A Phase 2a Randomized, Double-Blind Study to Evaluate the Safety, Biomarker Activity, and Microglial Activation of Nasal Foralumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

The goal of this clinical trial is to learn whether a nasal spray medicine called foralumab is safe and easy to tolerate in adults with amyotrophic lateral sclerosis (ALS). ALS is a disease that slowly damages the nerve cells that control movement, causing muscles to grow weaker over time. Foralumab is being studied as a possible way to calm the inflammation and immune system activity that are thought to play a role in ALS.
The main questions it aims to answer are:
1. Is nasal foralumab safe for people with ALS, and how well do they tolerate it over 12 and 24 weeks of treatment?
2. Does foralumab change certain markers in the blood and spinal fluid, and lower inflammation in the brain, compared with a placebo?
Researchers will compare people who take foralumab to people who take a placebo (a matching nasal spray with no medicine in it) to see how the two groups differ in safety and in these markers.
About 44 adults aged 18 to 75 with ALS will take part. For the first 12 weeks, participants will be randomly assigned so that about 3 in 4 use foralumab and about 1 in 4 use the placebo. Neither the participants nor the study staff will know who is using which during this time (this is called "double-blind"). After the first 12 weeks, everyone who continues will use foralumab for the next 12 weeks.
Participants will:
* Spray the study treatment into both nostrils 3 times a week, on alternate days, in cycles of 2 weeks on treatment followed by 1 week off
* Learn to use the nasal spray device so they or a caregiver can give most doses at home
* Take part for about 8.5 months in total, which includes screening, 24 weeks of treatment, and a safety check-in about 4 weeks after the last dose
* Attend some visits at the study clinic and complete others remotely by phone or video
* Have study tests that may include blood samples, breathing and muscle-strength checks, and - for those who agree and at certain study centers - spinal fluid samples and brain scans to measure inflammation

开始日期2026-07-25

申办/合作机构

Tiziana Life Sciences Ltd. (Bermuda)

NCT06489548

/ Recruiting临床2期IIT

Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimer's Disease

This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.
The trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.

开始日期2025-09-16

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT06868628

/ Recruiting临床2期

A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)

开始日期2025-05-19

申办/合作机构

Tiziana Life Sciences Ltd. (Bermuda)

100 项与 Foralumab 相关的临床结果

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100 项与 Foralumab 相关的转化医学

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100 项与 Foralumab 相关的专利（医药）

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项与 Foralumab 相关的文献（医药）

2025-08-01·CLINICAL NUCLEAR MEDICINE

Dampening of Microglial Activation With Nasal Foralumab Administration in Moderate Alzheimer’s Disease Dementia

Article

作者: Singhal, Tarun ; Cicero, Steven ; Gale, Seth A. ; Horan, Nicolas ; Weiner, Howard L. ; Dubey, Shipra ; Marshall, Gad A.

A 78-year-old man with moderate Alzheimer disease (AD) dementia was treated with nasal-foralumab, a fully human anti-CD3 monoclonal antibody, as part of a Food and Drug Administration expanded-access-program, based on previously demonstrated efficacy of anti-CD3 antibody in animal models. 18F-PBR06-PET, utilizing a second-generation 18-kDa-translocator-protein ligand targeting microglia, showed diffuse reduction of radiotracer uptake throughout the brain, following 3 months of nasal-foralumab compared with baseline. In particular, precuneus, posterior cingulate and anterior cingulate gyri, regions that had high levels of amyloid deposition on a baseline 18F-Florbetapir-PET scan, showed reduction in microglial activation after nasal-foralumab treatment for 3 months.

2023-03-14·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Nasal administration of anti-CD3 mAb (Foralumab) downregulates NKG7 and increases TGFB1 and GIMAP7 expression in T cells in subjects with COVID-19

1区 · 综合性期刊

Article

作者: G. Moreira, Thais ; Mangani, Davide ; Healy, Brian C. ; Gauthier, Christian D. ; Murphy, Liam ; Paul, Anu ; Izzy, Saef ; Lanser, Toby B. ; Kuchroo, Vijay ; Rezende, Rafael M. ; Weiner, Howard L. ; Baecher-Allan, Clare M. ; Chitnis, Tanuja ; Matos, Kimble T. F.

T cells are present in early stages of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and play a major role in disease outcome and long-lasting immunity. Nasal administration of a fully human anti-CD3 monoclonal antibody (Foralumab) reduced lung inflammation as well as serum IL-6 and C-reactive protein in moderate cases of COVID-19. Using serum proteomics and RNA-sequencing, we investigated the immune changes in patients treated with nasal Foralumab. In a randomized trial, mild to moderate COVID-19 outpatients received nasal Foralumab (100 μg/d) given for 10 consecutive days and were compared to patients that did not receive Foralumab. We found that naïve-like T cells were increased in Foralumab-treated subjects and NGK7 + effector T cells were reduced. CCL5,IL32,CST7,GZMH,GZMB,GZMA,PRF1 , and CCL4 gene expression were downregulated in T cells and CASP1 was downregulated in T cells, monocytes, and B cells in subjects treated with Foralumab. In addition to the downregulation of effector features, an increase in TGFB1 gene expression in cell types with known effector function was observed in Foralumab-treated subjects. We also found increased expression of GTP-binding gene GIMAP7 in subjects treated with Foralumab. Rho/ROCK1, a downstream pathway of GTPases signaling was downregulated in Foralumab-treated individuals. TGFB1,GIMAP7 , and NKG7 transcriptomic changes observed in Foralumab-treated COVID-19 subjects were also observed in healthy volunteers, MS subjects, and mice treated with nasal anti-CD3. Our findings demonstrate that nasal Foralumab modulates the inflammatory response in COVID-19 and provides a novel avenue to treat the disease.

2022-02-28·Journal of acupuncture and meridian studies

Injection Effect of Anti-CD3 Monoclonal Antibody on Primo Vessel in Lymph Vessel of Rabbit with Lipopolysaccharide-Induced Inflammation

Article

作者: Lee, Sang-Suk ; Choi, Jong-Gu ; Choi, Sang-Heon

Background:

The primo vascular system can be viewed as a circulatory system that plays a therapeutic function in regenerating the body tissue. The anti-CD3 monoclonal antibody was used as an immunotherapeutic agent to treat the novel coronavirus infection (COVID-19). Objectives: In this study, we observed the effect of injecting lymph nodes with Foralumab, an anti- human CD3 epsilon therapeutic monoclonal antibody, on primo vessels.

Methods:

The structure and atomic stoichiometry of the antibody were determined by transmission electron microscopy and energy dispersive spectroscopy. Alcian blue dying solution was injected into the lymph nodes of the abdominal vena cava of rabbits, and the solution further flowed into the lymph vessels.

Results:

A primo vessel with primo nodes stained with Alcian blue was clearly visible in the lymph vessel. By injecting Foralumab into lymph nodes of rabbits with lipopolysaccharide-induced inflammation, the floating primo vessel in the lymph vessel appeared thicker and was distinctly visible.

Conclusion:

The observation of the primo vessel post-treated with Foralumab in the inflamed lymphatic system suggests the possibility of a functional role of the primo vascular circulatory system in pathophysiological conditions.

215

项与 Foralumab 相关的新闻（医药）

2026-06-26

·泓博医药人工智能药物设计平台

今日生物医药快讯-2026.06.25

本期快讯摘要临床方面，Cognition Therapeutics 与 FDA 达成关键共识推动 Zervimesine 针对 DLB 幻觉和妄想的 III 期临床试验，Corxel Pharmaceuticals 口服 GLP-1 受体激动剂 CX-11 体重管理 II 期试验达成主要终点；公司动态方面，Antares 与诺华达成 19 亿美元合作聚焦不可成药靶点小分子开发，礼来与 Abbisko 签署 19 亿美元发现协议布局多靶点创新药。本文多维度解读全球生物医药产业新变化，助力读者高效洞察行业趋势。 01 专题板块临床试验 6 条 01Cognition Therapeutics 与 FDA 达成关键共识，推动 Zervimesine 针对 DLB 幻觉和妄想的 III 期临床试验 Cognition Therapeutics 宣布已与 FDA 达成关键共识，确认其候选药物 Zervimesine（CT1812）在治疗路易体痴呆（DLB）相关精神病症状（如幻觉和妄想）方面具有潜在的注册性终点价值。该 III 期临床试验计划于 2027 年中启动，采用每日一次口服 100mg Zervimesine 与安慰剂进行为期九个月的随机对照研究，主要终点为神经精神量表（NPI）评估的 DLB 幻觉和妄想症状进展。此前的 II 期 SHIMMER 试验显示，Zervimesine 可使 DLB 幻觉和妄想症状的进展减缓 89%。DLB 是一种进展性神经退行性疾病，高达 80% 的患者会出现精神病症状，但目前尚无 FDA 批准的治疗药物，现有方案多依赖于未经批准的抗精神病药物，存在较大安全风险。此次与 FDA 的共识为 Zervimesine 进入注册性试验提供了明确路径，具有显著的临床和商业价值。 Cognition TherapeuticsZervimesineDLBNPI 02Wave Life Sciences启动WVE-007 IIa期多剂量试验，探索siRNA疗法在肥胖及代谢疾病中的潜力 Wave Life Sciences宣布启动其WVE-007（INHBE GalNAc-siRNA）在肥胖和代谢疾病中的IIa期多剂量试验。此前的I期单剂量试验数据显示，单次240 mg剂量在6个月随访中可实现14%的内脏脂肪减少（p<0.05），同时保持肌肉质量，支持其每年一次或两次的潜在给药频率。IIa期试验将招募BMI较高（35-50 kg/m²）且伴有代谢并发症的患者，评估体重、腰围、体成分（MRI和DEXA）、肝脂肪（MRI-PDFF）、HbA1c和血脂水平等指标，进一步验证WVE-007在肥胖、MASH、2型糖尿病和心血管疾病中的治疗潜力。该药物基于Wave的Stereopure干扰核酸（SpiNA）平台设计，通过沉默INHBE基因，实现靶向脂解作用。在动物模型中，与semaglutide联用可使体重减轻翻倍并防止体重反弹。此试验进展为RNAi疗法在肥胖领域的应用提供了重要临床依据。 Wave Life SciencesWVE-007siRNAINHBE 03Corxel Pharmaceuticals口服GLP-1受体激动剂CX-11 II期临床试验达成主要终点 Corxel Pharmaceuticals Ltd.宣布其口服小分子GLP-1受体激动剂CX-11在针对肥胖和超重患者的II期临床试验中达到了主要终点。该试验在美国开展，初步结果显示该药物在体重管理方面具有良好的临床潜力。GLP-1受体激动剂近年来在代谢类疾病治疗中受到广泛关注，尤其是其在肥胖和糖尿病领域的应用。CX-11作为一款口服制剂，若后续临床试验顺利推进，有望为患者提供更便捷的治疗选择，并为Corxel带来显著的商业价值。此次II期试验的成功，标志着该公司在小分子GLP-1药物开发领域迈出了关键一步。 Corxel PharmaceuticalsGLP-1CX-11肥胖 04Kymera完成KT-621治疗特应性皮炎的IIb期BROADEN2试验入组，预计2026年底发布关键数据 Kymera Therapeutics宣布已提前近六个月完成其全球IIb期BROADEN2试验的患者入组，该试验评估其首创的口服STAT6降解剂KT-621在中重度特应性皮炎（AD）患者中的疗效和安全性。BROADEN2是一项随机、双盲、安慰剂对照、剂量探索研究，共纳入约200名12至75岁的AD患者，主要终点为第16周Eczema Area and Severity Index (EASI)评分较基线的变化百分比。次要终点包括安全性、疗效和生活质量指标。KT-621此前已在I期临床中显示出在血液和皮肤中深度降解STAT6的能力，并显著降低与AD相关的2型炎症生物标志物，同时表现出良好的安全性和耐受性。该药物已获得FDA的快速通道认定，用于治疗AD和嗜酸性粒细胞性哮喘。Kymera计划在2026年底公布BROADEN2的初步数据，并在与监管机构讨论后于2027年中启动III期试验。 Kymera TherapeuticsKT-621STAT6特应性皮炎 05AnaCardio公布AC01治疗HFrEF的1b/2a期试验数据，显示心脏功能改善且安全性良好 AnaCardio近日在《The Lancet》上发表了其1b/2a期临床试验GOAL-HF1的结果，评估了首个口服钙敏化收缩剂AC01在射血分数降低型心力衰竭（HFrEF）患者中的安全性和初步疗效。试验共纳入58名患者，结果显示AC01具有良好的安全性和耐受性，未出现与药物相关的严重不良事件、死亡或因不良反应停药的情况。在心脏功能方面，AC01在第1天即显示出心脏输出量和每搏输出量的快速改善，并在第28天持续存在。此外，3 mg剂量组患者的左心室射血分数平均提高4.8个百分点，显著优于安慰剂组的1.6个百分点。该试验为AC01进入2b期临床试验提供了坚实基础，也标志着其作为首个口服钙敏化剂在心衰治疗领域的潜在突破。AC01的独特机制与良好安全性，有望改变当前心衰治疗中缺乏有效口服药物的现状。 AnaCardioAC01HFrEF钙敏化剂 06Tiziana完成INFORM-MS II期临床试验首例患者给药 Tiziana Life Sciences宣布其II期临床试验INFORM-MS已成功完成所有48例非活动性继发进展型多发性硬化症（na-SPMS）患者的首剂量给药。该试验为随机、双盲、安慰剂对照研究，旨在评估两种剂量的鼻腔给药型Foralumab（一种全人源抗CD3单克隆抗体）的安全性、耐受性及疗效。主要终点为通过正电子发射断层扫描（PET）测量的微胶质细胞激活变化，次要终点包括扩展残疾状态量表（EDSS）、生活质量评估和改良疲劳影响量表（MFIS）。此前，Foralumab在一项开放标签扩展访问计划中已显示出良好的安全性和疾病稳定或改善的初步临床效果。鼻腔给药方式被认为是传统静脉注射之外的一种创新免疫调节途径，具有潜在的疗效与安全性优势。该试验的顶线数据预计于2026年第三季度末至第四季度初公布，并计划在2026年10月于加拿大多伦多举行的ACTRIMS-ECTRIMS联合会议上展示。 TizianaForalumab抗CD3单抗鼻腔给药 02 专题板块公司动态 3 条 01Antares 与诺华达成19亿美元合作，聚焦不可成药靶点的小分子开发 Antares Therapeutics 与诺华达成一项潜在价值19亿美元的合作协议，旨在发现针对肿瘤学中不可成药靶点的小分子药物。此次合作包括1.05亿美元的预付款，是Antares自一年前从Scorpion Therapeutics分拆以来的首次重要合作伙伴关系。诺华作为全球领先的制药企业，其参与表明对Antares在小分子药物研发平台上的认可，特别是在攻克传统意义上不可成药靶点方面的潜力。该合作不仅为Antares提供了重要的资金支持，也为其后续研发和商业化奠定了基础。对于行业而言，这标志着针对“不可成药”靶点的小分子药物开发正在成为主流药企关注的重点领域，可能推动相关靶点药物的BD合作与研发外包需求增长。 Antares TherapeuticsNovartis小分子不可成药靶点 02礼来与Abbisko达成19亿美元发现合作，布局多靶点创新药研发礼来公司与Abbisko Therapeutics Co. Ltd.签署了一项总额达19亿美元的研究合作与授权协议，旨在共同发现和开发针对多个靶点的创新药物。此次合作聚焦于推进具有全球潜力的候选药物研发，是礼来在小分子药物发现领域的重要战略布局。通过引入Abbisko的发现平台和靶点资源，礼来有望加速其管线扩展，增强在创新疗法领域的竞争力。该交易体现了跨国药企对前沿药物发现技术的持续关注，也反映了行业对多靶点药物研发的重视程度不断提升。此类合作通常对CRO/CDMO产业格局和BD活动具有显著影响。礼来Abbisko药物发现多靶点 03Remix Therapeutics 与 Passage Bio 达成合并协议，推进新型小分子RNA调控疗法 Remix Therapeutics 与 Passage Bio 宣布达成一项全股票合并协议，合并后公司将继续以 Remix Therapeutics 为名运营，并计划在纳斯达克以 RMTX 为代码上市。此次合并将整合双方资源，加速推进 Remix 的临床管线，特别是其核心候选药物 REM-422 的开发。REM-422 是一款口服型 mRNA 降解剂，靶向 MYB 转录因子，该因子在多种癌症中具有重要作用。目前，REM-422 正在腺样囊性癌（ACC）和急性髓系白血病（AML）或高危骨髓增生异常综合征（HR-MDS）中进行注册性 II 期临床试验，并已获得 FDA 颁发的孤儿药认定和 ACC 适应症的快速通道认定。合并同时伴随一项超额认购的 1 亿美元私募融资，由 Decheng Capital 领投，预计可支持公司运营至 2028 年，并推动多个关键临床数据的披露。 Remix TherapeuticsREM-422mRNA degraderMYB

2026-06-25

·Innodrugs

Tiziana 宣布其二期临床试验 INFORM-MS 完成最后一例受试者给药

马萨诸塞州波士顿，2026年6月25日——Tiziana Life Sciences, Ltd.（纳斯达克代码：TLSA，下称“Tiziana”）是一家生物科技企业，核心候选药物为鼻腔给药foralumab，一款全人源抗CD3单克隆抗体。公司今日宣布，评估鼻腔foralumab用于治疗非活动性继发进展型多发性硬化症（na-SPMS）的IIa期临床试验已完成最后一例受试者首次给药。核心顶线数据预计将于2026年第三季度末至第四季度初出炉，并计划于2026年10月在加拿大多伦多举办的第十届美洲多发性硬化症治疗与研究委员会与ECTRIMS联合大会上公布。这项随机、双盲、安慰剂对照IIa期临床试验名为INFORM-MS（NCT06292923），计划纳入最多48名na-SPMS患者，对比两种剂量鼻腔foralumab与安慰剂的安全性、耐受性及疗效。该研究在美国多家试验中心开展，同步评估影像学生物标志物与临床终点指标。美国多家顶尖临床中心正在完成全部受试者给药工作，合作机构包括布莱根妇女医院、约翰·霍普金斯大学、威尔康奈尔医学院、耶鲁多发性硬化症中心等。试验主要终点为正电子发射断层扫描（PET）检测的小胶质细胞活化水平变化，次要临床评估指标包含扩展残疾状态量表（EDSS）、生活质量评分、改良疲劳影响量表（MFIS）。麻省总医院布莱根神经科学研究所资深神经科医师、本试验主要研究者Tanuja Chitnis医学博士表示：“能够担任INFORM-MS试验主要研究者，我深感荣幸。鼻腔foralumab为非活动性继发进展型多发性硬化症患者带来极具前景的创新治疗方案。各中心给药工作推进顺畅令我们备受鼓舞，我们期待评估该药物对小胶质细胞活化的改善作用，并在开放标签延展试验中进一步观察其临床疗效，惠及这类缺少有效治疗手段的患者群体。” Tiziana Life Sciences首席执行官Ivor Elrifi表示：“我们十分欣喜II期项目达成这一关键里程碑。全部受试者顺利完成首次给药，印证了临床团队高效的执行能力，也体现出研究者与患者对这款全新鼻腔给药疗法的高度认可。特别感谢主要研究者Tanuja Chitnis博士始终倾力投入，她的专业与付出为本试验的推进起到关键作用。鼻腔foralumab可实现靶向免疫调节，且安全性表现良好，为治疗选择有限的na-SPMS患者带来新的治疗希望。” foralumab是目前临床开发阶段唯一一款鼻腔给药全人源抗CD3单克隆抗体。这种创新给药方式直接在鼻腔局部调节免疫，相比传统静脉输注有望提升疗效、安全性与耐受性，并可作用于中枢神经系统。公司将持续随访受试者，完成12周给药周期及开放标签延展期观察，预计数月后公布核心顶线数据。关于foralumab foralumab为全人源抗CD3单克隆抗体生物候选药物，鼻腔给药可刺激调节性T细胞增殖。一项中等规模开放标签扩大准入项目（NCT06802328）已纳入14名na-SPMS患者使用鼻腔foralumab，所有受试者在6个月内均出现病情改善或稳定。此外，一项针对非活动性继发进展型多发性硬化症的随机、双盲、安慰剂对照、多中心、剂量探索IIa期临床试验（NCT06292923）正在开展鼻腔foralumab相关研究。 foralumab是当前唯一处于临床开发阶段的全人源抗CD3单克隆抗体。鼻腔foralumab介导的免疫调节，为神经炎症及神经退行性疾病开辟了全新治疗路径。关于Tiziana Life Sciences Tiziana是一家临床阶段生物制药企业，依托革新性给药技术开发创新疗法，探索免疫治疗的非静脉给药途径。相较于静脉输注，公司独创鼻腔给药方案有望同步提升药物疗效、安全性与耐受性。核心候选药物鼻腔foralumab是目前唯一处于临床阶段的全人源抗CD3单克隆抗体，现有各项研究均显示其安全谱良好，且可在患者体内产生临床获益。公司免疫治疗非静脉给药技术已获得专利授权，多项相关专利申请正在审核中，未来可广泛应用于多条研发管线。如需了解Tiziana及其创新治疗管线更多详情，敬请访问官网www.tizianalifesciences.com。免责声明：所载内容来源互联网，仅供参考。转载稿件版权归原作者和机构所有，如有侵权，请联系我们删除。

2026-06-25

·动脉网

Tiziana宣布其II期INFORM-MS试验中最后一名患者成功给药Tiziana Announces Last Patient Successfully Dosed in its Phase 2 INFORM-MS trial

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 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 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 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 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。[1],[2],[3] [1],[2],[3]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 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 +44 (0) 207 495 2379email: 电子邮件：info@tizianalifesciences.com info@tizianalifesciences.com[1] [1]https://www.pnas.org/doi/10.1073/pnas.2220272120 https://www.pnas.org/doi/10.1073/pnas.2220272120[2] [2]https://www.pnas.org/doi/10.1073/pnas.2309221120 https://www.pnas.org/doi/10.1073/pnas.2309221120[3] [3]https://www.neurology.org/doi/10.1212/NXI.0000000000200543 https://www.neurology.org/doi/10.1212/NXI.0000000000200543

100 项与 Foralumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Foralumab	-	DB16170

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肌萎缩侧索硬化	临床2期	-	Tiziana Life Sciences Ltd. (Bermuda)	2026-07-25
阿尔茨海默症	临床2期	美国	Tiziana Life Sciences Ltd. (Bermuda)	2025-09-16
多系统萎缩	临床2期	美国	Tiziana Life Sciences Ltd. (Bermuda)	2025-05-19
继发进展型多发性硬化	临床2期	美国	Tiziana Life Sciences Ltd. (Bermuda)	2023-11-15
多发性硬化症	临床2期	英国	Tiziana Life Sciences Ltd. (Bermuda)	2023-04-27
新型冠状病毒感染	临床2期	-	Tiziana Life Sciences Ltd. (Bermuda)	2022-04-30
2型糖尿病	临床2期	-	Tiziana Life Sciences Ltd. (Bermuda)	2017-12-01
代谢功能障碍相关脂肪性肝炎	临床2期	-	Tiziana Life Sciences Ltd. (Bermuda)	2017-12-01
1型糖尿病	临床2期	奥地利	NovImmune SA	2009-10-13
急性细胞移植排斥反应	临床2期	法国	NovImmune SA	2007-11-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06489548 (Company_Website 1 \| Company_Website 2) 人工标引	临床2期	阿尔茨海默症	1	intranasal foralumab	鬱選餘築壓網構窪蓋餘(製鬱網衊鹹選構艱餘積) = showing a marked reduction in microglia activation 蓋鑰製憲齋淵糧膚壓鬱 (築觸餘廠遞蓋網鏇製遞 )	积极	2025-05-09
NCT06802328 (GlobeNewswire) 人工标引	N/A	继发进展型多发性硬化	10	Foralumab	觸壓淵網齋顧網憲糧願(餘餘艱繭願膚鹹選壓網) = None 艱醖衊願艱範積夢顧蓋 (製遞鹽鹹憲築獵繭醖鬱 ) 更多	积极	2025-05-06
GlobeNewswire 人工标引	N/A	继发进展型多发性硬化	-	Foralumab	衊淵構夢網鑰簾鹹繭壓(構網齋遞構齋網膚艱網) = 窪膚鬱鏇繭糧蓋壓窪獵醖蓋鹹衊簾鏇鑰簾廠醖 (網壓願製衊糧鬱襯範淵 )	积极	2024-06-06
GlobeNewswire 人工标引	N/A	继发进展型多发性硬化	6	foralumab	選蓋醖鑰餘築膚鬱獵鬱(壓鬱壓廠鹽襯蓋願膚鬱) = 顧鑰遞襯遞範簾餘顧衊淵鑰鏇齋範糧製糧網繭 (窪膚醖憲構膚積簾艱觸 ) 更多	积极	2024-04-25
GlobeNewswire 人工标引	临床2期	多发性硬化症	10	Foralumab	憲觸淵襯鬱鹹醖簾範簾(製選襯築網醖繭夢繭遞) = six out of eight Intermediate Size Patient Population Expanded Access (EA) patients have shown improvements in fatigue scores. PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period. 築憲淵顧衊糧窪顧窪廠 (廠蓋廠積壓襯積遞齋淵 )	积极	2024-01-08
NCT05029609 (Corporate Publications) 人工标引	临床1期	继发进展型多发性硬化	2	Foralumab	醖積醖鹹衊獵鬱窪襯鑰(糧夢積構餘繭廠膚觸襯) = The patient showed clinically significant improvement on the Extended Disability Status Scale (EDSS) 憲蓋鹽構鹹衊廠醖憲顧 (窪網衊醖糧淵構製築顧 )	积极	2022-09-20