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Unity Biotechnology (UBX) Earnings Call Presentation
2025-07-04 08:42
UBX1325 ASPIRE Study Results - UBX1325 showed a BCVA gain of 5.2 letters at week 24 and 5.5 letters at week 36[5] - Approximately 40% of UBX1325 patients did not require supplemental anti-VEGF treatment through week 36[5] - UBX1325 generally outperformed Aflibercept in subjects with less aggressive disease (baseline CST < 400 µm)[39] - Patients switching from Aflibercept to UBX1325 experienced consistent gains in BCVA and less variable CST[5, 39] - UBX1325 was non-inferior to Aflibercept at most time points through 36 weeks, but did not meet non-inferiority at the average of weeks 20 and 24 in the primary analysis[5] Market Opportunity and Unmet Needs in DME - The global Diabetic Macular Edema (DME) market is projected to reach $9.6 billion by 2031, with the US market reaching $5.5 billion[43] - Over 50% of patients discontinue anti-VEGF treatment by 6 months[43] - 58% of patients with DME exhibit suboptimal response to anti-VEGF therapies[43] - 28% of patients require frequent dosing (every 4 weeks) with current anti-VEGF treatments[43]
UNITY Biotechnology Announces Complete 36-Week Results from the ASPIRE Phase 2b Study of UBX1325 in Diabetic Macular Edema and Provides Corporate Updates
Globenewswire· 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]
UNITY Biotechnology to Present at the ARVO 2025 Annual Meeting
Globenewswire· 2025-05-01 12:00
Core Insights - UNITY Biotechnology, Inc. is set to present 36-week data from the ASPIRE Phase 2B study at the ARVO 2025 Annual Meeting, focusing on therapeutics aimed at diseases of aging [1] - The presentation will cover the safety and efficacy of the senolytic candidate UBX1325 for Diabetic Macular Edema, highlighting findings from the BEHOLD Phase 2 and ASPIRE Phase 2B trials [2] Company Overview - UNITY is developing a new class of therapeutics designed to slow, halt, or reverse diseases associated with aging, with a current focus on age-related ophthalmologic and neurologic diseases [3]
UNITY Biotechnology Appoints Industry Leader and Ophthalmology Expert Yehia Hashad, M.D., to the Board of Directors
Globenewswire· 2025-03-10 12:00
Core Insights - UNITY Biotechnology, Inc. has appointed Dr. Yehia Hashad to its board of directors and science committee, enhancing its leadership in ophthalmology as it prepares for the Phase 2b ASPIRE trial data readout for UBX1325 [1][2] Company Overview - UNITY is focused on developing therapeutics aimed at slowing, halting, or reversing diseases associated with aging, particularly in ophthalmologic and neurologic fields [4] Leadership and Expertise - Dr. Hashad brings over 25 years of experience in clinical and commercial drug development, having previously held leadership roles at Bausch + Lomb and Allergan Aesthetics, overseeing numerous pharmaceutical programs [2][3] - His expertise in ophthalmology is expected to be crucial for advancing UBX1325, a treatment for diabetic macular edema [2][3] Strategic Goals - The company aims to leverage Dr. Hashad's insights to optimize its strategy for UBX1325 and to develop a robust pipeline of future products targeting retinal diseases [2][3]