SOUTH SAN FRANCISCO – UNITY Biotechnology, Inc. [NASDAQ: UBX], a biotech firm focused on developing treatments for age-related diseases, announced Monday an extension of its Phase 2b ASPIRE study for UBX1325 from 24 to 36 weeks to evaluate its potential for longer-lasting effects in comparison to aflibercept. The study's expansion from 40 to 50 patients aims to enhance statistical significance.
The ASPIRE study contrasts the safety, efficacy, and durability of UBX1325 as a stand-alone therapy against aflibercept in patients with diabetic macular edema (DME). UNITY's CEO, Dr. Anirvan Ghosh, highlighted previous significant vision improvements and durability in patients treated with UBX1325 in the BEHOLD proof-of-concept study. UBX1325 is unique in clinical development for DME as it targets senescent cells, offering a novel mechanism that could sustain vision acuity improvements and reduce treatment frequency.
The study extension will result in two sets of topline results: primary endpoint data at 24 weeks expected in the first quarter of 2025, and long-term data at 36 weeks in the second quarter of 2025. UNITY believes its financial reserves will fund operations into the third quarter of 2025.
ASPIRE, a multi-center, randomized, double-masked, active-controlled trial, will assess UBX1325's safety and efficacy against aflibercept in DME patients who have not optimally benefited from existing treatments. Approximately 50 participants will receive either 10 µg UBX1325 or 2 mg aflibercept control injections every eight weeks for six months.
No treatments are scheduled between weeks 24 and 36 to allow a direct durability comparison. The primary efficacy measure is the non-inferiority of UBX1325 to aflibercept based on the mean change in Best Corrected Visual Acuity (BCVA) at week 24.
UBX1325, a potent Bcl-xL inhibitor, has shown significant and clinically meaningful improvement in mean BCVA through 48 weeks in the BEHOLD study compared to a sham treatment. It aims to selectively eliminate senescent cells from diseased tissue, potentially transforming treatment outcomes for retinal diseases.
This news is based on a press release statement from UNITY Biotechnology, Inc.
InvestingPro Insights
UNITY Biotechnology, Inc. [NASDAQ: UBX] has been making strides with its clinical studies, but what do the financials say? According to InvestingPro data, the company's market capitalization stands at a modest $24.84 million, reflecting a niche player in the biotech industry. The valuation metrics reveal a challenging financial landscape with a negative P/E ratio of -0.73 for the last twelve months as of Q4 2023, which indicates that the company is not currently profitable. Moreover, the gross profit margin during this period was in the red at -$19.7 million, underscoring the high costs associated with research and development in the biotech sector.
When it comes to the company's liquidity, one of the InvestingPro Tips points out that UNITY holds more cash than debt on its balance sheet, which is a positive indicator of financial stability. This is particularly important for biotech firms like UNITY that are in the growth phase and require substantial funding for research and development. However, the same InvestingPro Tips also highlight a rapid cash burn and weak gross profit margins, which could be areas of concern for potential investors. Analysts contributing to InvestingPro do not anticipate UNITY will be profitable this year, and the company’s valuation implies a poor free cash flow yield.
For those interested in diving deeper into the financial health and future prospects of UNITY Biotechnology, InvestingPro offers additional tips and insights. Currently, there are 6 more InvestingPro Tips available, which can be accessed at https://www.investing.com/pro/UBX. For readers looking to take advantage of these expert analyses, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.