Unity Biotechnology announces design of Phase 2b ASPIRE trial

UNITY Biotechnology announced the design of its Phase 2b ASPIRE clinical trial, which will evaluate UBX1325 head-to-head against aflibercept in previously treated patients with active diabetic macular edema, DME, who are not achieving optimal benefit from standard of care. UNITY expects to begin activating clinical trial sites in the third quarter and dose the first patient in the fourth quarter of 2023. ASPIRE Trial Design: The Phase 2b ASPIRE study is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept. Patients will be randomized 1:1 to receive either 10 undefined UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months. The study will enroll participants with non-proliferative diabetic retinopathy who have residual visual acuity deficits and excess fluid in the retina despite having received at least three anti-VEGF injections in the preceding six months. All participants will receive three doses of 2 mg aflibercept as a “run-in” prior to randomization. The study will enroll approximately 40 participants, with 20 participants per arm, who have plateaued in their anti-VEGF response and are no longer receiving optimal benefit from standard of care treatment. The primary efficacy endpoint will be mean change from baseline in Best Corrected Visual Acuity to week 24. Secondary endpoints will include change in BCVA over time, and CST change from baseline to week 24. UNITY will begin activating clinical trial sites in the ASPIRE study in Q3 2023 and expects the first patient to be dosed in Q4 2023. With current timelines, last patient visit is expected to be in Q4 2024, with 16- and 24-week data readouts anticipated in Q1 2025.