Tiziana宣布其II期INFORM-MS试验中最后一名患者成功给药-动脉网

Tiziana Announces Last Patient Successfully Dosed in its Phase 2 INFORM-MS trial

Tiziana Life Sciences 等信源发布 2026-06-25 19:06

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Top line data readout expected in late Q3/early Q4

预计第三季度末至第四季度初公布顶层数据读数

INFORM-MS trial is a randomized, double-blind, placebo-controlled Phase 2a trial using Intranasal Foralumab in patients with Non-Active Secondary Progressive Multiple Sclerosis

INFORM-MS 试验是一项随机、双盲、安慰剂对照的 IIa 期临床试验，旨在评估鼻用 Foralumab 在非活动性继发进展型多发性硬化症患者中的疗效。

BOSTON, MA, June 25, 2026

马萨诸塞州波士顿，2026年6月25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 that the last patient in its ongoing Phase 2a clinical trial has received their first dose of intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

（“Tiziana”），一家正在开发其领先候选药物——鼻用foralumab（一种全人源抗CD3单克隆抗体）的生物技术公司，宣布其正在进行的2a期临床试验中的最后一位患者已接受首剂鼻用foralumab，用于治疗非活动性继发进展型多发性硬化症（na-SPMS）。

Topline data is expected in late Q3/early Q4 of 2026, and is planned to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and ECTRIMS meeting in Toronto, Canada in October 2026..

预计2026年第三季度末/第四季度初获得主要数据，并计划在2026年10月于加拿大多伦多举行的第十届美洲多发性硬化症治疗与研究联合委员会（ACTRIMS）与欧洲多发性硬化症治疗与研究委员会（ECTRIMS）联合会议上公布。

The randomized, double-blind, placebo-controlled Phase 2a trial, known as INFORM-MS (

这项随机、双盲、安慰剂对照的2a期临床试验，称为INFORM-MS（

NCT06292923

), is evaluating the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo in up to 48 patients with na-SPMS. The study includes multiple U.S. investigational sites and focuses on both imaging biomarkers and clinical outcomes.

），正在评估鼻用foralumab两种剂量与安慰剂相比，在多达48名非活动性继发进展型多发性硬化（na-SPMS）患者中的安全性、耐受性和疗效。该研究涵盖美国多个研究中心，并重点关注影像学生物标志物和临床结局。

Final dosing is underway across multiple leading U.S. clinical sites, including Brigham and Women’s Hospital, Johns Hopkins University, Weill Cornell Medicine, Yale MS Center, and others. The primary endpoint of the trial is the change in microglial activation as measured by positron emission tomography (PET) scans, with additional clinical evaluations including the Expanded Disability Status Scale (EDSS), quality of life assessments, and the Modified Fatigue Impact Scale (MFIS)..

最终给药正在美国多家领先临床中心进行，包括布里格姆妇女医院、约翰斯·霍普金斯大学、威尔康奈尔医学院、耶鲁大学多发性硬化症中心等。该试验的主要终点是通过正电子发射断层扫描（PET）测量的微胶质细胞激活变化，其他临床评估包括扩展残疾状态量表（EDSS）、生活质量评估以及改良疲劳影响量表（MFIS）。

“Participating as Principal Investigator in the INFORM-MS trial has been incredibly rewarding,” said Tanuja Chitnis, M.D., Principal Investigator and Senior neurologist at the Mass General Brigham Neuroscience Institute. “Intranasal foralumab represents a promising and innovative therapeutic strategy for patients with non-active secondary progressive MS.

“作为主要研究者参与 INFORM-MS 试验令人获益匪浅，”马萨诸塞州总医院布里格姆妇女医院神经科学研究所的主要研究者、高级神经学家 Tanuja Chitnis 博士表示。“鼻用 foralumab 为非活动性继发进展型多发性硬化症患者提供了一种充满前景且创新的治疗策略。”

We are encouraged by the smooth initiation of dosing across sites and look forward to evaluating its impact on microglial activation, and then further clinical outcomes during the open label extension in this underserved patient population.”.

我们对各研究中心顺利启动给药感到鼓舞，并期待评估其对小胶质细胞活化的影响，进而在此未获充分医疗服务的患者人群的开放标签扩展阶段中进一步评估临床结局。

“We are thrilled to reach this important milestone in our Phase 2 program,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “The successful initiation of dosing in all patients underscores the strong execution by our clinical teams and the enthusiasm from investigators and patients for this novel intranasal approach.

“我们很高兴在二期临床试验项目中达到这一重要里程碑，”Tiziana Life Sciences 首席执行官 Ivor Elrifi 表示。“所有患者成功开始给药，凸显了我们临床团队的强大执行力，以及研究者和患者对这种新型鼻内给药途径的热情。”

We are especially grateful for the unwavering contributions of Principal Investigator Dr. Tanuja Chitnis, whose expertise and dedication have been instrumental in advancing this trial..

我们特别感谢首席研究员Tanuja Chitnis博士的坚定贡献，她的专业知识和奉献精神对推动本试验的进展起到了关键作用。

Intranasal foralumab has the potential to modulate the immune system in a targeted manner with a favorable safety profile, offering new hope for patients with na-SPMS, a condition with limited treatment options.”

鼻用foralumab有望以靶向方式调节免疫系统，且安全性良好，为治疗选择有限的非活动性继发进展型多发性硬化症（na-SPMS）患者带来了新希望。

Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development delivered intranasally. This innovative route of administration aims to provide improved efficacy, safety, and tolerability compared to traditional intravenous delivery by targeting immune modulation directly in the nasal passages, with potential effects on the central nervous system..

Foralumab 是目前临床开发中唯一一种通过鼻内给药的全人源抗 CD3 单克隆抗体。这种创新的给药途径旨在通过在鼻腔内直接靶向免疫调节，并对中枢神经系统产生潜在影响，从而与传统静脉给药相比提供更优的疗效、安全性和耐受性。

The Company will continue monitoring patients through the 12-week treatment period and open-label extension, with topline data anticipated in the coming months.

本公司将在12周的治疗期及开放标签扩展阶段持续监测患者，预计在未来几个月内获得初步数据。

About Foralumab

关于福拉鲁单抗

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，作为一种生物制剂候选药物，已被证明在鼻内给药时能够刺激调节性T细胞。目前，在一项中等规模的开放标签扩展访问（EA）计划中，已有14名非活动性继发进展型多发性硬化症（na-SPMS）患者接受了给药。

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个月内均观察到疾病改善或稳定。此外，鼻用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IIa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）。鼻内给予 foralumab 进行免疫调节，为治疗人类神经炎症和神经退行性疾病开辟了一条新途径。

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About Tiziana Life Sciences

关于蒂齐亚纳生命科学公司

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 是一家处于临床阶段的生物制药公司，致力于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给药途径。与静脉注射（IV）相比，Tiziana 创新的鼻内给药方法有望在疗效、安全性和耐受性方面带来改善。

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 的主要候选药物鼻用 foralumab 是目前临床开发中唯一的全人源抗 CD3 单克隆抗体，在迄今的研究中已显示出良好的安全性和临床反应。Tiziana 的替代免疫治疗给药技术已获得专利，多项申请正在审理中，预计将支持其广泛的管线应用。

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

欲了解更多关于 Tiziana 及其创新疗法管线的信息，请访问

www.tizianalifesciences.com

。

Forward-Looking Statements

前瞻性陈述

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.

本公告中的某些陈述属于前瞻性陈述。这些前瞻性陈述并非历史事实，而是基于Tiziana对其行业、信念和假设的当前预期、估计和预测。诸如“预计”、“期望”、“打算”、“计划”、“相信”、“寻求”、“估计”及类似表述旨在识别前瞻性陈述。

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.

这些陈述并不保证未来的表现，并且受到已知和未知风险、不确定性以及其他因素的影响，其中一些因素超出了Tiziana的控制范围，难以预测，并可能导致实际结果与前瞻性陈述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 提醒证券持有人及潜在证券持有人，切勿过度依赖这些前瞻性陈述，因其仅反映 Tiziana 在本公告发布之日的观点。由于各种重要因素，实际结果可能与该等前瞻性陈述所指示的结果存在重大差异，这些因素包括：与市场状况相关的不确定性，以及在 Tiziana 截至 2025 年 12 月 31 日年度的 20-F 表格年度报告中“风险因素”章节更全面描述的其他因素，以及向美国证券交易委员会提交的其他定期报告中所述的因素。

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.

本公告中所作的前瞻性陈述仅涉及陈述作出之日的事件。除法律或任何规定要求外，Tiziana 不承担公开释放对这些前瞻性陈述的任何修订或更新以反映本公告日期后发生的事件、情况或意外事件的义务。

For further inquiries:

如有进一步咨询：

Tiziana Life Sciences Ltd

提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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