The diabetic macular edema trial demonstrates favorable safety, improved visual acuity and structural stability in a difficult-to-treat patient population.
UNITY Biotechnology’s stock price soared following the announcement of 12- and 18-week data from its Phase 2 BEHOLD study in patients with diabetic macular edema (DME).
Longevity.Technology: UNITY, based in San Francisco, is a biotechnology company that develops therapies to slow, stop or reverse the diseases of aging. Its BEHOLD study is testing a senolytic inhibitor in patients with DME, a disease that affects one in 15 diabetics, or more than 20 million cases worldwide.
DME occurs when too much sugar in the blood damages the small blood vessels in the inner back wall of the eye, causing tiny bulges that leak fluid and blood into the retina, resulting in swelling ( edema); the result is vision problems or even blindness.
UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis regulatory proteins, and is designed to inhibit the function of proteins upon which senescent cells depend for survival. In preclinical studies, UNITY demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminates senescent cells from diseased tissue while sparing cells from healthy tissue. UNITY’s goal with UBX1325 is to dramatically improve real-world outcomes for patients with DME, Age-Related Macular Degeneration (AMD), and Diabetic Retinopathy (DR).
At 18 weeks after a single injection of UBX1325, the mean change in BCVA of subjects treated with UBX1325 was an increase of 6.1 ETDRS letters, representing an improvement of +5.0 ETDRS letters compared to subjects treated with fictional way. Additionally, patients treated with UBX1325 maintained CST compared to sham-treated patients who demonstrated progressive worsening of CST (indicated by increased retinal thickness) over 18 weeks.
At 12 weeks, a single injection of UBX1325 resulted in a mean improvement in BCVA of +4.7 ETDRS letters from baseline, compared to +1.3 ETDRS letters in the sham-treated patients.
Patients treated with UBX1325 had a mean change in CST of -1.4 microns from baseline compared to +40.3 microns in sham-treated patients [1].
UNITY suggests the trial results mean that one dose could have a lasting therapeutic effect, rather than the current standard of care for DME with the mainstay anti-VEGF treatment, which requires 3-5 monthly loading doses followed. of one dose every 8 weeks – placing a heavy treatment burden on patients.
“We are delighted with the recent data announced in our BEHOLD study in patients with DME and are grateful for the support and enthusiasm of our community of physicians and other stakeholders,” said Anirvan Ghosh, PhD, CEO of UNITY.
“The sustained and significant improvement in visual acuity after a single injection of UBX1325 is very impressive and, if approved, could be an attractive treatment option for patients who can currently only hope to maintain their vision at prices of frequent injections with the current standard of care,” he said, adding that UNITY is pleased to share its 24-week data in BEHOLD as it continues to investigate UBX1325, as well as data over 16 weeks in ENVISION, its wet age-related macular degeneration study. [2].
“The BEHOLD results at 12 and 18 weeks are particularly impressive considering that UBX1325 was administered as a single injection in a patient population in which anti-VEGF therapy was no longer providing optimal benefit,” said Ghosh, explaining that the observed vision gains were greater than those previously reported with standard of care in similar patient populations.
“The durability of effect suggests that UBX1325 may address the large unmet need for longer-lasting disease-modifying treatments for patients with DME. These data represent an important and exciting step in validating the senolytic therapeutic concept that is at the heart of the UNITY platform,” he added. [1].
Unity ended the second quarter with a cash balance of approximately $64.5 million; this should provide biotechnology with a track for the rest of this year and into the first quarter of 2023.
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[1] https://ir.unitybiotechnology.com/news-releases/news-release-details/unity-biotechnology-announces-positive-data-phase-2-behold-study
[2] https://ir.unitybiotechnology.com/news-releases/news-release-details/unity-biotechnology-inc-reports-second-quarter-2022-financial
