Enrollment completed for ENVISION Phase 2 clinical trial investigating UBX1325 for the treatment of AMD

Unity Biotechnology has completed enrollment for the ENVISION study, its Phase 2 clinical trial (NCT05275205) of UBX1325 in patients with wet age-related macular degeneration (AMD).

According to the company, this is an active comparator study, examining the efficacy of two doses of UBX1325 compared to every other month treatment with aflibercept through 24 weeks.

Anirvan Ghosh, PhD, CEO of Unity, noted in the news release that the completion of enrollment of the ENVISION study is an important milestone for the clinical trial and illustrates the momentum and interest in the program as we continue to explore indications where UBX1325 could provide benefit beyond current standard of care.

“UBX1325 is a first in class senolytic agent being studied as a treatment for retinal disease, Ghosh said in a statement. “Following the initial evidence of a treatment effect of UBX1325 in patients with diabetic macular edema (DME), we are excited to assess the safety and efficacy of UBX1325 in patients with wet AMD.”

Moreover, Ghosh noted that the company has had a number of critical data readouts over the next three quarters, and a cash runway that extends into 2024.

“Our next major milestone is the 24-week data from the BEHOLD study in DME, expected by end of year 2022, followed by 48-week results in the second quarter of 2023,” he added in the release. “In the EVISION study we expect 16-week data in the first quarter of 2023, with 24-week data to follow in the second quarter of 2023. We look forward to sharing data from these studies in the months to come.”

Phase 2 ENVISION study

According to the company, ENVISION is a multi-center, randomized, active comparator-controlled, double-masked Phase 2 study designed to evaluate the safety, tolerability, efficacy, and durability of UBX1325 in patients with wet AMD. Patients are randomized into one of two study arms – patients receive either A) two doses of UBX1325 (10 mcg) at week 0 and week 4, or B) aflibercept (2 mcg) every eight weeks for a total of four injections. Outcome measures include safety and tolerability, average change in BCVA from baseline at 16 and 24 weeks as well as change in CST from baseline at 16 and 24 weeks.

About UBX1325

UBX1325 is an investigational compound being studied for age-related diseases of the eye, including AMD, diabetic macular edema (DME), and diabetic retinopathy (DR) that 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.

In the Phase 2 BEHOLD study in patients with DME, a single injection of UBX1325 led to a progressive, statistically significant, and clinically meaningful improvement in mean Best Corrected Visual Acuity (BCVA) at 12- and 18-weeks compared to sham treatment. In a Phase 1 clinical study in advanced wet AMD and DME, UBX1325 showed a favorable safety profile and improvements in visual acuity sustained through 24 weeks following a single intravitreal injection. 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 – including improved vision, a longer more durable effect, and lower frequency of treatment – for patients with DME, AMD, and DR.