Unity Biotechnology announces upcoming trial data and new board of directors member

(Image Credit: AdobeStock/kenchiro168)

Unity Biotechnology announced 24-week topline data from the phase 2b ASPIRE study in diabetic macular edema (DME) are expected to be released in Q1 of 2025, with 36-week data expected in Q2 2025.

The Phase 2b ASPIRE study (NCT06011798) is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of foselutoclax (UBX1325) in a head-to-head comparison to aflibercept in the treatment of DME.

Primary outcome is the mean change from baseline in best-corrected visual acuity (BCVA) by early treatment diabetic retinopathy study (ETDRS) letter. Secondary outcomes include changes in BCVA (ETDRS letters) from baseline to each visit through week 36, change in central subfield thickness as measured in microns from baseline to each visit through week 36, and proportion of participants gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline in the study eye to week 36.²

Approximately 50 patients were enrolled and randomized 1:1 into either the foselutoclax arm, (10 μg given 8 weeks apart) or the control arm of aflibercept, (2 mg every 8 weeks).

Anirvan Ghosh, PhD, chief executive officer of Unity, commented on the expected results in a press release from the company.¹

“DME remains a significant unmet need, and we believe UBX1325 has the potential to provide a differentiated treatment option for patients who continue to experience vision loss despite current standard-of-care therapies. With its novel mechanism of action and durable therapeutic profile, UBX1325 could offer meaningful advantages over existing anti-VEGF treatments. The 24-week data as well as the 36-week data will be instrumental in shaping our plans for a potential pivotal trial and advancing our program,” said Ghosh.

Additionally, Unity Biotechnology also announced³ Yehia Hashad, MD, 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.

The company stated in a press release² that Hashad previously served as senior vice president and head of R&D for Allergan Aesthetics (Abbvie Company), in which he oversaw the development of more than 40 programs that spanned a wide range of pharmaceutical products.

Hashad commented on the new position in a press release from the company, saying, "I am thrilled to join UNITY at this pivotal moment and contribute to its mission to develop the next generation of therapeutics for retinal diseases. I look forward to collaborating with the UNITY team to advance the lead senolytic program and shape an exciting pipeline of future products."

Ghosh added insight into the appointment in the press release, saying, "Dr. Hashad is a highly respected leader in ophthalmology whose expertise will be invaluable as we prepare for the upcoming Phase 2b ASPIRE 24-week data readout and optimize our strategy to potentially advance UBX1325 to late-stage development. With over two decades of experience in clinical and commercial drug development, Dr. Hashad’s insights will be instrumental in positioning UBX1325 as a much-needed treatment option for patients with diabetic macular edema."

Reference:

1. UNITY Biotechnology, Inc. reports fourth quarter and full year 2024 financial results and business updates. Published March 7, 2025. Accessed March 13, 2025.https://ir.unitybiotechnology.com/news-releases/news-release-details/unity-biotechnology-inc-reports-fourth-quarter-and-full-year-5

2. Assess the efficacy and safety of repeat intravitreal injections of foselutoclax (UBX1325) in patients with DME (ASPIRE). clincaltrials.gov. NCT06011798. Accessed March 13, 2025. https://clinicaltrials.gov/study/NCT06011798?term=unity%20biotechnology&checkSpell=false&rank=7

3. UNITY Biotechnology appoints industry leader and ophthalmology expert Yehia Hashad, MD, to the board of directors. Published March 10, 2025. Accessed March 13, 2025. https://ir.unitybiotechnology.com/news-releases/news-release-details/unity-biotechnology-appoints-industry-leader-and-ophthalmology