Phase 2 study shows benefit of UBX1325 in diabetic macular edema
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Key takeaways:
- Patients treated with UBX1325 experienced improvement in best corrected visual acuity from baseline.
- More than 50% of patients in the treatment arm did not require rescue treatment.
A single injection of UBX1325 helped patients with diabetic macular edema achieve improved best corrected visual acuity, according to a press release from Unity Biotechnology.
According to 48-week data from the phase 2 BEHOLD study, patients in the treatment arm had a mean change in BCVA of +6.2 letters from baseline, which was a difference of +5.6 letters compared with patients in the sham arm.
“Achieving sustained improvements in visual acuity and stabilization of retinal structure for almost 1 year after a single injection of UBX1325 is a remarkable result,” Anirvan Ghosh, PhD, CEO of Unity, said in the release. “UBX1325 is the only treatment candidate in clinical development that targets senescent cells to potentially modify the course of disease, and this therapeutic approach could redefine the standard of care in DME.”
In the study’s treatment arm, approximately 53% of patients went 48 weeks without requiring any anti-VEGF rescue treatment compared with 22% in the sham arm.
UBX1325 demonstrated a favorable safety and tolerability profile, and there were no reported cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis.
Unity expects to move forward with a phase 2b study evaluating UBX1325 against aflibercept later this year.