Unity Biotechnology extends Phase 2b ASPIRE study of UXB1325 from 24 weeks to 36 weeks
The intent of this extension is to assess potentially greater durability compared to aflibercept and will increase the statistical power of the study.
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UNITY Biotechnology, Inc. shared that the ongoing Phase 2b ASPIRE study of UBX1325 (NCT06011798) has been extended from 24 to 36 weeks. The intent of this extension is to assess potentially greater durability compared to aflibercept. In addition, the study is being upsized from 40 to 50 patients. This will increase the statistical power of the study.1
The ASPIRE study is designed to evaluate the safety, efficacy, and long-term durability of UBX1325 as a monotherapy compared head-to-head to aflibercept in patients with diabetic macular edema (DME).1
In the press release1, Anirvan Ghosh, PhD, chief executive officer of UNITY shared why the data for this mechanism of DME treatment could impact the industry, saying, “We previously demonstrated significant improvement in vision with extended durability in patients treated with UBX1325 in the BEHOLD proof-of-concept study and look forward to extending those findings in the current ASPIRE study. As the only treatment candidate in clinical development for DME that targets senescent cells, UBX1325 leverages a novel mechanism of action that could provide sustained improvements in visual acuity and lessen the treatment burden compared to current standard of care. We see UBX1325 as an emerging, potentially paradigm-shifting therapeutic approach in DME.”
Due to the study extension, UNITY expects to disclose topline results from the ASPIRE study in 2 data readouts. The first is set to be a 24-week primary endpoint data in the first quarter of 2025. The second will be the 36-week long-term extension data in the second quarter of 2025.1
Summary of the ASPIRE study
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 DME who are not achieving optimal benefit from standard of care. The study is expected to enroll about 50 subjects who will be randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months after randomization. There will be no scheduled treatments in either arm between 24 and 36 weeks to allow direct comparison of durability of effect between the two treatment arms. The primary efficacy endpoint is non-inferiority to aflibercept as assessed by mean change from baseline in Best Corrected Visual Acuity (BCVA) to week 24. Secondary endpoints include change in BCVA from baseline over time, Central Subfield Thickness (CST) change from baseline over time, and proportion of participants who do not require anti-VEGF rescue, all through week 36. Additional information about ASPIRE (NCT06011798) can be found here.1
