Foselutoclax

SOUTH SAN FRANCISCO, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that the peer-reviewed journal NEJM Evidence published results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). As reported in the article titled, “Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema,” the results suggested that the selective clearance of senescent cells in the retina provided disease-modifying and long-lasting improvements in vision in patients with DME, supporting the potential of UBX1325 as a novel modality for retinal diseases. “By targeting senescent cells, we expect to remodel the retinal vasculature, which should lead to improvements in retinal function,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY and an author of the paper. “We see the impact of this approach in action in the BEHOLD study, in which patients experienced meaningful and sustained improvements in their visual acuity for 1 year after a single injection of UBX1325. By selectively targeting an underlying cause of inflammation and disease progression, senolytic therapies could provide a valuable future treatment option for DME patients.” As previously disclosed and presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, a single injection of the senolytic candidate UBX1325 led to a statistically significant and clinically meaningful improvement in vision with extended durability through 48 weeks in patients with advanced DME. UNITY is currently conducting a Phase 2b ASPIRE study to evaluate multiple doses of UBX1325 in a head-to-head comparison to aflibercept. Topline 24-week and 36-week data was disclosed on March 24, 2025 and full 36-week data is expected in the second quarter of 2025. About the BEHOLD StudyThe proof-of-concept Phase 2 BEHOLD study is a multi-center, randomized, double-masked, sham-controlled study designed to evaluate the safety, tolerability, efficacy and durability of a single 10 mcg dose of UBX1325 in patients with DME. The study enrolled 65 patients who, despite being on anti-VEGF treatment for at least 6 months, displayed persistent visual acuity deficits (73 ETDRS letters, approximately 20/40, or worse) and residual retinal fluid (CST ≥300 microns). At baseline, patients in the study had an average visual acuity of 61.4 ETDRS letters and a CST of approximately 439.6 microns. In the 6 months prior to study enrollment, patients received an average of 4 anti-VEGF injections, with the last anti-VEGF injection occurring 3-6 weeks prior to randomization. Fifty patients completed the 48-week study extension. More information about the study is available here (NEJM Evidence) and here. About UBX1325 UBX1325 is an investigational compound being studied in retinal diseases, including DME, and 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. 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 BCVA through 48 weeks compared to sham treatment. 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. Multiple doses of UBX1325 are currently being evaluated in the ASPIRE Phase 2b study for people with DME who are not achieving optimal benefit from anti-VEGF drugs (NCT06011798). UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. About UNITYUNITY 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 X and LinkedIn. Forward-Looking StatementsThis 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, UNITY’s expectations regarding potential benefits, activity, effectiveness, safety, and market opportunity of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME and other ophthalmologic diseases, the expected timing of results of the clinical trial in 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 risks related to delay or disruption in clinical trials, risks relating to the uncertainties inherent in the drug development process, risks relating to UNITY’s understanding of senescence biology, and risks related to UNITY’s ability to raise funding. This press release also contains data from third parties relating to market size and treatment outcomes, which involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. The Company may not actually achieve the plans, intentions, or expectations disclosed in its 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 and the sufficiency of its cash runway, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission on April 22, 2025, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission. Media ContactInizio Evoke CommsKatherine SmithKatherine.Smith@inizioevoke.com Investor ContactLifeSci Advisors, LLCJoyce Allairejallaire@lifesciadvisors.com

在最近进行的两项关键临床试验中，Opthea的Sozinibercept和Unity的UBX1325均未能在疗效上击败或匹配再生元（Regeneron）的Eylea（阿柏西普）。这一结果对这两家公司来说无疑是巨大的挑战，尤其是在市场竞争日益激烈的眼科疾病治疗领域。 临床数据对比 1. Opthea的Sozinibercept： Opthea的Sozinibercept是一种新型的VEGF受体融合蛋白，旨在通过靶向VEGF-A和PlGF来治疗湿性年龄相关性黄斑变性（wAMD）和其他视网膜疾病。具体数据显示，Sozinibercept在最佳矫正视力（BCVA）和中央视网膜厚度（CST）这两个关键指标上均未能显著优于Eylea。 •  COAST III期研究招募了近1000名患者，这些患者接受了为期4周或8周的Sozinibercept治疗。一年后，在视力图表上测量的平均年龄变化分别为13.5和12.8个字母，而单独使用Eylea上的人则为13.7个字母。这相当于p值分别为0.86和0.42，这意味着与单独使用Eylea相比，联合治疗并没有显著改善视力。 2. Unity的UBX1325 UBX1325是一种靶向Bcl-xL的小分子抑制剂，用于治疗糖尿病性黄斑水肿（DME）。在II期临床试验中，UBX1325也未能在疗效上超越Eylea。 • 从基线到24周，ubx1325治疗的患者BCVA平均变化为+5.2 ETDRS字母，与阿非利西普组相比，差异为+0.4 ETDRS字母 • 从基线到36周，ubx1325治疗的患者BCVA平均变化为+5.5 ETDRS字母，与阿布利西普组相比，差异为+0.2 ETDRS字母 • 除了第20周和第24周的平均值外，UBX1325在36周的所有时间点都不逊于afliberept • 使用UBX1325的患者在第16周和第20周时中心亚野厚度（CST）增加，这导致CST显著增加的患者补充抗vegf治疗 尽管UBX1325在一些次要终点上显示出一定的潜力，但在主要疗效指标上仍未达到预期目标。当天Unity股价下跌28.77%！ 再生元公司的阿柏西普（Eylea）业务去年营收达 59 亿美元。该药物获批用于包括湿性年龄相关性黄斑变性和糖尿病性黄斑水肿在内的一系列病症。去年，阿柏西普的首个生物类似药已上市。 结束语： 再生元的Eylea自上市以来一直是眼科疾病治疗领域的主导药物之一，尤其是在湿性黄斑变性和糖尿病性黄斑水肿等适应症中。此次Opthea和Unity的试验结果进一步巩固了Eylea的市场地位。与此同时，Opthea和Unity面临着巨大的市场压力，需要重新评估其研发策略和产品管线。 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。