UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that the peer-reviewed journal NEJM Evidencepublished results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). As reported in the article titled, “Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema,” the results suggested that the selective clearance of senescent cells in the retina provided disease-modifying and long-lasting improvements in vision in patients with DME, supporting the potential of UBX1325 as a novel modality for retinal diseases.
“By targeting senescent cells, we expect to remodel the retinal vasculature, which should lead to improvements in retinal function,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY and an author of the paper. “We see the impact of this approach in action in the BEHOLD study, in which patients experienced meaningful and sustained improvements in their visual acuity for 1 year after a single injection of UBX1325. By selectively targeting an underlying cause of inflammation and disease progression, senolytic therapies could provide a valuable future treatment.
Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema
RESULTS
Between June 2021 and April 2022, 65 participants (32.3% women) were randomly assigned to either UBX1325 (n=32) or sham (n=33). There were four TEAEs of Grade 3 or greater in the sham group, of which three were considered serious, while there were five in the UBX1325 group of Grade 3 or greater and considered serious. There were no apparent between-group differences with respect to vital signs, electrocardiograms, or routine blood chemistries. For the secondary outcome of efficacy, the difference between UBX1325 and sham in mean change to week 48 in best corrected visual acuity was 5.6 more ETDRS letters (95% confidence interval, −1.5 to 12.7).
CONCLUSIONS
In this sham-controlled trial there were no TEAEs that led to discontinuation of treatment with UBX1325 compared with sham. There were trends suggestive of potential efficacy; larger trials are needed to further evaluate these findings. (Funded by UNITY Biotechnology; ClinicalTrials.gov number, NCT04857996.)