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Vaxxinity宣布2024年AD/PD™帕金森病1期临床试验的阳性靶点参与数据

Vaxxinity Announces Positive Target Engagement Data from Phase 1 Clinical Trial for Parkinson’s Disease at AD/PD™ 2024

GlobeNewswire 等信源发布 2024-03-07 23:32

可切换为仅中文


LISBON, Portugal, March 07, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ: VAXX), a U.S. company pioneering the development of a new class of medicines, announced positive clinical data from its UB-312 program in Parkinson’s disease (PD) presented by Jean-Cosme Dodart, PhD, SVP of Research at Vaxxinity in an oral session at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease, held virtually and in Lisbon, Portugal from March 5 to March 9, 2024.

葡萄牙里斯本,2024年3月7日(环球通讯社)--Vaxxinity,Inc.(纳斯达克代码:VAXX),一家开创新型药物开发的美国公司,宣布了由Jean Cosme Dodart博士介绍的帕金森病(PD)UB-312项目的积极临床数据,在2024年3月5日至3月9日于葡萄牙里斯本举行的AD/PD™2024阿尔茨海默病和帕金森病国际会议上,Vaxxinity的研究高级副总裁参加了一次口头会议。

UB-312 is the first active immunotherapy candidate to show reduction of pathological alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of PD patients. UB-312 is designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies. As part of the randomized, double-blind, placebo-controlled Phase 1 clinical trial, The Michael J.

UB-312是第一个显示PD患者脑脊液(CSF)中病理性α-突触核蛋白(aSyn)减少的主动免疫治疗候选者。UB-312旨在靶向聚集形式的aSyn,这是PD和其他突触核蛋白病的有毒物质。作为随机、双盲、安慰剂对照的1期临床试验的一部分,迈克尔J。

Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients, and to conduct exploratory research to assess target engagement. The UB-312-induced antibodies showed preferential binding to aggregated aSyn and almost no binding to normal monomeric aSyn, as measured by dot blot.

福克斯基金会(MJFF)资助了一个为期2年的合作项目,该项目由Vaxxinity、梅奥诊所和UTHealth Houston组成,旨在分析从患者身上收集的脑脊液,并进行探索性研究以评估目标参与度。通过斑点印迹测量,UB-312诱导的抗体显示出与聚集的aSyn的优先结合,而与正常单体aSyn几乎没有结合。

After a single priming regimen, those treated with UB-312 in the 300/100/100µg dosing group showed a 20% decrease from baseline in aggregated aSyn in the CSF compared to a 3% increase in the placebo group (p<0.05), as measured by a Seed Amplification Assay (SAA). Further, a post hoc analysis showed that patients with detectable UB-312-induced antibodies in the CSF exhibited improvement in activities of daily living as measured by the MDS-UPDRS II clinical scale (p<0.01).

单次引发方案后,300/100/100µg剂量组中用UB-312治疗的患者CSF中聚集的aSyn比基线降低了20%,而安慰剂组增加了3%(p<0.05),通过种子扩增试验(SAA)测量。此外,事后分析显示,通过MDS-UPDRS II临床量表测量,脑脊液中可检测到UB-312诱导抗体的患者日常生活活动有所改善(p<0.01)。

These data also suggest a correlation between reduction in aggregated aSyn in the brain and change.

这些数据还表明,大脑中聚集的aSyn减少与变化之间存在相关性。