UNITY Biotechnology Inc. (NASDAQ: UBX) has announced that 24-week clinical findings from the first phase trial of UBX1325 were presented at the Bascom Palmer Eye Institute Angiogenesis Execution and Degeneration 2022 Conference on February 12, 2022, by professor of ophthalmology and director of the Retina Fellowship at University of California, San Francisco, Robert Bhisitkul.
Latest results consistent with previous results
Most of the patients who received UBX1325 demonstrated rapid and persistent reductions in optimum corrected visual acuity (BCVA) and retained or enhanced central subfield thickness, which was consistent with earlier published data.
The presentation, titled “Phase 1 Study of Intravitreal UBX1325: A Novel Agent Against Retinal Cell Senescence in AMD and DME,” included data from the first Phase single ascending dosages study of UBX1325 in the treatment of diabetic macular edema (DME) and wet age-related macular degeneration.
UBX1325 was well tolerated by the patients, with no evidence of intraocular inflammation or other ocular side effects. Following substantial progress in BCVA, the high dose cohorts (5, 10 mcg) had an average improvement of 9.5 ETDRS letters from baseline at six months, while all dose cohorts had an average improvement of 6.9 ETDRS letters from baseline at six months. Following a quick improvement in BCVA, both BCVA and CST improved six months after injection.
Patients experienced long-term visual improvement
In both conditions, most of the patients treated with UBX1325 experienced long-term visual improvement and did not fulfill objective rescue criteria needing anti-VEGF medication.
Dr. Bhisitkul said, “Patients with retinal vascular diseases like DME and AMD face a significant treatment burden with currently available therapies, which can result in poor or unsustainable long-term outcomes.”
CEO Anirvan Ghosh said, “The full 24-week clinical data shows a rapid improvement in visual acuity from a single treatment of UBX1325 in advanced patients with DME and wet AMD who had received prior standard of care anti-VEGF therapy. We anticipate 12-week data from our ongoing Phase 2a study in DME by mid-2022 and 16-week data from our ongoing Phase 2 study in wet AMD in the fourth quarter of 2022.”
