Unity Biotechnology has reported topline outcomes from its randomised Phase IIb ASPIRE study of intravitreal UBX1325 for diabetic macular oedema.
The multi-centre trial is designed to evaluate the therapy in individuals who had poor vision in spite of previous anti-vascular endothelial growth factor (VEGF) treatment.
Data indicates that the therapy resulted in visual acuity gains and “achieved” non-inferiority to aflibercept at most time points through a 36-week period.
The trial included 52 participants who were randomised to receive either UBX1325 10μg or aflibercept 2mg control injections every eight weeks for a six-month period post-randomisation, with the primary efficacy endpoint being non-inferiority to aflibercept as evaluated by mean change from baseline in Best-Corrected Visual Acuity (BCVA) to the average of 20 and 24 weeks.
This double-masked study outcomes reveal that UBX1325-treated subjects experienced a mean change in BCVA of over five early treatment diabetic retinopathy study (ETDRS) letters from baseline at both 24 and 36 weeks.
Despite an increase in central subfield thickness in some UBX1325-treated subjects, which led to the supplemental anti-VEGF treatments, sub-groups showed “consistent and durable” vision gains.
UBX1325’s performance was particularly notable in those with moderate disease severity and those who had transitioned from aflibercept before trial enrolment.
The entire 36-week data for the remaining subjects in the trial is anticipated in the second quarter of this year.
Unity Biotechnology emphasises the ‘favourable’ safety and tolerability profile of the therapy, without any reported cases of intraocular inflammation or other severe side effects across several trials.
Unity Biotechnology CEO Anirvan Ghosh said: “The results also suggest that UBX1325 may provide greater vision gains than standard of care in patients with moderately aggressive disease.
“We look forward to advancing UBX1325 to late-stage studies against aflibercept in diabetic macular oedema patients with inadequate response to anti-VEGF therapies.”
UBX1325 is tailored for eliminating senescent cells in diabetic retinal blood vessels. The intravitreal injection method used for administering the therapy aligns with standard clinical practices.
Unity Biotechnology continues to study UBX1325 in retinal conditions.
