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UNITY Biotechnology Announces Complete 36-Week Results from the ASPIRE Phase 2b Study of UBX1325 in Diabetic Macular Edema and Provides Corporate Updates
Globenewswireยท 2025-05-05 12:00
Core Insights - UBX1325 demonstrated vision gains comparable and statistically non-inferior to aflibercept at week 36 in a difficult-to-treat diabetic macular edema (DME) patient population [1][3] - The company plans to explore strategic alternatives to advance UBX1325 and reduce operational cash burn [1][4] Clinical Trial Results - The Phase 2b ASPIRE study showed that UBX1325 was non-inferior to aflibercept at week 36, with superior vision gains in patients with central subfield thickness (CST) <400 microns [1][6] - The ASPIRE study enrolled 52 subjects, randomized to receive either UBX1325 or aflibercept every eight weeks for six months [9] Corporate Strategy - The Board of Directors approved a revised operating plan focused on evaluating strategic alternatives, which may include asset sales, licensing, or partnerships [4] - The company will implement a reduction in force affecting its entire workforce to support the new operating plan [4] Product Overview - UBX1325 is an investigational compound targeting retinal diseases, specifically DME, and is a potent small molecule inhibitor of BCL-xL [10] - The compound has shown a favorable safety and tolerability profile, with no cases of intraocular inflammation or other serious adverse events reported across multiple studies [6][10] Future Plans - The company is exploring partnerships to further develop UBX1325, aiming to leverage the capabilities of companies with existing ophthalmic franchises [3] - Full results from the ASPIRE study will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting [3]