Promising data has been released for a drug candidate demonstrating “vision gains that were comparable and statistically non-inferior to aflibercept at week 36” in a difficult-to-treat diabetic macular oedema (DMO) patient population.
UNITY Biotechnology said UBX1325 generally outperformed aflibercept in a pre-specified subgroup of patients with moderately aggressive disease (central subfield thickness (CST) <400 microns at baseline or at first run-in).1
The company said UBX1325 continued to demonstrate a favourable safety and tolerability profile and there have been no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis across multiple studies.
UBX1325’s demonstration of non-inferiority to aflibercept at 36 weeks and superior vision gains in the subgroup of patients with CST under 400 microns underscores its potential
The latest results are from the Phase 2b ASPIRE trial – a multi-centre, randomised, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active DMO who are not achieving optimal benefit from standard of care.
UBX1325 is an investigational compound, not approved for any use in any country. It is a potent small molecule inhibitor of BCL-xL, a member of the BCL-2 family of apoptosis regulating proteins.
UNITY CEO Dr Anirvan Ghosh said UBX1325 has demonstrated the potential to provide a “much-needed alternative treatment to anti-VEGF therapy through a completely novel mechanism of action”.
“UBX1325’s demonstration of non-inferiority to aflibercept at 36 weeks and superior vision gains in the subgroup of patients with CST under 400 microns underscores its potential to provide a valuable treatment option to patients.
“We believe that further development of UBX1325 would benefit from the capabilities of a company with an existing ophthalmic franchise, and we are exploring partnerships so that this programme can continue to be advanced as a potential new treatment,” Dr Ghosh said.
Reference
- UNITY Biotechnology, UNITY Biotechnology announces complete 36-week results from the ASPIRE Phase 2b study of UBX1325 in diabetic macular edema and provides corporate updates. News release 5 May 2025. Available at: biospace.com/press-releases/unity-biotechnology-announces-complete-36-week-results-from-the-aspire-phase-2b-study-of-ubx1325-in-diabetic-macular-edema-and-provides-corporate-updates [accessed May 2025].
