UNITY Biotechnology Presentations at ARVO 2022 Showcase UBX1325 as an Investigational Novel Therapeutic Modality for Retinal Vascular Diseases

Rhea-AI Summary

UNITY Biotechnology announced significant findings at the ARVO 2022 Annual Meeting regarding its investigational drug UBX1325 for diabetic macular edema (DME) and wet age-related macular degeneration (AMD). The Phase 1 study showed that most patients experienced rapid improvements in best corrected visual acuity (BCVA) and maintained central subfield thickness over 24 weeks. A symposium discussed the role of cellular senescence in ocular diseases, reinforcing the potential of UBX1325 as a transformative treatment. Initial results from Phase 2 studies are expected later this year.

Positive

• Majority of advanced DME and wet AMD patients treated with UBX1325 showed rapid and sustained improvements in BCVA.
• The drug demonstrated a favorable safety profile during the Phase 1 study.
• Potential to serve as a disease-modifying therapeutic option against standard anti-VEGF treatments.

Negative

• None.

Cellular senescence biology in eye disease was a focal point at ARVO opening symposium

SOUTH SAN FRANCISCO, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, announced presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting featuring UBX1325 as a potential treatment for diabetic macular edema (DME) and wet age-related macular degeneration (AMD), as well as the role of cellular senescence in retinal vascular diseases. A summary of UBX1325 Phase 1 study was presented, and a symposium on the role of cellular senescence in ocular disease were both featured this week to more than 10,000 ophthalmologists and other experts in attendance.

The presentation titled, “UBX1325, a novel senolytic treatment for patients with advanced DME or wet AMD: 24-week results of a phase 1 study,” was presented by Robert Bhisitkul, M.D., Ph.D., professor of ophthalmology and director of the Retina Fellowship at 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 sustained improvements in best corrected visual acuity (BCVA) and maintained or improved central subfield thickness (CST) through the duration of the study, which was 24 weeks.

Additionally, a symposium titled, “Cellular senescence and immune response in ocular health and disease,” featured 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 pathway. As demonstrated in preclinical studies, Bcl-xL is highly expressed in diseased blood vessels during retinopathy, which have been shown to engage pathways of cellular senescence. The inhibition of Bcl-xL by UBX1325 selectively promotes elimination of senescent cells in the retina in preclinical models, which leads to improvements in vascular leakage and retinal function, including improvements to both neovascular and avascular areas.

“Featured as an opening symposium for ARVO, cellular senescence biology is capturing the interest of physician researchers in ophthalmology and retinal disease as a potentially important driver of disease progression, positioning senolytics as a promising new approach for treating retinal vascular diseases,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “A majority of 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 anti-VEGF standard of care treatment. I look forward to sharing initial data results from the Phase 2 BEHOLD and ENVISION studies of UBX1325 later this year.”

12-week safety and efficacy data from the ongoing Phase 2 BEHOLD study in DME is anticipated by mid-year 2022, and 24-week data is anticipated before year-end 2022. 16-week safety and efficacy data from the ongoing Phase 2 ENVISION study in wet AMD is anticipated by year-end 2022.

Full presentations are available virtually to ARVO participants, while a recording of the symposium talks will be available on the ARVO website on May 11, 2022.

About UBX1325

UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), age-related macular degeneration (AMD), and diabetic retinopathy (DR) that is not 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 eye disease, UBX1325 has shown a favorable safety profile and improvements in visual acuity sustained through 24 weeks following a single dose. In preclinical studies, UNITY has 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 transformationally improve real-world outcomes for patients with DME, AMD, and DR.

About UNITY

UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of results of our studies of UBX1325, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. We may not actually achieve 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 in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to 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 the business of UNITY in general, see UNITY’s most recently filed Annual Report on Form 10-K for the year ended 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.

Media Contact
Canale Communications
Jason Spark
Jason.spark@canalecomm.com

Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com

FAQ

What were the key findings from UNITY's press release about UBX1325?

The Phase 1 study of UBX1325 showed that most patients with advanced DME or wet AMD experienced rapid improvements in visual acuity and maintained retinal thickness over 24 weeks.

What is UBX1325 being studied for?

UBX1325 is being investigated for treating age-related diseases of the eye, specifically diabetic macular edema and age-related macular degeneration.

When can we expect more data from the Phase 2 studies of UBX1325?

Initial data from the Phase 2 BEHOLD and ENVISION studies of UBX1325 are anticipated to be shared later in 2022.

What is the significance of cellular senescence in eye diseases according to UNITY's presentation?

Cellular senescence is viewed as a major driver of disease progression in ocular diseases, which positions senolytic therapies like UBX1325 as promising treatment options.