Unity Biotechnology has dosed the first subjects in the Phase II ASPIRE clinical trial of its investigational small molecule Bcl-xL inhibitor, UBX1325 (foselutoclax), to treat diabetic macular oedema (DME) patients.
The randomised, multicentre, double-masked, active-controlled trial will assess the safety and efficacy of UBX1325 versus aflibercept in 40 active DME patients who were treated previously.
Patients who have not attained ideal benefit from standard of care will be part of the trial.
Trial subjects will be randomised into a 1:1 ratio to receive either 10μg injections of UBX1325 or control treatment of 2mg aflibercept every eight weeks for a total of six months.
Mean variation in Best Corrected Visual Acuity (BCVA) at week 24 from baseline will be the primary efficacy endpoint of the trial.
Variation in BCVA over a set period, as well as central subfield thickness (CST) from baseline to week 24, will comprise the trial’s secondary endpoints.
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The company anticipates reporting preliminary 16-week results from the trial in the fourth quarter of next year, and 24-week findings will be reported in the first quarter of 2025.
UBX1325 is being analysed to treat retinal ailments, such as DME and wet age-related macular degeneration (AMD).
It can hinder the activity of proteins that are vital for the survival of senescent cells.
Unity Biotechnology CEO Anirvan Ghosh said: “Many patients with DME have poor vision, despite frequent anti-VEGF injections, and there is an urgent need to develop new treatment options for such patients.
“There has been great interest from the physician community in the therapeutic potential of UBX1325, which is based on a novel senolytic mechanism of action, and we are excited to have dosed our first patients in the ASPIRE study.”
According to data from the Phase II BEHOLD trial of UBX1325 in DME patients, a single dose of the treatment provided mean BCVA improvement through the 48 weeks versus a placebo.