("UNITY"), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced results from Part A of the Phase 2 ENVISION study of UBX1325 in patients with wet age-related macular degeneration (AMD) who were not achieving optimum benefit with their ongoing anti-VEGF therapy. UNITY Biotechnology Announces Results from Phase 2 ENVISION Study of UBX1325 in Patients with Wet Age-Related Macular Degeneration More than half (52%) of patients who received UBX1325 did not require anti-VEGF treatment throughout the 24 weeks of the trial, UNITY reported. Patients were already receiving aflibercept when they enrolled in the trial, but benefit from the therapy was not optimal, according to the press release. UBX1325 monotherapy, meanwhile, reduced letters by 0.8 from baseline. The 3.5-letter gain with aflibercept was mostly maintained for the study's duration. The trial used the Early Treatment Diabetic Retinopathy Study (ETDRS) to assess the therapies, which revealed an early and unexpected visual gain of 3.5 ETDRS letters with aflibercept, according to Unity. The trial involved 51 patients with wAMD who received either two 10 mcg doses of UBX1325 at week zero and week four or anti-VEGF agent aflibercept 2 mg every eight weeks. The 24-week data are from the Part A portion of the proof-of-concept Envision study of UBX1325, a Bcl-xL inhibitor. This sent the biotech's shares tumbling 46% in premarket trading on Monday. UNITY Biotechnology's lead asset, UBX1325, failed to show non-inferiority to Regeneron's anti- VEGF drug aflibercept in a Phase II wet age-related macular degeneration (wAMD) trial. UNITY Shares Nearly Halved after Lead Asset Fails to Match Regeneron's Eylea The conclusion adopted by the rest of the industry is that systemic, whole-body clearance of senescent cells is required to remove enough of the harmful effect of the senescence-associated secretory phenotype (SASP) on tissue function to produce meaningful gains for patients. Unfortunately for UNITY investors, the outcome has been a demonstration, first in the knee, and now in the eye, that localized removal of senescent cells produces some benefit, but not as much as hoped, and not enough to show a clear advantage in human trials. Adopting a localized injection strategy is a time-worn approach intended to make things easier with regulators, as the much lower, localized dose means that there is a greatly reduced risk of side-effects. UNITY Biotechnologies chose to pursue localized administration of senolytics in their initial phase 1 and phase 2 trials for both knee osteoarthritis and macular degeneration. The present consensus is that the senescent cells present in the rest of the body are producing a significant contribution by their signaling: those cells may be more distant, and their contributions thus more dilute, but there are a lot more of them. While adding senescent cells to a joint is sufficient to provoke the onset of osteoarthritis, clearing senescent cells from only the joint region is not sufficient to produce significant patient benefits. More information is available at or follow us on Twitter and LinkedIn.Most of the research relevant to the question of whether localized clearance of senescent cells can effectively treat age-related conditions has taken place in the context of osteoarthritis. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. UNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. The webcast of the presentation will be accessible here and through the “Investors and Media” section of our website, under “Events & Presentations.” (“UNITY”), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the Company’s Management will provide a corporate update and participate in one-on-one investor meetings at the SVB Securities Global Biopharma Conference on Wednesday, Februat 11:20 AM ET. 15, 2023 (GLOBE NEWSWIRE) - UNITY Biotechnology, Inc.
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