UNITY Biotechnology Inc (NASDAQ: UBX) announced results from Part A 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 treatment generally maintained visual acuity for six months, with most patients not requiring anti-VEGF rescue.
Patients in the every 8-week Rengeron Pharmaceuticals Inc (NASDAQ: REGN) Eylea (aflibercept) arm had an early and unexpected gain of 3.5 letters at week 2, which was mainly maintained for the duration of the study.
The study did not meet the non-inferiority threshold compared to aflibercept through 24 weeks.
The ENVISION study did not meet the non-inferiority margin of -4.5 letters compared to aflibercept with an 85% confidence interval.
UBX1325 demonstrated a favorable safety and tolerability profile.
Patients treated with UBX1325 had a mean change from baseline in BCVA of -0.8 ETDRS letters at 24 weeks compared to +3.1 ETDRS letters in the aflibercept control arm.
Patients treated with UBX1325 had a mean change from baseline in CST of +87.3 µm at 24 weeks compared to +30.5 µm in the aflibercept control arm.
The company will share 48-week BEHOLD DME data in April and intends to initiate Phase 2b study in DME in the second half of 2023.
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