UNITY Biotechnology has reported positive results from its ongoing Phase I clinical trial of its drug candidate, UBX1325, in advanced vascular eye disease patients.
The trial included patients with disease from diabetic macular oedema (DME) and wet age-related macular degeneration (AMD).
A small molecule, UBX1325 inhibits Bcl-xL and is said to be the first-ever senolytic therapy for ophthalmologic diseases.
It acts on a peculiar biologic pathway as compared to anti-VEGF treatments.
The open-label, single-ascending dose Phase I trial enrolled 12 subjects with advanced DME or wet AMD who were not benefiting from anti-VEGF treatments.
Participants who were part of the trial should not have received corticosteroid or an anti-VEGF treatment for three months before commencing UBX1325.
According to the 12-week data after treatment, UBX1325 was found to have a favourable safety profile, which supports progressing to further clinical trials.
The drug was well-tolerated, without any drug-associated adverse events or dose-limiting toxicities reported in the trial.
In vital clinical measures of disease progression, UBX1325 demonstrated continued responses in most subjects for 12 weeks.
These responses included significant enhancements in best-corrected visual acuity (BCVA) and central subfield thickness (CST).
The findings demonstrated robust and lasting responses after a single dose of UBX1325 through 12 weeks.
The latest data add substantively to the already reported eight-week results, which provided preliminary efficacy evidence.
UNITY Biotechnology CEO Anirvan Ghosh said: “We are excited by the trajectory of the data showing both a rapid response and sustained improvements in vision and retinal structure in most patients through 12 weeks following a single injection of UBX1325.
“The consistency of response at eight and 12 weeks suggests that the functional gains seen to date may be sustained beyond 12 weeks.
“These data further support our Phase IIa proof of concept study in patients with DME, which is already underway, and we anticipate the 12-week safety and efficacy data from that study in the first half 2022.”
The company anticipates reporting eight-week data from a group of wet AMD patients and the full 24-week data of the original group from the Phase I single ascending dose trial before the end of this year.
In July this year, UNITY reported positive results from the Phase I safety clinical trial of UBX1325 for the treatment of advanced vascular eye disease.