Key Takeaways
- Unity Biotechnology will release 24-week topline data from the Phase 2b ASPIRE study in diabetic macular edema (DME) in Q1 2025.
- The study compares the efficacy and safety of foselutoclax (UBX1325) to aflibercept, enrolling approximately 50 patients.
- Yehia Hashad, MD, has joined Unity’s board as the company prepares for the ASPIRE study results and potential late-stage development of UBX1325.
Study Overview
Unity Biotechnology announced that topline data from the Phase 2b ASPIRE study on diabetic macular edema (DME) is expected to be released in the first quarter of 2025, with additional data anticipated in the second quarter of the same year. The ASPIRE study (NCT06011798) is a multi-center, randomized, double-masked, active-controlled trial designed to assess the safety and effectiveness of foselutoclax (UBX1325), comparing it head-to-head with aflibercept for treating DME.
The primary outcome of the study measures the mean change from baseline in best-corrected visual acuity (BCVA) over 36 weeks using the early treatment diabetic retinopathy study (ETDRS) letter grading system. Secondary outcomes include changes in BCVA at weekly intervals, changes in central subfield thickness, and the proportion of participants gaining a specified number of ETDRS letters from baseline.
Approximately 50 participants will be enrolled and divided equally to receive either UBX1325, administered at 10 μg every eight weeks, or aflibercept, given at 2 mg every eight weeks. Unity’s CEO, Anirvan Ghosh, noted the significant need for effective DME treatments, emphasizing that UBX1325 could provide a crucial option for patients experiencing vision loss despite current therapies. He highlighted that the forthcoming 24-week and 36-week data would shape plans for a pivotal trial and further the program.
In a related development, Unity Biotechnology appointed Yehia Hashad, MD, as a member of its board of directors and its science committee. Dr. Hashad brings extensive expertise from his previous role at Allergan Aesthetics and has overseen the development of over 40 pharmaceutical programs. He expressed enthusiasm for joining Unity at this critical time, aiming to contribute to the advancement of therapeutics for retinal diseases. Ghosh affirmed that Dr. Hashad’s knowledge and experience will be invaluable in guiding UBX1325 towards late-stage development.
Overall, Unity Biotechnology is poised to enhance treatment options for patients with DME, fueled by promising clinical trial data and the strategic appointment of Dr. Hashad.
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