UNITY Biotechnology Announces Additional Data from Phase 1 Study of UBX1325 in Advanced Vascular Eye Disease

February 14, 2022 at 8:00 AM EST

24-week UBX1325 Phase 1 data presented at Angiogenesis, Exudation, and Degeneration 2022 Conference  

Patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) showed improvement in visual acuity through 24 weeks following single dose of UBX1325

Phase 2 clinical studies of UBX1325 currently enrolling patients with DME and wAMD

SOUTH SAN FRANCISCO, Calif., Feb. 14, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that 24-week clinical data from the Phase 1 study of UBX1325 was presented by Robert Bhisitkul, M.D., Ph.D., professor of ophthalmology and director of the Retina Fellowship at University of California, San Francisco, at the Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 conference on Saturday, February 12, 2022. Consistent with previously shared data, the majority of patients treated with UBX1325 showed rapid and sustained improvements in best corrected visual acuity (BCVA) and maintained or improved central subfield thickness (CST).

The presentation titled, “Phase 1 Study of Intravitreal UBX1325: A Novel Agent Against Retinal Cell Senescence in AMD and DME,” featured safety, efficacy, and durability data from the Phase 1 single ascending dose study of UBX1325 in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wet AMD), including data results from the AMD expansion cohort through 24 weeks, marking the study completion:

  • UBX1325 was well tolerated without signs of intraocular inflammation or other related ocular adversities
  • In DME, following a rapid improvement in BCVA, a mean improvement of 9.5 ETDRS letters from baseline at 6 months in the higher dose cohorts (5, 10 mcg) and 6.9 ETDRS letters from baseline at 6 months in all dose cohorts was observed
  • In AMD, following a rapid improvement in BCVA, there were improvements or stabilization of both BCVA and CST through 6 months post-injection
  • In both diseases, the majority of patients treated with UBX1325 showed durable improvement in vision and did not meet objective rescue criteria requiring standard of care anti-VEGF treatment
  • Among patients who received anti-VEGF rescue, there was minimal change in either mean BCVA or CST following treatment in all but one patient

“Patients with retinal vascular diseases like DME and AMD face a significant treatment burden with currently available therapies, which can result in poor or unsustainable long-term outcomes,” said Dr. Bhisitkul. “There is a great need for more durable effective treatments that help patients better manage their disease. The totality of the 24-week clinical data presented is encouraging as it supports the potential of UBX1325 as an alternative to anti-VEGF with a distinct mechanism of action.”

Anirvan Ghosh, Ph.D., chief executive officer of UNITY, commented, “The full 24-week clinical data shows a rapid improvement in visual acuity from a single treatment of UBX1325 in advanced patients with DME and wet AMD who had received prior standard of care anti-VEGF therapy. We anticipate 12-week data from our ongoing Phase 2a study in DME by mid-2022 and 16-week data from our ongoing Phase 2 study in wet AMD in the fourth quarter of 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 preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UBX1325 has shown a favorable safety profile and improvements in visual acuity sustained through 24 weeks following a single dose in a Phase 1 clinical study in advanced vascular eye disease. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with DME, AMD, and DR.

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 recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 10, 2021, 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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Source: Unity Biotechnology, Inc.