Tiziana宣布鼻腔给药 Foralumab在非活动性继发进展型多发性硬化症中的新阳性临床数据-动脉网

Tiziana Announces New Positive Clinical Data for Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis

Tiziana Life Sciences 等信源发布 2026-05-19 19:04

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Favourable trends seen in stability of disability and clinically meaningful improvements in fatigue.

残疾状况的稳定性以及疲劳方面有临床意义的改善趋势良好。

BOSTON, MA, May 19, 2026

美国马萨诸塞州波士顿，2026年5月19日

– Tiziana Life Sciences, Ltd. (Nasdaq:

– Tiziana Life Sciences, Ltd. (纳斯达克:

TLSA

) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces updated clinical data from its ongoing Expanded Access (“EA”) Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

）（“Tiziana”），一家开发现阶段主导候选药物——鼻腔给药的foralumab（一种全人源化抗CD3单克隆抗体）的生物技术公司，宣布了其正在进行的扩大使用（“EA”）计划的最新临床数据，该计划正在评估鼻腔给药的foralumab在14名非活动性继发进展型多发性硬化症（na-SPMS）患者中的效果。

The data, updated from March 2025 to as of March 2026, demonstrate that intranasal foralumab continues to be extremely well tolerated over extended treatment durations. Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)..

数据显示，从2025年3月更新至2026年3月的数据表明，长期治疗中，鼻腔给药的foralumab仍然具有极好的耐受性。患者在扩展残疾状态量表（EDSS）测量的残疾稳定方面表现出令人鼓舞的趋势，并在修正疲劳影响量表（MFIS）测量的疲劳方面显示出有意义的改善。

Study Highlights:

研究亮点：

Safety: Foralumab was well tolerated with no new safety signals identified.

安全性：Foralumab 耐受性良好，未发现新的安全信号。

EDSS Stabilization: We observed a favorable trend toward disease stabilization (i.e., reduced Confirmed Disability Progression (CDP).

EDSS稳定：我们观察到疾病稳定化的良好趋势（即，确诊残疾进展（CDP）减少）。

Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points in their MFIS score.

疲劳改善：64%的患者在MFIS评分中实现了≥4分的临床显著改善。

Figure 1. Foralumab Expanded Access Program vs. HERCULES Reference Arms

图1. Foralumab扩大使用计划与HERCULES参考组对比

The graph titled “Foralumab Expanded Access Program vs Hercules Reference Arms” compares the cumulative incidence of disability progression events in the foralumab EA cohort against the placebo and tolebrutinib arms from the Phase 3 HERCULES non-relapsing SPMS trial (

图表标题为“Foralumab扩大使用计划与Hercules参考组的对比”比较了Foralumab扩大使用（EA）队列与第三阶段HERCULES非复发性SPMS试验中的安慰剂和托勒布替尼组的残疾进展事件的累积发生率（

DOI: 10.1056/NEJMoa2415988

数字对象标识符：10.1056/NEJMoa2415988

). The foralumab line shows only a single event, indicating strong stabilization in the majority of treated patients. An “event” is defined per the Sanofi (Nasdaq:

）。foralumab 线条仅显示单一事件，表明大多数接受治疗的患者病情得到了显著稳定。 “事件”是根据赛诺菲（纳斯达克：定义的。

SNY

索尼

) NEJM publication as a sustained increase in EDSS of ≥1.0 point if baseline EDSS <5.0, or ≥0.5 points if baseline EDSS ≥5.0.

NEJM 发表的文章中定义为：如果基线 EDSS <5.0，则 EDSS 持续增加 ≥1.0 分；如果基线 EDSS ≥5.0，则持续增加 ≥0.5 分。

Figure 2. Modified Fatigue Impact Scale (MFIS) Score

图 2. 改良疲劳影响量表 (MFIS) 评分

The graph titled “Modified Fatigue Impact Scale (MFIS) Score” shows 9 out of 14 participants (64%) achieved a clinically meaningful improvement of ≥4 points on the MFIS, consistent with criteria established by Rooney et al. (

标题为“改良疲劳影响量表（MFIS）得分”的图表显示，14名参与者中有9人（64%）在MFIS上达到了≥4分的临床显著改善，这与Rooney等人建立的标准一致。

DOI: 10.1016/j.msard.2019.07.028

数字对象标识符：10.1016/j.msard.2019.07.028

）。

Due to the small sample size in the Expanded Access Program, foralumab data shown in Figs 1 and 2 are not statistically significant and represent a trend analysis only.

由于扩大使用计划中的样本量较小，图1和图2中展示的foralumab数据在统计学上不显著，仅代表一种趋势分析。

Dr. Howard L. Weiner, Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, and Chair of the Scientific Advisory Board of Tiziana Life Sciences, commented: “These longer-term results from the Expanded Access SPMS Program continue to support the potential of intranasal foralumab as a novel, immunomodulatory therapy for patients with non-active SPMS.

布拉姆和妇女医院安·罗姆尼神经疾病中心主任、蒂齐亚纳生命科学公司科学顾问委员会主席霍华德·L·韦纳博士评论道：“扩展使用SPMS计划的这些较长期结果继续支持鼻腔给药foralumab作为一种新型免疫调节疗法对非活动性SPMS患者的潜力。”

The excellent tolerability profile combined with trends toward disability stabilization and fatigue improvement is highly encouraging and warrants further investigation.”.

优异的耐受性特征，结合趋于稳定的残疾状况和疲劳改善的趋势，令人备受鼓舞，并值得进一步研究。

Ivor Elrifi, CEO of Tiziana Life Sciences, added: “We are pleased with the continued positive safety and clinical trend data from our Expanded Access Program. Intranasal foralumab’s unique mechanism, which reduces neuroinflammation, positions it as a potential new treatment paradigm for progressive forms of multiple sclerosis where treatment options remain limited.

Tiziana生命科学公司首席执行官Ivor Elrifi补充道：“我们很高兴看到我们的扩大使用计划持续传来积极的安全性和临床趋势数据。鼻腔给药的foralumab凭借其减少神经炎症的独特机制，有望成为治疗选择仍然有限的进展型多发性硬化症的一种潜在新疗法。”

We look forward to advancing this program to approval.”.

我们期待推进该计划获得批准。

About Foralumab

关于Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (.

Foralumab是一种全人源抗CD3单克隆抗体，作为一种生物候选药物，已被证明在鼻内给药时能够刺激T调节细胞。目前，已有14名非活动性继发进展型多发性硬化症（na-SPMS）患者在一个开放标签的中等规模扩大使用（EA）项目中接受了给药。

NCT06802328

) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (.

）所有患者在6个月内病情均得到改善或稳定。此外，鼻内给药的foralumab目前正在一项针对非活动性继发进展型多发性硬化症患者的2a期、随机、双盲、安慰剂对照、多中心、剂量范围试验中进行研究（。

NCT06292923

）。

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.

Foralumab是目前临床开发中唯一的全人源抗CD3单克隆抗体（mAb）。通过鼻内给药的Foralumab进行免疫调节，代表了治疗神经炎症和神经退行性人类疾病的新途径。

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About Tiziana Life Sciences

关于蒂齐亚娜生命科学

Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery.

Tiziana是一家临床阶段的生物制药公司，利用变革性的药物递送技术开发突破性疗法，以实现免疫治疗的替代途径。Tiziana创新的鼻腔给药方法相比静脉注射（IV）有可能在疗效以及安全性和耐受性方面提供改善。

Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications..

Tiziana的主打候选药物——鼻内给药的foralumab，是目前临床开发中唯一的全人源抗CD3单克隆抗体，在迄今为止的研究中已显示出良好的安全性和临床反应。Tiziana用于免疫治疗替代途径的技术已获得专利，还有多项申请正在审批中，预计可广泛应用于多种研发管线。

For more information about Tiziana and its innovative pipeline of therapies, please visit

有关Tiziana及其创新疗法管道的更多信息，请访问

www.tizianalifesciences.com

。

Forward-Looking Statements

前瞻性声明

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Tiziana’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements.

本公告中作出的某些声明为前瞻性声明。这些前瞻性声明并非历史事实，而是基于Tiziana当前对其行业、信念和假设的预期、估计和预测。诸如“预期”、“预计”、“意图”、“计划”、“相信”、“寻求”、“估计”等词语及类似表达旨在识别前瞻性声明。

These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Tiziana’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.

这些声明并非对未来表现的保证，且受到已知和未知风险、不确定性及其他因素的影响，其中部分因素超出Tiziana的控制范围，难以预测，可能导致实际结果与前瞻性声明中表达或预测的结果存在重大差异。

Tiziana cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of Tiziana only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission.

Tiziana警告证券持有者和潜在证券持有者不要过度依赖这些前瞻性陈述，这些陈述仅反映Tiziana截至本公告日期的观点。实际结果可能与这些前瞻性陈述所表明的结果存在重大差异，原因包括多种重要因素：与市场状况相关的不确定性以及其他因素，详见Tiziana截至2025年12月31日的年度报告中标题为“风险因素”的章节以及提交给证券交易委员会的其他定期报告中更全面描述的内容。

The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Tiziana will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any.

本公告中作出的前瞻性陈述仅与作出这些陈述之日的事件相关。Tiziana 不会承担任何公开发布对这些前瞻性陈述的修订或更新的义务，以反映在本公告日期之后发生的事件、情况或意外事件，除非法律或任何其他规定要求。

For further inquiries:

如需进一步查询：

Tiziana Life Sciences Ltd

蒂齐亚娜生命科学有限公司

Paul Spencer, Business Development, and Investor Relations

保罗·斯宾塞，业务发展与投资者关系

+44 (0) 207 495 2379

email:

电子邮件：

info@tizianalifesciences.com

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