Extended Phase 2b ASPIRE Study for UBX1325 in Diabetic Macular Edema

In a recent advancement, a biotechnology firm has extended the duration of a pivotal clinical trial to enhance the evaluation of a novel treatment for diabetic macular edema (DME). The ASPIRE study, which was initially set to last for 24 weeks, has been expanded to 36 weeks to better assess the longevity of the effects of UBX1325, a drug developed by UNITY Biotechnology, Inc. The study size has also been increased from 40 to 50 participants to bolster its statistical significance.

The ASPIRE study's primary aim is to compare the safety, efficacy, and long-term effectiveness of UBX1325 against aflibercept, a standard treatment for DME. UBX1325 is a unique candidate in its field as it targets senescent cells, which are believed to contribute to aging-related diseases. The drug is a small molecule inhibitor of Bcl-xL, a protein that senescent cells depend on for survival. In previous studies, UBX1325 has shown promising results in improving vision with sustained effects.

The extension of the ASPIRE study is expected to yield two sets of data: the primary endpoint data after 24 weeks, which is slated for release in the first quarter of 2025, and the long-term extension data after 36 weeks to be disclosed in the second quarter of the same year. The company is confident that its current financial resources will support its operations through the third quarter of 2025.

The ASPIRE study is a multi-center, randomized, and double-masked trial that will assess the performance of UBX1325 in comparison to aflibercept. Approximately 50 subjects with active DME who are not experiencing optimal benefits from standard care will be enrolled. They will be randomly assigned to receive either UBX1325 or aflibercept injections every eight weeks for six months. Notably, there will be no treatments scheduled between weeks 24 and 36 to directly compare the durability of the two treatments.

The primary efficacy measure will be the non-inferiority of UBX1325 to aflibercept, as determined by the mean change from baseline in Best Corrected Visual Acuity (BCVA) at week 24. Secondary measures will include changes in BCVA and Central Subfield Thickness (CST) over time, as well as the proportion of participants who do not require additional anti-VEGF treatments up to week 36.

UNITY is dedicated to developing a new class of therapeutics aimed at slowing, halting, or reversing aging-related diseases. The company's focus is on medicines that selectively target senescent cells to provide significant benefits in ophthalmologic and neurologic conditions. More information about UNITY and its mission can be found on their official website and social media platforms.

The investigational compound UBX1325 is not yet approved for any use and is currently being studied for its potential in treating retinal diseases, including DME. The drug has demonstrated a significant improvement in BCVA in the Phase 2 BEHOLD study, and preclinical studies have shown that it selectively eliminates senescent cells from diseased tissue while preserving healthy cells. UNITY's vision with UBX1325 is to revolutionize patient outcomes in retinal disease treatment.