お知らせ • May 06
UNITY Biotechnology Announces Complete 36-Week Results from the ASPIRE Phase 2b Study of UBX1325 in Diabetic Macular Edema and Provides Corporate Updates
UNITY Biotechnology, Inc. announced complete 36-week results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME) 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 (BCVA) 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 (central subfield thickness (CST) <400 microns at baseline or at first run-in) 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, In conjunction with the full 36-week results, the Board of Directors has also approved a revised operating plan focused on evaluating strategic alternatives while reducing operational cash burn. As part of the operating plan, the Company will be implementing a reduction in force affecting all of its workforce, with certain consulting arrangements in place to close down the ASPIRE study. The Company intends to explore a full range of strategic alternatives, which may include, but are not limited to, the sale, license, monetization and/or divestiture of one or more of the Company’s assets and technologies (including UBX1325, the Tie2/aVEGF bispecific, and the Tie2 agonistic antibody), a strategic transaction, collaboration, partnership, merger, sale, or a winddown or dissolution of the Company. The Company’s Chief Executive Officer, Chief Financial Officer, and Chief Legal Officer will transition into consulting roles with the Company to support in evaluation of strategic alternatives and orderly transition of management roles. The Company may engage external advisors to support the evaluation of strategic alternatives. The Company's exploration of strategic alternatives may not result in the consummation of any transaction or the realization of any value for the Company or its shareholders. Portfolio Overview: UBX 1325 (BCL-xL inhibitor) Clinical data from the Phase 2 BEHOLD Study and the Phase 2B ASPIRE study in patients with DME demonstrate improvement in visual acuity with UBX1325 treatment. UBB 2048 (Tie2/aVEGF Bispecific), Preclinical data indicate strong Tie2 pathway activation and inhibition of VEGF pathways, as well as efficacy in models of retinal disease, with clinical candidate molecule. The molecule targets a validated pathway for treating DME and wet age-related macular degeneration (AMD), with best-in-class potential. UBX2050 (Tie2 agonistic antibody), Preclinical data indicates strong Tie2 pathway activation with clinical candidate molecule with therapeutic rationale for diseases of vascular permeability, including chronic kidney disease, diabetic nephropathy, and vascular dementia. Alpha-Klotho (biologic), Global license agreement with Jocasta Neuroscience, Inc. for development and commercialization in neurological indications, with development milestones, approval milestones, and sales-based royalties. Senescence and Aging biology IP portfolio: Broad and foundational patent portfolio in senescence and other age-related biology for multiple indications including ophthalmology, neurological diseases, pulmonary diseases, kidney-related diseases, cardiac and vascular diseases.