Shares of UNITY Biotechnology (UBX, Financials) fell 33% to $1.22 as of 10:15 a.m. Eastern Time on Monday after the company reported topline results from a Phase 2b trial showing its investigational therapy UBX1325 achieved visual gains comparable to aflibercept in patients with diabetic macular edema.
UBX1325 averaged a 5.2 letter increase in best-corrected visual acuity at 24 weeks and a 5.5 letter increase at 36 weeks in the ASPIRE trial. With exception for the average of weeks 20 and 24, when it attained 88% confidence, the treatment met non-inferiority to aflibercept at more than 90% confidence at week 24. The business finds non-inferiority at nine of 10 time periods during 36 weeks.
According to UNITY, throughout trials UBX1325 shown a satisfactory safety and tolerability profile. Retinal artery blockage, endophthalmitis or vasculitis, were not recorded as causes of intraocular inflammation.
Defined as baseline central subfield thickness ≤ 400 microns, UBX1325 was quantitatively better than aflibercept at seven of ten time periods among patients with rather aggressive illness. Patients who had switched from aflibercept to UBX1325 before enrollment also demonstrated consistent and long-lasting visual improvements, UNITY stated.
Over a 24-week period, the ASPIRE study included 52 patients randomized to receive either 10 micrograms of UBX1325 or 2 milligrams of aflibercept every eight weeks. Data for every patient were gathered for 24 weeks and most for 36 weeks. For the remaining second quarter of 2025 UNITY anticipates total 36-week results.
Designed to kill senescent cells in diabetic retinal capillaries while protecting healthy cells, UBX1325 is a small chemical inhibitor of BCL-xL. It is given intra-visual injection.
