UNITY Biotechnology's Wet AMD Candidate Flunks On Non-Inferiority Threshold Compared To Regeneron's Drug

  • UNITY Biotechnology Inc 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 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.
  • Price Action: UBX shares are down 49.2% at $2.11 on the last check Monday.
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