UNITY Biotechnology Announces First Patient Dosed in Phase 1 Study of UBX1325 in Diabetic Macular Edema
UNITY Biotechnology (NASDAQ:UBX) has announced that the first patient has been dosed in a Phase 1 study of UBX1325 for diabetic macular edema (DME). The study aims to evaluate the safety and pharmacokinetics of UBX1325, targeting the elimination of senescent cells to address DME complications. Approximately 15 patients will be enrolled, with initial safety results expected in early 2021. The CEO emphasized the potential of UBX1325 based on promising preclinical data, indicating its role in reducing vascular leakage and improving retinal function.
- First patient dosed in Phase 1 study of UBX1325 targeting DME.
- Positive preclinical data suggest UBX1325 improves retinal function.
- Study designed to evaluate safety and tolerability in 15 patients.
- Possible enrollment delays due to COVID-19 pandemic.
- No immediate financial metrics provided regarding the trial.
SAN FRANCISCO, Oct. 12, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology (“UNITY”) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today announced that the first patient has been dosed in a Phase 1 study of UBX1325 in patients with diabetic macular edema (DME).
“There is strong evidence of association between disease progression in DME and accumulation of senescent cells. There’s additional evidence that senescent cells secrete factors that can be damaging to the eye and lead to vascular leakage, a pathological hallmark of DME,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Bcl-xL inhibition, a novel senolytic mechanism, has been shown in our preclinical tests to lead to an impact on senescent cells, reduction in vascular leakage, and improvement in retinal function. Our preclinical observations give us confidence in UBX1325 and we are excited to bring this therapeutic candidate into clinical development.”
The Phase 1, first-in-human, open-label, single-ascending dose study is designed to evaluate the safety, tolerability and pharmacokinetics of UBX1325 in patients with advanced DME. The trial is designed to enroll approximately 15 patients, with safety and tolerability data expected in the first half of 2021. UNITY anticipates initiating a proof of concept study in the first half of 2021.
About UBX1325
UBX1325 is a potent and selective small molecule inhibitor of Bcl-xL, an anti-apoptotic regulatory protein and a BCL-2 family member. Preclinically, UBX1325 has been shown to eliminate senescent cells and have a positive impact on inflammation, vascular leakage and visual function. UBX1325 is currently being evaluated in a first-in-human trial designed to treat patients with advanced diabetic macular edema. To learn more about the Phase 1 clinical trial of UBX1325, please visit the clinicaltrials.gov website here.
About UNITY
UNITY is developing a new class of therapeutics to slow, halt or reverse age-related diseases. 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 and follow us on LinkedIn and Twitter.
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 retinal diseases, the potential for UNITY to develop therapeutics to extend healthspan, including UBX1325 for retinal disease, the design of the UNITY’s Phase 1 study of UBX1325, the expected timing of initial study results of the Phase 1 study, and the expected timing of the commencement of a proof of concept study for UBX1325. 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. 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 the Company in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Commission on July 31, 2020, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
Investors
Endurance Advisors
Mike Zanoni
mzanoni@enduranceadvisors.com
Media
Canale Communications
Jason Spark
Jason.spark@canalecomm.com
FAQ
What is the purpose of the Phase 1 study for UBX1325?
What are the expected outcomes from the UBX1325 trial?
What is UBX1325 designed to treat?
When was the first patient dosed in the UBX1325 study?
What are the next steps following the Phase 1 trial of UBX1325?
