UNITY Biotechnology Completes Enrollment in BEHOLD, the Phase 2 Study of Senolytic Candidate UBX1325 in Diabetic Macular Edema

• 12-week safety and efficacy data anticipated by mid-year 2022
• 24-week safety and efficacy data anticipated before year-end 2022

UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, has completed enrollment for the BEHOLD study, its Phase 2 clinical trial of UBX1325 in patients with diabetic macular edema (DME).

“Patients with advanced retinovascular diseases, including DME, shoulder a significant burden with current standard-of-care that usually requires regular doctor visits for frequent injections of anti-VEGF treatment, often as frequently as every 8 weeks,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Given the encouraging activity we’ve observed in patients with DME after a single injection of UBX1325 in our Phase 1 study in patients no longer considered responsive to anti-VEGF treatment, we’re optimistic that UBX1325 can potentially provide an entirely novel therapeutic option and lessen the current burden on both patients and physicians as a durable senolytic treatment. We are very pleased to have completed enrollment and see this as a significant milestone in the UBX1325 clinical program. We look forward to building on this momentum and anticipate 12-week results from our Phase 2 DME study, BEHOLD, by mid-year and 24-week results by the end of the year.”

The proof-of-concept Phase 2 study, BEHOLD, is a multi-center, randomized, double-masked, sham-controlled study designed to evaluate the safety, tolerability, efficacy and durability of a single 10 mcg dose of UBX1325 in patients with DME. The study enrolled 65 patients who will be followed for up to approximately 48 weeks. More information about the study is available here (NCT 04857996). In parallel, a separate Phase 2 study of UBX1325 in wet age-related macular degeneration is currently enrolling patients, with 16-week results anticipated by year-end 2022. More information about the study is available here (NCT05275205).

About UBX1325

UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), age-related macular degeneration (AMD), 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 a Phase 1 clinical study in advanced vascular eye disease, UBX1325 has shown a favorable safety profile and improvements in visual acuity sustained through 24 weeks following a single dose. 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 DME, AMD, and DR.

About UNITY

UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases.