2/10/2024 0 Comments Unity xcode iconWe 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. 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. 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, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of enrollment and results of the clinical trials in UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. More information is available at follow us on Twitter and LinkedIn. 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. UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. ![]() UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. ![]() 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. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean Best Corrected Visual Acuity (BCVA) through 48 weeks compared to sham treatment. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis regulating proteins. UBX1325 is an investigational compound being studied in retinal diseases including DME and wet AMD and is not approved for any use in any country. ![]() More information about ASPIRE (NCT06011798) can be found here. Initial 16-week data is expected in the fourth quarter of 2024 and 24-week data expected in the first quarter of 2025. Secondary endpoints will include change in BCVA over time, and central subfield thickness (CST) change from baseline to week 24. ![]() The primary efficacy endpoint will be mean change from baseline in Best Corrected Visual Acuity (BCVA) to week 24. It is expected to enroll about 40 subjects who will be randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months. We look forward to sharing initial results from the study in the fourth quarter of 2024.”ĪSPIRE is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active diabetic macular edema (DME) who are not achieving optimal benefit from standard of care. “There has been great interest from the physician community in the therapeutic potential of UBX1325, which is based on a novel senolytic mechanism of action, and we are excited to have dosed our first patients in the ASPIRE study. “Many patients with DME have poor vision despite frequent anti-VEGF injections and there is an urgent need to develop new treatment options for such patients,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. (“UNITY”), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patients have been dosed in the Phase 2 ASPIRE study of UBX1325 (foselutoclax), a Bcl-xL inhibitor being evaluated head-to-head against standard of care anti-VEGF in patients with diabetic macular edema (DME). 12, 2023 (GLOBE NEWSWIRE) - UNITY Biotechnology, Inc.
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