UNITY Biotechnology, Inc. announced that the first patients have been dosed in the Phase 2 ASPIRE study of UBX1325 (foselutoclax), a Bcl-xL inhibitor being evaluated head-to-head against standard of care anti-VEGF in patients with diabetic macular edema (DME).ASPIRE is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active diabetic macular edema (DME) who are not achieving optimal benefit from standard of care. It is expected to enroll about 40 subjects who will be randomized 1:1 to receive either 10 mg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months. The primary efficacy endpoint will be mean change from baseline in Best Corrected Visual Acuity (BCVA) to week 24.

Secondary endpoints will include change in BCVA over time, and central subfield thickness (CST) change from baseline to week 24. Initial 16-week data is expected in the fourth quarter of 2024 and 24-week data expected in the first quarter of 2025. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue.

UNITY's goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease.