Unity Biotechnology, Inc. announced that the ongoing Phase 2b ASPIRE study of UBX1325 has been extended from 24 to 36 weeks to assess potentially greater durability compared to aflibercept. In addition, the study is being upsized from 40 to 50 patients to increase the statistical power. 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).

As a result of extending the study, UNITY expects to disclose topline results from the ASPIRE study in two data readouts: 24-week primary endpoint data in the first quarter of 2025, and 36-week long-term extension data in the second quarter of 2025. The Company continues to believe that current cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2025. 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.

UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not 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.

The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY?s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease.