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September 20, 2022

Unity’s Phase II wet AMD therapy trial concludes subject enrolment

The company expects to report 16-week data from the trial in the first quarter of next year.

Unity Biotechnology has concluded subject enrolment in its Phase II ENVISION clinical trial of UBX1325 in wet age-related macular degeneration (AMD) patients. 

A total of 51 subjects were enrolled into the trial, exceeding the target by nearly 10%.

The randomised, multicentre, double-masked, active comparator-controlled trial is designed to assess the safety, efficacy, durability, and tolerability of two doses of UBX1325 versus aflibercept.

In the trial, subjects will be categorised into one of two trial arms to receive either two 10mcg doses of UBX1325 at weeks zero and four, or a total of four doses of 2mcg aflibercept given every eight weeks. 

Average variation in Best Corrected Visual Acuity (BCVA) and variation in CST from baseline at 16 and 24 weeks, as well as safety and tolerability, will be analysed as the trial’s outcome measures.

The company expects to report 16-week trial data in the first quarter of next year and 24-week data in the second quarter. 

An investigational compound, UBX1325 is a small molecule Bcl-xL inhibitor. 

It could hinder the function of proteins that senescent cells depend on for survival.

The compound is being analysed for age-related eye ailments including diabetic macular oedema (DME), AMD, and diabetic retinopathy.

Unity Biotechnology CEO Anirvan Ghosh said: “Completion of enrolment of the ENVISION study is an important milestone for Unity and illustrates the momentum and interest in the program as we continue to explore indications where UBX1325 could provide benefit beyond current standard of care. 

“UBX1325 is a first in class senolytic agent being studied as a treatment for retinal disease.” 

According to findings from the Phase II BEHOLD trial in DME patients, a single dose of UBX1325 offered a statistically significant and clinically meaningful improvement in mean BCVA at 12 and 18 weeks versus sham therapy.

In December 2020, the company dosed the first subject in a Phase I trial of UBX1325 to treat DME patients.

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