Topline results from phase 2b clinical trial of UBX1325 for DME expected in Q1 2025

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UNITY believes that its lead candidate, UBX1325 (foselutoclax), with its unique mechanism of action, has the potential to improve long-term visual outcomes in DME patients by addressing treatment burdens and suboptimal responses seen with standard therapies.¹

A phase 2b trial, dubbed ASPIRE, evaluating the safety and efficacy of UBX1325 compared to aflibercept is underway. Topline results from the 24-week primary endpoint data are expected in the first quarter of 2025, with 36-week data following in the second quarter of 2025. The study's endpoint for regulatory approval will assess best-corrected visual acuity (BCVA) using the ETDRS scale, a tool for assessing visual acuity measurements.Data from the ASPIRE study is expected to provide essential insights to inform the design of potential pivotal trials. ¹

UNITY had a Type C interaction with the U.S. Food and Drug Administration (FDA) regarding the development of UBX1325. Based on this feedback, the company anticipates that a pivotal study would need to be a non-inferiority trial comparing UBX1325 to aflibercept.¹

Reference:

1. UNITY Biotechnology Prepares For Key Data Readouts In 2025 For UBX1325 In Diabetic Macular Edema. UNITY Biotechnology, Inc. January 6, 2025. Accessed January 10, 2025. https://www.rttnews.com/3500679/unity-biotechnology-prepares-for-key-data-readouts-in-2025-for-ubx1325-in-diabetic-macular-edema.aspx?refresh=1