UNITY Biotechnology Announces First Patient Dosed in Phase 1 Study of UBX1325 in Diabetic Macular Edema

UNITY Biotechnology announced that the first patient has been dosed in a phase 1 study of UBX1325 in patients with diabetic macular edema (DME).

“There is strong evidence of association between disease progression in DME and accumulation of senescent cells. There’s additional evidence that senescent cells secrete factors that can be damaging to the eye and lead to vascular leakage, a pathological hallmark of DME,” Anirvan Ghosh, PhD, chief executive officer of UNITY, said in a company news release. “Bcl-xL inhibition, a novel senolytic mechanism, has been shown in our preclinical tests to lead to an impact on senescent cells, reduction in vascular leakage, and improvement in retinal function. Our preclinical observations give us confidence in UBX1325 and we are excited to bring this therapeutic candidate into clinical development.”

The phase 1, first-in-human, open-label, single-ascending dose study is designed to evaluate the safety, tolerability and pharmacokinetics of UBX1325 in patients with advanced DME. The trial is designed to enroll approximately 15 patients, with safety and tolerability data expected in the first half of 2021. UNITY anticipates initiating a proof of concept study in the first half of 2021.

About UBX1325

UBX1325 is a potent and selective small molecule inhibitor of Bcl-xL, an anti-apoptotic regulatory protein and a BCL-2 family member. Preclinically, UBX1325 has been shown to eliminate senescent cells and have a positive impact on inflammation, vascular leakage and visual function. UBX1325 is currently being evaluated in a first-in-human trial designed to treat patients with advanced diabetic macular edema.

To learn more about the phase 1 clinical trial of UBX1325, visit clinicaltrials.gov.