UNITY Biotechnology Doses First Patient in ENVISION, the Phase 2 Study of UBX1325 in Wet Age-Related Macular Degeneration

UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patient has been dosed in the ENVISION study, its Phase 2 clinical trial of UBX1325 in patients with wet age-related macular degeneration (wAMD).

“The clinical and preclinical data generated so far suggests that UBX1325, a senolytic small molecule with disease-modifying potential, could improve retinal function through an entirely novel pathway,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The Phase 2 study enables us to further explore whether UBX1325 may provide improved treatment options for patients with wAMD in parallel with our ongoing Phase 2 study, BEHOLD, in diabetic macular edema. We continue to advance our ophthalmology programs, with a sharpened focus into the next stage of development and remain on track to announce data from both studies over the course of the year.”

The Phase 2 trial in wAMD, ENVISION, is a multi-center, randomized, active comparator controlled, double-masked study designed to evaluate the safety, tolerability, efficacy, and durability of UBX1325 in patients with wAMD. The study is actively recruiting patients and is targeted to enroll 46 patients with wAMD, who will be randomized to receive either two doses of UBX1325 (10 mcg) at week 0 and week 4, or aflibercept (2 mcg) every eight weeks. The Company expects 16-week safety and efficacy results from the ongoing study in the fourth quarter of 2022. More information about the study is available here (NCT05275205).

“Encouraged by the clinical data generated in the Phase 1 study, in which the majority of patients treated with a single dose of UBX1325 showed an increase in visual acuity at 24 weeks, the Phase 2 wAMD ENVISION study will compare UBX1325 administered in a repeat dose regimen to standard-of-care aflibercept in patients with early persistent retinal fluid and visual acuity deficits,” said Jamie Dananberg, M.D., chief medical officer of UNITY. “As the first senolytic treatment being explored for retinovascular diseases, we believe UBX1325 may improve visual function and lessen the significant treatment burden imposed on patients through a biological pathway distinct from, but complementary to, anti-VEGF treatment.”

About UBX1325

UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), wet age-related macular degeneration (wAMD), 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 preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UBX1325 has shown a favorable safety profile and improvements in visual acuity sustained through 24 weeks following a single dose in a Phase 1 clinical study in advanced vascular eye disease. 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.