![]() Patients treated with UBX1325 had a mean change in CST of +3.2 microns from baseline compared to +53.5 microns in sham-treated patients (p=0.0719)īased on pre-defined proof-of-concept criteria of alpha=0.15, the study demonstrated a statistically significant treatment effect for both BCVA and CST at both 12- and 18-weeks.Patients treated with UBX1325 had a mean improvement in BCVA of +6.1 ETDRS letters from baseline compared to +1.1 EDTRS letters in sham-treated patients (p=0.0368).Patients treated with UBX1325 had a mean change in CST of -1.4 microns from baseline compared to +40.3 microns in sham-treated patients (p=0.0747)Īt 18 weeks (primary analysis set of 54 patients).Patients treated with a single injection of UBX1325 had a mean improvement in BCVA of +4.7 ETDRS letters from baseline compared to +1.3 ETDRS letters in sham-treated patients (p=0.1148).Patients enrolled in BEHOLD were receiving regular anti-VEGF treatment prior to enrollment into the study (mean rate of approximately 4 injections in the preceding 6 months) with the last anti-VEGF injection occurring 3 – 6 weeks prior to randomization.UBX1325 demonstrated a favorable safety and tolerability profile with no cases of intraocular inflammation, retinal vein occlusion, endophthalmitis, or vasculitis.Īt 12 weeks (primary analysis set of 65 patients) These data represent an important and exciting step in validating the senolytic therapeutic concept that is core to UNITY’s platform.”Įvidence of favorable safety, visual acuity improvement, and structural stability in a difficult-to-treat patient population: ![]() “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. “The 12- and 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 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 significant treatment burden on patients. 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. In addition, patients treated with UBX1325 maintained CST compared to sham-treated patients who demonstrated progressive worsening of CST (i.e., increased retinal thickness) through 18 weeks. (“UNITY”), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 12- and 18-week data from its Phase 2 BEHOLD study of UBX1325, a senolytic Bcl-xL inhibitor, in patients with diabetic macular edema (DME).Īt 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). 12, 2022 (GLOBE NEWSWIRE) - UNITY Biotechnology, Inc. UNITY to host investor call with retinal expert Robert Bhisitkul, M.D., Ph.D., today, August 12, at 8:00 a.m. The treatment effect was seen in a patient population with visual acuity deficits and residual retinal fluid despite frequent and recent anti-VEGF therapy UBX1325 treatment also stabilized retinal structure, as measured by central subfield thickness (CST) at 12- and 18-weeks, as compared to worsening in sham-treated patients A single injection of UBX1325 led to a progressive, statistically significant, and clinically meaningful improvement in mean Best Corrected Visual Acuity (BCVA) at 12- and 18-weeks compared to sham treatment
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