36-week results from the Phase 2b ASPIRE for DME

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UNITY Biotechnology shared complete 36-week results from the Phase 2b ASPIRE (NCT06011798) clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME). In previous reporting, the company shared 24-week and interim 36-week results from the ASPIRE trial. These multiple datasets demonstrated that UBX1325 was non-inferior to aflibercept at most time points through 36 weeks, except for the average of weeks 20 and 24, the primary endpoint.¹

The company is set to present this complete 36-week data from the ASPIRE study at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting on Wednesday, May 7, 2025.¹

The complete 36-week results of the Phase 2b ASPIRE study saw non-inferior visual gains in Best-Corrected Visual Acuity (BCVA) compared to leading anti-VEGF product. UBX1325 was statistically non-inferior to aflibercept at week 36 and generally outperformed aflibercept in subjects who had moderately aggressive disease (central subfield thickness (CST) <400 microns at baseline or at first run-in).¹

As for the safety and tolerability profile of UBX1325, the candidate continues to demonstrate a favorable safety and tolerability profile. There have been no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis, or vasculitis across multiple studies.¹

In the company’s press release¹, Anirvan Ghosh, PhD, chief executive officer of UNITY, commented on this milestone and the pharmaceutical candidates potential, saying, “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.”

The ASPIRE Study

ASPIRE is a multi-center, randomized, double-masked, active-controlled Phase 2b 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 enrolled 52 subjects who were randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every 8 weeks for 6 months after randomization. The primary efficacy endpoint is non-inferiority to aflibercept as assessed by mean change from baseline in BCVA to the average of weeks 20 and 24.¹

About UBX1325

UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not yet approved for any use in any country. UBX1325 is a potent small molecule inhibitor of BCL-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival.¹

Reference:

1. UNITY Biotechnology Announces Complete 36-Week Results from the ASPIRE Phase 2b Study of UBX1325 in Diabetic Macular Edema and Provides Corporate Updates. Unity Biotechnology. May 5, 2025. Accessed May 6, 2025. https://www.biospace.com/press-releases/unity-biotechnology-announces-complete-36-week-results-from-the-aspire-phase-2b-study-of-ubx1325-in-diabetic-macular-edema-and-provides-corporate-updates