 weeks.
