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UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 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 therapy.
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 switched from every 8-week aflibercept to a combination of aflibercept and UBX1325 at week 24 maintained vision gains achieved with aflibercept alone through week 48. Patients in a pre-specified subgroup with poor visual acuity at baseline (≤60 ETDRS letters) gained 3.2 ETDRS letters on combination treatment between weeks 24 and 48.
In the UBX1325 monotherapy arm, patients maintained visual acuity for the duration of the study, with a mean change of +0.1 ETDRS letters at the 24-week time point and a mean change of -1.5 ETDRS letters at 48 weeks. 40% of UBX1325-treated patients did not need anti-VEGF rescue through 48 weeks and 64% of the patients achieved an anti-VEGF treatment-free period of over 24 weeks. The median time to first anti-VEGF rescue was 32 weeks.
"The ENVISION study shows that patients with wet AMD who switch from anti-VEGF to UBX1325 can maintain visual acuity with a significant reduction in anti-VEGF treatment burden. Patients with more severe disease may benefit from a combination of aflibercept and UBX1325," said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. "At this time, we are fully directing our resources towards the DME program, where we saw a statistically significant improvement in visual acuity with monotherapy UBX1325 treatment in the Phase 2 BEHOLD study."
Additional 48-week data from the ENVISION study is expected to be presented at upcoming medical conferences. UNITY has initiated a Phase 2b study in patients with diabetic macular edema and expects to randomize the first patient in that study in Q4 2023.
Posted In: UBX
