UNITY Biotechnology Reports 36-Week Results from Phase 2b ASPIRE Trial of UBX1325 in DME

UNITY Biotechnology has announced the complete 36-week results from its Phase 2b ASPIRE clinical trial (NCT06011798) evaluating intravitreal UBX1325 in patients with diabetic macular edema (DME). These results are based upon previously shared 24-week and interim 36-week data, which collectively show that UBX1325 was non-inferior to aflibercept at most time points through 36 weeks, except for the primary endpoint—the average of weeks 20 and 24.

The full dataset will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting on Wednesday, May 7, 2025.

Efficacy Results Support Novel Therapeutic Potential

At week 36, UBX1325 demonstrated non-inferior gains in Best-Corrected Visual Acuity (BCVA) when compared to aflibercept. Notably, the investigational therapy outperformed aflibercept in patients with moderately aggressive disease, characterized by central subfield thickness (CST) <400 microns at baseline or at first run-in.

These results reinforce the therapeutic promise of UBX1325 as a viable alternative to anti-VEGF therapies, particularly in patients who show suboptimal responses to current standard of care.

Strong Safety and Tolerability Profile Maintained

UBX1325 continues to show a favorable safety and tolerability profile across multiple clinical studies. No cases of intraocular inflammation, retinal artery occlusion, endophthalmitis, or vasculitis have been reported to date.

Executive Commentary on UBX1325 and ASPIRE Trial Findings

In the company’s announcement, Anirvan Ghosh, PhD, CEO of UNITY Biotechnology, highlighted the drug candidate’s novel mechanism and potential positioning in the treatment landscape:

“UBX1325 has demonstrated the potential to provide a much-needed alternative treatment to anti-VEGF therapy through a completely novel mechanism of action. “UBX1325’s demonstration of non-inferiority to aflibercept at 36 weeks and superior vision gains in the subgroup of patients with CST under 400 microns underscores its potential to provide a valuable treatment option to patients.

We believe that further development of UBX1325 would benefit from the capabilities of a company with an existing ophthalmic franchise, and we are exploring partnerships so that this program can continue to be advanced as a potential new treatment. I am proud of the valuable contributions our team has made in advancing a new therapeutic concept for DME, as featured in our recently published article in NEJM Evidence.”

ASPIRE Study Design

The ASPIRE trial is a multi-center, randomized, double-masked, active-controlled Phase 2b study. It was designed to evaluate the safety and efficacy of UBX1325 versus aflibercept in previously treated patients with active DME who are not achieving optimal benefit from current therapies.

       • Total participants: 52

       • Randomization: 1:1

       • Treatment arms:

               • 10 μg UBX1325

               • 2 mg aflibercept every 8 weeks for 6 months

       • Primary efficacy endpoint: Non-inferiority in BCVA change from baseline, assessed as the average of weeks 20 and 24

About UBX1325

UBX1325 is an investigational small molecule inhibitor of BCL-xL, a protein in the BCL-2 family that supports the survival of senescent cells. It is being developed for use in retinal diseases, including DME, and is not currently approved for use in any country. By targeting the senescence-associated survival pathways, UBX1325 may offer a novel approach to disease modification in retinal vascular disorders.