UNITY Biotechnology is advancing UBX1325 (foselutoclax), a senolytic therapeutic, for diabetic macular edema (DME). Following a Type C interaction with the FDA, the pivotal study for UBX1325 is expected to be a non-inferiority trial against an approved anti-VEGF agent like aflibercept, with the primary endpoint being best-corrected visual acuity (BCVA) assessed by the ETDRS scale, using a non-inferiority margin of 4 letters.
UBX1325: Targeting Senescent Cells in DME
UBX1325 is designed to address the limitations of current DME treatments, such as high treatment burden and suboptimal response rates. The drug acts via a senolytic mechanism, selectively eliminating senescent cells to potentially improve long-term visual outcomes. Anirvan Ghosh, Ph.D., CEO of UNITY, stated that DME represents a large underserved market due to inadequate responses to anti-VEGF standard of care and continued vision loss despite treatment.
ASPIRE Phase 2b Study Details
The Phase 2b ASPIRE study (NCT06011798) is a multi-center, randomized, double-masked, active-controlled trial comparing UBX1325 head-to-head with aflibercept. Topline 24-week primary endpoint data is expected in the first quarter of 2025, with 36-week data following in the second quarter of 2025. This data will be crucial in informing the design of a potential pivotal study.
Financial Position
As of September 30, 2024, UNITY reported cash, cash equivalents, and marketable securities totaling $29.0 million, which the company believes is sufficient to fund operations into the third quarter of 2025. The net loss for the third quarter of 2024 was $6.5 million, compared to $14.8 million for the same period in 2023. Research and development expenses decreased to $2.8 million for the three months ended September 30, 2024, from $4.6 million for the three months ended September 30, 2023.
