Prothena报告早期阿尔茨海默病研究中非竞争性脑肿胀率-动脉网

Prothena Reports Non-Competitive Brain Swelling Rates In Early Alzheimer's Study

benzinga 等信源发布 2025-08-28 13:37

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Prothena Corporation plc

PRTA

港口监管和转运区

shared results

共享结果

on Wednesday from the Phase 1 ASCENT clinical program in participants with early symptomatic Alzheimer’s disease (AD).

周三，来自第一阶段ASCENT临床项目，针对早期症状性阿尔茨海默病（AD）的参与者。

As previously communicated, Prothena plans to explore potential partnership interest to advance PRX012 and its preclinical PRX012-TfR (transferrin receptor) antibody.

如之前所述，Prothena 计划探索潜在的合作伙伴关系，以推进 PRX012 及其临床前 PRX012-TfR（转铁蛋白受体）抗体的研发。

The Phase 1 ASCENT clinical program results demonstrated PRX012 as a potential once-monthly, subcutaneous anti-amyloid beta (Aβ) antibody with stable pharmacokinetics, low anti-drug antibodies, and low injection site reactions, as well as dose- and time-dependent

第一阶段ASCENT临床项目结果表明，PRX012作为一种潜在的每月一次皮下注射抗淀粉样蛋白β（Aβ）抗体，具有稳定的药代动力学、较低的抗药物抗体以及较低的注射部位反应，并且呈现剂量和时间依赖性。

reductions in amyloid plaque

淀粉样蛋白斑块的减少

。

At the 400 mg dose level, PRX012 demonstrated a mean reduction in amyloid PET to 27.47 centiloids (CL) at month 12; FDA-approved anti-Aβ antibodies have defined amyloid negativity thresholds of ≤30 CL or ≤24.1 CL.

在400毫克剂量水平，PRX012在第12个月时显示出淀粉样蛋白PET平均降低至27.47个单位（CL）；FDA批准的抗Aβ抗体定义的淀粉样蛋白阴性阈值为≤30 CL或≤24.1 CL。

However, PRX012 was associated with higher overall ARIA-E rates relative to FDA-approved anti-Aβ antibodies, making PRX012 less appropriate for the patients studied in the ASCENT clinical program.

然而，与FDA批准的抗Aβ抗体相比，PRX012与更高的总体ARIA-E发生率相关，这使得PRX012对于ASCENT临床项目中研究的患者来说不太适用。

When ARIA-E did occur, the characteristics were similar to those reported following treatment with other anti-Aβ antibodies.

当发生ARIA-E时，其特征与其他抗Aβ抗体治疗后报告的特征相似。

At 200 mg and 400 mg doses, 38.1% to 41.7% of patients had amyloid-related imaging abnormality-edema (ARIA-E), a swelling of the brain associated with anti-amyloid beta antibodies.

在200毫克和400毫克剂量下，38.1%至41.7%的患者出现了与抗淀粉样蛋白β抗体相关的脑部肿胀，即淀粉样蛋白相关影像学异常-水肿（ARIA-E）。

This compares with

这与以下内容进行比较：

Eisai Co Ltd

卫材株式会社

ESALY

易碎

and

和

Biogen Inc

渤健公司

BIIB

百健公司

, which previously

，之前

reported

已报告

a 13% rate of ARIA-E in a study of Leqembi.

在Leqembi的研究中，ARIA-E的发生率为13%。

In two

两秒钟内

Eli Lilly and Co

礼来公司

。

LLY

礼来公司

studies, 3% and 6% of patients

研究中，3% 和 6% 的患者

had

有

symptomatic ARIA-E.

有症状的ARIA-E。

Prothena called the ARIA-E profile in early symptomatic Alzheimer's 'non-competitive.'

Prothena称早期症状性阿尔茨海默病的ARIA-E特征为“非竞争性”。

Based on the profile observed in the ASCENT clinical program and feasibility work already completed on its preclinical Aβ-transferrin receptor antibody surrogate, Prothena believes this approach may represent an opportunity to significantly reduce the risk of ARIA and quickly decrease amyloid plaque with once-monthly subcutaneous administration..

基于在ASCENT临床项目中观察到的特征以及在其临床前Aβ-转铁蛋白受体抗体替代物上已完成的可行性工作，Prothena认为这种方法可能代表着一个显著降低ARIA风险并通过每月一次皮下注射快速减少淀粉样蛋白斑块的机会。

Initial preclinical studies have demonstrated substantially increased brain exposure and facilitated rapid targeting of Aβ plaques in an APP/PS1 transgenic mouse model.

初步临床前研究显示，在APP/PS1转基因小鼠模型中，显著增加了大脑暴露并促进了Aβ斑块的快速靶向。

Prothena, which initiated

Prothena，其发起的

a reduction of approximately 63%

大约减少63%

of its workforce

其劳动力的

in June, does not plan to share additional data from the ASCENT clinical program publicly. However, it expects to explore potential partnership interests to advance PRX012 and PRX012-TfR.

6月，不打算公开分享ASCENT临床项目的更多数据。但是，它希望探索潜在的合作伙伴关系，以推进PRX012和PRX012-TfR的发展。

In May, Prothena’s Phase 3 AFFIRM-AL trial for birtamimab in patients with AL amyloidosis did not meet its primary endpoint (HR=0.915, p-value=0.7680).

今年 5 月，Prothena 公司针对 AL 型淀粉样变性患者的 birtamimab 的 III 期 AFFIRM-AL 试验未达到其主要终点（HR=0.915，p 值=0.7680）。

Based on these results, the company discontinued the development of birtamimab, including stopping the open-label extension

基于这些结果，该公司停止了对伯他单抗的开发，包括停止开放标签扩展研究。

of the AFFIRM-AL trial

AFFIRM-AL 试验的

。

In August, Prothena announced that Novo Nordisk A/S

今年八月，Prothena公司宣布诺和诺德公司

NVO

expects to advance coramitug, a potential first-in-class amyloid depleter antibody, into a Phase 3 program for ATTR amyloidosis with cardiomyopathy (ATTR-CM) in 2025.

预计将在2025年将潜在的首创新药类淀粉蛋白清除抗体coramitug推进至针对伴有心肌病的转甲状腺素蛋白淀粉样变性（ATTR-CM）的第三阶段临床试验。

Coramitug was initially developed by Prothena and was acquired by Novo Nordisk in July 2021. Prothena is eligible to receive up to

Coramitug 最初由 Prothena 开发，并于 2021 年 7 月被诺和诺德收购。Prothena 有资格获得高达

$1.2 billion in milestone payments

12亿美元的里程碑付款

。

Price Action:

价格行为:

PRTA stock is down 0.75% at $8.49 at the last check on Thursday.

PRTA股票在周四最后一次检查时下跌了0.75%，至8.49美元。

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