UNITY Biotechnology Reports Encouraging Results From Phase 2 ENVISION Study Of UBX1325

(RTTNews) - UNITY Biotechnology, Inc. (UBX) Wednesday reported results from Part B of the Phase 2 ENVISION study of UBX1325 in patients with wet age-related macular degeneration (AMD) who were not achieving optimum benefit with their ongoing anti-VEGF (Vascular endothelial growth factor) therapy.

The Phase 2 ENVISION study is designed to evaluate the safety, tolerability, efficacy and durability of a repeat intravitreal injection of UBX1325 and aflibercept in patients with neovascular AMD evaluated through 48 weeks.

Regeneron Pharmaceuticals' aflibercept is approved for the treatments of various eye diseases including AMD.

Patients enrolled for the ENVISION study, who had been on anti-VEGF treatment for at least 6 months, received a single shot of aflibercept at the beginning.

These patients were randomized into two arms, with people in the one arm got four injections of UBX1325 over 48 weeks. Patients in the control arm received an injection of aflibercept every 8 weeks. Additionally, these patients received UBX1325 two times through the duration of the 48-week study.

Results from the study showed that UBX1325 demonstrated a favorable safety and tolerability profile in the combination and monotherapy arms with no cases of significant intraocular inflammation, retinal artery occlusion or endophthalmitis.

Patients who switched from aflibercept alone to a combination of aflibercept and UBX1325 maintained vision gains achieved with aflibercept alone through week 48. Greater vision improvement were observed in patients with more severe disease.

40% of UBX1325-treated patients did not require anti-VEGF treatment through 48 weeks and 64% achieved an anti-VEGF treatment-free interval of over 24 weeks.

UNITY said it has initiated a Phase 2b study of UBX1325 in patients with diabetic macular edema and expects to randomize the first patient in that study in the fourth quarter of 2023.