UNITY Biotechnology Releases Full 36-Week Results of UBX1325 Phase 2b Study in Diabetic Macular Edema and Corporate Updates

UNITY Biotechnology, Inc., a company focused on developing treatments for age-related diseases, recently unveiled the complete 36-week results from their Phase 2b ASPIRE clinical trial. This study assessed the efficacy and safety of UBX1325, an investigational treatment for diabetic macular edema (DME), a condition that results in vision impairment despite prior anti-VEGF therapy. The trial results indicate that UBX1325 demonstrated vision improvements comparable to the leading anti-VEGF treatment, aflibercept, by the 36-week mark.

The ASPIRE trial enrolled 52 participants with DME who did not achieve optimal benefits from standard care. These subjects were randomly assigned to receive either 10 μg of UBX1325 or 2 mg of aflibercept every eight weeks for six months. The main goal was to demonstrate non-inferiority to aflibercept in terms of improvement in Best-Corrected Visual Acuity (BCVA) between weeks 20 and 24. UBX1325 showed statistically non-inferior visual gains compared to aflibercept at 36 weeks, except for the primary endpoint average during weeks 20 and 24.

UNITY's CEO, Dr. Anirvan Ghosh, highlighted that UBX1325 has shown promise as an alternative treatment to anti-VEGF therapy through a novel mechanism of action. The treatment's ability to achieve non-inferior results to aflibercept and superior outcomes in a subgroup of patients with a central subfield thickness (CST) under 400 microns showcases its potential. Ghosh emphasized the need for partnerships with companies having established ophthalmic capabilities to further develop UBX1325 as a new treatment option.

The safety profile of UBX1325 was favorable, with no reported cases of intraocular inflammation, retinal artery occlusion, endophthalmitis, or vasculitis recorded across various studies. This reinforces UBX1325's potential as a safer alternative for patients with DME.

UNITY plans to present the complete results from the ASPIRE study at the ARVO 2025 Annual Meeting. Alongside these findings, UNITY announced a revised operational strategy approved by its Board of Directors. The plan involves exploring strategic alternatives to advance UBX1325 while reducing operational expenses. This includes potential actions such as the sale, licensing, or divestiture of the company's assets and technologies, partnerships, mergers, or other strategic transactions.

As part of this operational shift, UNITY will undergo a workforce reduction, retaining some consulting agreements to conclude the ASPIRE study. The company's top executives will transition to consulting roles to assist in evaluating strategic alternatives and ensure a smooth management transition. Unity might engage external advisors to assist in exploring these alternatives, though there is no guarantee that any transaction will be finalized.

In addition to UBX1325, UNITY is advancing other promising candidates like UBB 2048, which has shown efficacy in preclinical models of retinal disease, and UBX2050, with potential implications for treating vascular diseases. UNITY's broader aim is to develop therapeutics that modulate senescent cells, thereby offering transformational benefits for aging-related eye and neurological diseases.

Through its robust research and strategic initiatives, UNITY Biotechnology continues to pioneer in developing innovative treatments that address age-related conditions, striving to improve the quality of life for patients worldwide.