SOUTH SAN FRANCISCO, California, May 05, 2022 (GLOBE NEWSWIRE) – UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapies to slow, stop or reverse the diseases of aging, announced presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2022 annual meeting with UBX1325 as a potential treatment for macular edema diabetic (DME) and wet age-related macular degeneration (AMD), as well as the role of cellular senescence in retinal vascular disease. A summary of the UBX1325 phase 1 study was presented and a symposium on the role of cellular senescence in eye disease was presented to over 10,000 ophthalmologists and other experts this week.
The presentation titled “UBX1325, a new senolytic treatment for patients with advanced DME or wet AMD: 24-week results of a phase 1 study,” was presented by Robert Bhisitkul, MD, Ph.D., professor of ophthalmology and director of the Retina Scholarship at the University of California, San Francisco. As previously announced, the majority of patients with advanced DME or wet AMD treated with a single injection of UBX1325 showed rapid and lasting improvements in corrected visual acuity (BCVA) and maintained or improved central subfield thickness (CST) for the entire duration of the study, which was 24 weeks.
Additionally, a symposium titled “Cellular Senescence and Immune Response in Eye Health and Disease” saw the participation of leading researchers in the field who discussed the role of cellular senescence and aging in various eye diseases, as well as promising therapeutic approaches to target this path. As demonstrated in preclinical studies, Bcl-xL is highly expressed in diseased blood vessels during retinopathy, which have been shown to engage cellular senescence pathways. Inhibition of Bcl-xL by UBX1325 selectively promotes the elimination of senescent cells in the retina in preclinical models, which leads to improvements in vascular loss and retinal function, including improvements in both neovascular and avascular areas.
“Presented as the opening symposium for ARVO, cellular senescence biology is capturing the interest of medical researchers in ophthalmology and retinal diseases as a potentially important driver of disease progression, positioning senolytics as a promising new approach to treating vascular diseases of the retina, “said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Most of the subjects in our Phase 1 study in DME and wet AMD treated with our senolytic drug candidate, UBX1325, demonstrated rapid improvements in visual acuity, supporting the potential for UBX1325 to become a disease-modifying therapeutic option. for patients and an alternative approach to the anti-VEGF standard of care. I look forward to sharing the results of the initial data from the BEHOLD and ENVISION Phase 2 studies of UBX1325 later this year. “
12-week safety and efficacy data from the ongoing Phase 2 BEHOLD DME study are expected by mid-2022 and 24-week data are expected by the end of 2022. 16-week safety and efficacy data from the DME study Phase 2 ENVISION ongoing wet AMD study is expected by the end of 2022.
Full presentations are virtually available to ARVO attendees, while a recording of the symposium talks will be available on the ARVO website on 11 May 2022.
UBX1325 is an investigational compound under study for age-related eye diseases, including diabetic macular edema (DME), age-related macular degeneration (AMD) and diabetic retinopathy (DR) that do not it is approved for any use in any country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis-regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. In a Phase 1 clinical study in advanced vascular disease of the eye, UBX1325 showed a favorable safety profile and sustained improvements in visual acuity for 24 weeks after a single dose. In preclinical studies, UNITY demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformatively improve real-world outcomes for patients with DME, AMD and DR.
UNITY is developing a new class of therapies to slow, stop or reverse the diseases of aging. UNITY’s current goal is to create drugs to selectively eliminate or modulate senescent cells and thereby provide transformative benefits in age-related ophthalmological and neurological diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter and LinkedIn.
This press release contains forward-looking statements, including statements regarding UNITY’s understanding of cellular senescence and the role it plays in the diseases of aging, the potential for UNITY to develop therapies to slow, stop or reverse the diseases of aging, including for use ophthalmic and neurological diseases, our expectations regarding the potential benefits, activity, efficacy and safety of UBX1325, the potential for UNITY to successfully initiate and complete clinical trials of UBX1325 for DME, AMD and other ophthalmological diseases, expected timeline for results of our studies of UBX1325, the anticipated start, progression and end times of our studies, including those of UBX1325, and UNITY’s expectations regarding the sufficiency of its cash track. These statements involve known and unknown risks, uncertainties and other material factors that could cause our actual results, business levels, performance or results to differ materially from the information expressed or implied in these forward-looking statements, including the risk that the global pandemic COVID-19 may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or discontinuing patient enrollment in clinical trials, risks related to uncertainties inherent in the drug development process, and risks related to UNITY’s understanding of the biology of senescence. We may not actually realize the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements contained in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will change our views. However, while we may decide to update these forward-looking statements in the future, we have no intention of doing so except to the extent required by applicable law. Therefore, you should not rely on these forward-looking statements as representing our views at any date after the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to UNITY’s business in general, see UNITY’s latest annual report on Form 10 – K for the year ending December 31, 2021, filed with the Securities and Exchange Commission on March 15, 2022, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
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