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Unity Biotechnology announces complete 36-week results from Phase 2b ASPIRE
UNITY Biotechnology announced complete 36-week results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema who had poor vision despite prior anti-VEGF treatment. The Company previously disclosed 24-week and interim 36-week results from its ASPIRE trial, demonstrating that UBX1325 was non-inferior to aflibercept at most time points through 36 weeks, except for the average of weeks 20 and 24, the primary endpoint. Phase 2b ASPIRE study results from all subjects through 36 weeks: Non-inferior visual gains in Best-Corrected Visual Acuity compared to leading anti-VEGF product; UBX1325 was statistically non-inferior to aflibercept at week 36; UBX1325 generally outperformed aflibercept in subjects who had moderately aggressive disease. Favorable safety and tolerability profile: UBX1325 continues to demonstrate a favorable safety and tolerability profile across multiple clinical studies to date; There have been no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis across multiple studies
Unity Biotechnology announces publication in NEJM on Phase 2 BEHOLD study
UNITY Biotechnology announced that the peer-reviewed journal NEJM Evidence published results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema. As reported in the article titled, "Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema," the results suggested that the selective clearance of senescent cells in the retina provided disease-modifying and long-lasting improvements in vision in patients with DME, supporting the potential of UBX1325 as a novel modality for retinal diseases.
Unity Biotechnology reports Q1 EPS (43c), consensus (40c)
Cash, cash equivalents and marketable securities totaled $16.9M as of March 31 compared with $23.2M as of December 31, 2024. Unity believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the fourth quarter of 2025. "The 24-week data indicates that UBX1325, acting via a novel mechanism of action, can lead to vision improvement in patients with inadequate response to standard of care," said Anirvan Ghosh, chief executive officer of Unity. "The full 36-week data will be instrumental in shaping our plans for subsequent studies."
Unity Biotechnology announces results from ASPIRE Phase 2b study in DME
UNITY Biotechnology announced topline results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema who had poor vision despite prior anti-VEGF treatment. The study results include data from all patients through 24 weeks, and the majority of patients through 36 weeks. UBX1325 treatment led to visual acuity gains of over 5 letters from baseline at weeks 24 and 36, and achieved non-inferiority to aflibercept at 9 out of 10 time points through 36 weeks, except for the average of weeks 20 and 24, where it achieved non-inferiority at an 88% confidence interval. Phase 2b ASPIRE Topline Results from all subjects through 24 weeks and the majority of subjects through 36 weeks: Non-inferior visual gains in Best-Corrected Visual Acuity compared to leading anti-VEGF product; UBX1325-treated patients had a mean change in BCVA of +5.2 ETDRS letters from baseline to 24 weeks, representing a difference of +0.4 ETDRS letters compared to the aflibercept arm; UBX1325-treated patients had a mean change in BCVA of +5.5 ETDRS letters from baseline to 36 weeks, representing a difference of +0.2 ETDRS letters compared to the aflibercept arm; UBX1325 was non-inferior to aflibercept at all time points through 36 weeks, except for the average of weeks 20 and 24; Patients on UBX1325 had an increase in Central Subfield Thickness at weeks 16 and 20, which resulted in supplemental anti-VEGF treatments in patients with significant CST gain; Sub-groups with consistent and durable vision gains with UBX1325; UBX1325 generally outperformed aflibercept in patients who had moderate disease severity; Patients who switched from aflibercept as their anti-VEGF treatment prior to study enrollment to UBX1325 had the most consistent and durable vision gains; Favorable safety and tolerability profile; UBX1325 continues to demonstrate a favorable safety and tolerability profile across multiple clinical studies to date; There have been no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis across multiple studies. UBX1325 is a novel BCL-xL inhibitor that is designed to eliminate senescent cells in diabetic retinal blood vessels, while leaving healthy ones intact. UBX1325 is administered via intravitreal injections that are standard procedure in clinical practice, minimizing treatment complexity and reducing the challenges of adapting to other technologies or surgical procedures. UNITY anticipates the complete 36-week data results of the remaining patients in the second quarter of 2025.
Unity Biotechnology appoints Hashad to board of directors
UNITY Biotechnology announced that Yehia Hashad, M.D., executive vice president of research and development and chief medical officer at Bausch + Lomb, has been appointed to the Company's board of directors and as a member of its science committee.
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