“Unity Biotechnology Announces Positive Data in Phase 2 BEHOLD Study of UBX1325 in Patients With Diabetic Macular Edema”, 2022-08-12 ():
A single injection of UBX1325 led to a progressive, statistically-significant, and clinically meaningful improvement in mean Best Corrected Visual Acuity (BCVA) at 12/18-weeks compared to sham treatment
UBX1325 treatment also stabilized retinal structure, as measured by central subfield thickness (CST) at 12/18-weeks, as compared to worsening in sham-treated patients
The treatment effect was seen in a patient population with visual acuity deficits and residual retinal fluid despite frequent and recent anti-VEGF therapy
Unity Biotechnology, Inc., a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 12/18-week data from its Phase 2 BEHOLD study of UBX1325, a senolytic Bcl-xL inhibitor, in patients with diabetic macular edema (DME).
At 18 weeks after a single UBX1325 injection, the mean change in BCVA of UBX1325-treated subjects was an increase of 6.1 ETDRS letters, representing an improvement of +5.0 ETDRS letters compared to sham-treated subjects (p = 0.0368). In addition, patients treated with UBX1325 maintained CST compared to sham-treated patients who demonstrated progressive worsening of CST (ie. increased retinal thickness) through 18 weeks. The separation of UBX1325-treated patients from sham-treated patients at 18 weeks in measures of both visual function and retinal structure following a single UBX1325 injection suggests that one dose could have a durable therapeutic effect. The current standard of care for DME with the leading anti-VEGF therapeutic requires 3–5 monthly loading doses followed by every 8-week dosing, imposing a statistically-significant treatment burden on patients.
“The 12/18-week BEHOLD results are especially impressive considering that UBX1325 was given as a single injection in a patient population in which anti-VEGF treatment was no longer providing optimal benefit”, said Anirvan Ghosh, Ph.D., chief executive officer of Unity. “The vision gains observed are greater than what has been previously reported with the standard of care in similar patient populations, and the durability of effect suggests that UBX1325 could address the large unmet need for longer-lasting, disease-modifying treatments for patients with DME. These data represent an important and exciting step in validating the senolytic therapeutic concept that is core to Unity’s platform.”