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Abivax股票因溃疡性结肠炎药物的试验数据而飙升

Abivax stock soars on trial data for ulcerative colitis drug

BioPharma Dive 等信源发布 2025-07-23 23:15

可切换为仅中文


Dive Brief:

简报:

Abivax’s shares soared more than 500% on Wednesday after the company released positive Phase 3 results for its experimental ulcerative colitis medicine.

Abivax公司的股价在周三飙升了500%以上,此前该公司发布了其试验性溃疡性结肠炎药物的积极第三阶段结果。

The Paris-based biotech conducted two studies of its drug, obefazimod, in patients with moderately to severely active ulcerative colitis who didn’t receive enough relief from prior therapies. The 50 milligram dose of the medicine achieved a pooled 16.4% placebo-adjusted clinical remission rate at week 8, better than what was reported in Phase 2 testing, Abivax .

总部位于巴黎的生物技术公司对其中度至重度活动性溃疡性结肠炎患者进行了两项研究,这些患者未从先前的治疗中获得足够的缓解。该药物 50 毫克剂量在第 8 周达到了 16.4% 的汇总安慰剂校正临床缓解率,优于 Abivax 在 2 期试验中的报告结果。

said

late Tuesday.

周二晚间。

Researchers are now conducting a 44-week maintenance trial that should yield topline results in the second quarter of next year. If those results are also positive, Abivax plans to submit applications to U.S. and European regulators in the second half of 2026.

研究人员目前正在进行一项为期44周的维持试验,预计将在明年第二季度得出主要结果。如果这些结果同样积极,Abivax计划在2026年下半年向美国和欧洲监管机构提交申请。

Dive Insight:

深入洞察:

Abivax’s drug is the first in its class and offers another way to treat a disease that is increasingly attracting attention from drugmakers.

Abivax的药物是其类别中的第一个,为一种日益引起制药商关注的疾病提供了另一种治疗方法。

Merck & Co.

默克公司

,

Roche

罗氏

,

Pfizer

辉瑞

and

Eli Lilly

礼来公司

have all spent billions of dollars in recent years to scoop up companies with experimental drugs to treat inflammatory conditions, including ulcerative colitis. Lilly is currently

近年来,为了收购拥有治疗包括溃疡性结肠炎在内的炎症性疾病的实验性药物的公司,已经花费了数十亿美元。礼来公司目前正处于

awaiting data

等待数据

from its experimental drug, MORF-057.

来自其试验性药物MORF-057。

The new Abivax studies have pushed obefazimod to the front of the field for oral drugs that treat inflammatory bowel disease, Leerink Partners analyst Thomas J. Smith wrote in a note to clients. The market for IBD, which includes both ulcerative colitis and Crohn’s disease, will reach $30 billion by 2030, Smith’s team at Leerink estimates..

Leerink Partners 分析师托马斯·J·史密斯在给客户的一份报告中写道,Abivax 的新研究已将奥贝扎莫德推到治疗炎症性肠病口服药物领域的前沿。史密斯的团队在 Leerink 估计,包括溃疡性结肠炎和克罗恩病在内的炎症性肠病市场将在 2030 年达到 300 亿美元。

Smith now forecasts Abivax’s candidate to generate peak sales of about $4 billion for both ulcerative colitis and Crohn’s disease, compared with an earlier estimate of $2.6 billion. Obefazimod has a “compelling balance of efficacy, safety and convenience,” Smith wrote.

史密斯现在预测,Abivax公司的候选药物在溃疡性结肠炎和克罗恩病方面的峰值销售额将达到约40亿美元,而之前的估计为26亿美元。史密斯写道,奥贝法齐莫德在“疗效、安全性和便利性之间有着令人信服的平衡”。

Abivax tested two doses in the ABTECT-1 and ABTECT-2 trials. The 50 milligram dose met its primary endpoints as well as all key secondary endpoints, the company said. The results for the 25 milligram dose did not reach statistical significance for clinical remission in the ABTECT-2 study, but the company said its pooled clinical response rate offered a “strong signal” that remission may come with longer treatment..

Abivax在ABTECT-1和ABTECT-2试验中测试了两种剂量。该公司表示,50毫克剂量达到了其主要终点以及所有关键的次要终点。25毫克剂量在ABTECT-2研究中未能达到临床缓解的统计学显著性,但该公司表示,其综合临床反应率提供了“强烈信号”,表明缓解可能会随着更长的治疗时间而实现。

More than 600 sites around the world are participating in the ABTECT study program, which includes 1,275 patients and is one of the largest ever undertaken in ulcerative colitis, Abivax said. The company’s shares jumped to about 56 euros on the

Abivax 表示,全球有超过 600 个地点正在参与 ABTECT 研究项目,该项目涵盖 1275 名患者,是针对溃疡性结肠炎进行的最大规模研究之一。公司股价上涨至约 56 欧元。

Paris exchange

巴黎交易所

Wednesday, after closing at 8.90 euros Tuesday.

周三,周二收盘价为8.90欧元。