UBX Stock Down 29% on Mixed Results From Phase II Eye Disease Study

Core Viewpoint - Shares of UNITY Biotechnology (UBX) fell by 28.8% following mixed results from a mid-stage study comparing its candidate UBX1325 to Regeneron's Eylea in diabetic macular edema (DME) patients [1] Group 1: Study Results - The phase IIb ASPIRE study aimed to demonstrate non-inferiority of UBX1325 to Eylea, measured by mean change in Best Corrected Visual Acuity from baseline to weeks 20 and 24 [2] - The study included 52 DME patients with poor vision despite prior anti-VEGF treatment, randomized to receive either 10 μg UBX1325 or 2 mg Eylea [2] - At weeks 24 and 36, patients treated with UBX1325 showed a +5.2 letter improvement in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks, indicating vision gains non-inferior to Eylea [3] Group 2: Statistical Analysis - UBX1325 demonstrated statistically significant non-inferiority to Eylea at all time points up to 36 weeks, except for the average of weeks 20 and 24, where it met non-inferiority at an 88% confidence interval, just below the 90% threshold [4] - Year to date, shares of UNITY Biotechnology have increased by 33.1%, compared to the industry's growth of 5.6% [4] Group 3: Safety and Efficacy - UBX1325 showed a favorable safety and tolerability profile across multiple clinical studies, with no reported cases of intraocular inflammation or other serious adverse events [7] - Patients with moderate disease severity (baseline CST less than 400 microns) showed better performance with UBX1325, comprising about 60% of the study population [6] Group 4: Competitive Landscape - Eylea, developed by Regeneron, is a leading drug for various eye diseases, already approved for multiple conditions including DME and wet age-related macular degeneration [8]