UNITY Biotechnology Inc. (NASDAQ: UBX) has announced twelve- and eighteen-week findings from the Phase 2 BEHOLD trial of UBX1325, its seneolytic Bcl-xL inhibitor, in treating diabetic macula edema patients.
UNITY reports the mean difference between UBX1325 treated patients and placebo
The mean difference in BCVA of UBX1325-treated participants at 18 weeks following a single injection was an improvement of 6.1 ETDRS letters, which represented an increase of +5.0 ETDRS letters in comparison to placebo-treated subjects (p = 0.0368). In contrast to placebo-treated patients, who showed gradual deterioration of CST (i.e., increased retinal thickness) over the course of 18 weeks, patients given UBX1325 retained CST.
After a single UBX1325 injection, there was a difference between UBX1325-treated patients and placebo-treated clients at 18 weeks in assessments of both sensory acuity and retina structure, indicating that one dose may have a long-lasting therapeutic effect. The leading anti-VEGF therapeutic’s current format of therapy for DME calls for 3-5 monthly loading dosages followed by 8-week dosing, placing a major strain on patients.
CEO of UNITY Anirvan Ghosh said, “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. 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.”
UBX1325 demonstrated favorable tolerability profile
With no instances of endophthalmitis, endophthalmitis, vasculitis, or intraocular inflammation, UBX1325 showed a satisfactory safety and tolerability profile. The business thinks UBX1325 might be a much-needed substitute for all existing DME treatments presently in use, including the gold standard anti-VEGF therapy.
“The 12- and 18-week results indicate that a single injection of UBX1325 resulted in significantly greater letter gains and stabilization of retinal structure than the sham treatment, but also likely altered the disease trajectory of these patients who had been on anti-VEGF treatment.”