预约演示
更新于：2025-01-23
Temelimab (GeNeuro)
更新于：2025-01-23
概要
基本信息
药物类型 单克隆抗体 |
别名 Anti-HERV-W humanized monoclonal antibodies(GeNeuro)、Immunoglobulin G4, anti-(multiple sclerosis-associated retrovirus viral envelope protein) (human-mus musculus monoclonal gnbac1 heavy chain), disulfide with human-mus musculus monoclonal gnbac1 kappa-chain, dimer、Temelimab + [5] |
靶点 |
作用机制 ERV env inhibitors(ERV包膜基因抑制剂) |
原研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 1297997H
来源: *****
Sequence Code 1298001L
来源: *****
关联
10
项与 Temelimab (GeNeuro) 相关的临床试验NCT05497089
Temelimab as a Disease Modifying Therapy in Patients With Neurological, Neuropsychological, and Psychiatric (=Neuropsychiatric) Symptoms in Post-COVID 19 or Postacute Sequelae of COVID-19 (PASC) Syndrome
This study is a Phase 2, 24-week, randomized, prospective, double-blind, multicenter study in patients experiencing neuropsychiatric symptoms and functional impairment in the course of PASC. The purpose of the study is to evaluate the efficacy and safety of Temelimab as a treatment for PASC neuropsychiatric symptoms in patients who had severe acute respiratory syndrome coronavirus - type 2 (SARS-CoV-2) infection but did not undergo intensive care treatment during the acute period. Patients meeting eligibility criteria will be randomized to Temelimab or placebo in a 1:1 ratio via interactive voice/web response system to obtain 182 protocol completers. The randomization will be stratified by age (≤65 years versus >65 years).
开始日期2022-08-29 |
申办/合作机构 |
NCT05049161
A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With Rituximab
This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab. The patients of the placebo group in study GNC-401 will be re-randomized to temelimab 18 mg/kg, 36 mg/kg or 54 mg/kg (1:1:1), while the patients who received temelimab in study GNC-401 will continue with the same dose in study GNC-402. Following final analysis of the results of the GNC-401 study, the Sponsor may switch all patients to an optimal dose of temelimab based on safety and efficacy demonstrated in the GNC-401 study.
开始日期2021-08-27 |
申办/合作机构 |
NCT04480307
A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)
Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).
In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.
In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.
开始日期2020-06-17 |
申办/合作机构 |
100 项与 Temelimab (GeNeuro) 相关的临床结果
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100 项与 Temelimab (GeNeuro) 相关的转化医学
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100 项与 Temelimab (GeNeuro) 相关的专利（医药）
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24
项与 Temelimab (GeNeuro) 相关的文献（医药）2023-06-29·Journal of virology
CancerHERVdb: Human Endogenous Retrovirus (HERV) Expression Database for Human Cancer Accelerates Studies of the Retrovirome and Predictions for HERV-Based Therapies.
Article
作者: Peckham-Gregory, Erin C ; Stricker, Erik ; Scheurer, Michael E
2023-06-25·World journal of virology
Etiopathogenic theories about long COVID.
Review
作者: Del Carpio-Orantes, Luis
2022-08-01·Multiple Sclerosis and Related Disorders
Temelimab for MS and SARS-CoV-2: Could it be a double-edged blessing?
Letter
作者: Mouliou, Dimitra S ; Dardiotis, Efthimios
6
项与 Temelimab (GeNeuro) 相关的新闻（医药）2024-11-13
Multiple sclerosis (MS) is a chronic neurological disorder affecting the central nervous system (CNS), particularly the brain, spinal cord, and optic nerves. Continuous research has led to new drug developments, particularly disease-modifying therapies (DMTs) that slow MS progression. Monoclonal antibodies, oral therapies, and infusion treatments are among the most promising options and drives the multiple sclerosis market.
LAS VEGAS, Nov. 13, 2024 /PRNewswire/ -- DelveInsight's
'
Multiple Sclerosis Pipeline Insight 2024
' report provides comprehensive global coverage of pipeline multiple sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the multiple sclerosis pipeline domain.
Key Takeaways from the Multiple Sclerosis Pipeline Report
DelveInsight's multiple sclerosis pipeline report depicts a robust space with
75+ active players working to develop
80+ pipeline therapies for multiple sclerosis treatment.
Key multiple sclerosis companies such as
Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape.
Promising multiple sclerosis pipeline therapies such as
GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials.
In
October 2024, Immunic, Inc. reported favorable results from the non-binding interim futility analysis of its Phase 3 ENSURE trial, which is evaluating its lead candidate, vidofludimus calcium (IMU-838), a nuclear receptor-related 1 (Nurr1) activator, for the treatment of relapsing multiple sclerosis (RMS).
In October 2024, Immunic, Inc. announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.
In
September 2024, Roche, secured FDA approval for an injectable form of its blockbuster multiple sclerosis treatment, Ocrevus, reducing patient treatment time and potentially helping the company stay ahead of increasing competition.
In
September 2024, Sanofi announced the outcomes of Phase III clinical trials of its investigational oral brain-penetrant BTK inhibitor, tolebrutinib, aimed at treating multiple sclerosis (MS). These studies, namely HERCULES, GEMINI 1, and GEMINI 2, have provided mixed results, with the HERCULES trial meeting its primary endpoint while the GEMINI trials did not. The HERCULES study focused on the efficacy and safety of tolebrutinib in individuals with non-relapsing secondary progressive MS (nrSPMS) compared to a placebo.
In
August 2024, Abata Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101's Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase I study is imminent.
In
August 2024, TG Therapeutics announced that the FDA has cleared an investigational new drug (IND) application submitted by TG Therapeutics for azercabtagene zapreleucel (azer-cel), an investigational allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, for a phase 1 clinical trial in patients with progressive multiple sclerosis (MS).
In
January 2024, Kyverna Therapeutics, Inc. announced it received fast-track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of multiple sclerosis (MS).
Request a sample and discover the recent advances in multiple sclerosis treatment drugs @
Multiple Sclerosis Pipeline Report
The multiple sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage multiple sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the multiple sclerosis clinical trial landscape.
Multiple Sclerosis Overview
Multiple sclerosis is a chronic autoimmune disorder that affects the central nervous system, leading to the deterioration or permanent damage of myelin, the protective sheath surrounding nerve fibers. While the exact cause of multiple sclerosis remains unclear, it is believed to involve a combination of genetic predisposition, environmental factors, and possibly viral infections. Common symptoms of multiple sclerosis include fatigue, difficulty walking, numbness or tingling in the limbs, muscle weakness, and vision problems, which can vary significantly among individuals and may evolve over time.
Diagnosis typically involves a combination of neurological examinations, magnetic resonance imaging (MRI) to detect lesions in the brain and spinal cord, and sometimes lumbar puncture to analyze cerebrospinal fluid for inflammatory markers. While there is no cure for multiple sclerosis, treatment options aim to manage symptoms, reduce the frequency and severity of relapses, and slow disease progression. This may include disease-modifying therapies (DMTs), corticosteroids for acute exacerbations, and symptomatic treatments such as physical therapy, pain management, and lifestyle modifications. Early diagnosis and a tailored treatment plan are crucial for improving the quality of life for those living with multiple sclerosis.
Find out more about multiple sclerosis treatment drugs @
Drugs for
Multiple Sclerosis Treatment
A snapshot of the Multiple Sclerosis Pipeline Drugs mentioned in the report:
Learn more about the emerging multiple sclerosis pipeline therapies @
Multiple Sclerosis Clinical Trials
Multiple Sclerosis Therapeutics Assessment
The multiple sclerosis pipeline report proffers an integral view of the multiple sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Multiple Sclerosis Pipeline Report
Coverage: Global
Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Therapeutics Assessment
By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
Therapeutics Assessment
By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
Therapeutics Assessment
By Mechanism of Action: Immunomodulators, MHC class II gene modulators, Agammaglobulinaemia tyrosine kinase inhibitors, Dihydroorotate dehydrogenase inhibitors, Nuclear receptor subfamily 4 group A member 2 agonists, CD20 antigen inhibitors, Energy metabolism stimulants; Immunomodulators, Lysine-specific demethylase 1 inhibitors, Monoamine oxidase B inhibitors, Protein-arginine deiminase inhibitors, Immunostimulants
Key Multiple Sclerosis Companies: Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape.
Key Multiple Sclerosis Pipeline Therapies:GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials.
Dive deep into rich insights for new drugs for multiple sclerosis treatment, visit @
Multiple Sclerosis Drugs
Table of Contents
For further information on the multiple sclerosis pipeline therapeutics, reach out @
Multiple Sclerosis Treatment Drugs
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临床3期临床结果快速通道细胞疗法免疫疗法
2024-06-28
GeNeuro joins a list of companies that have swung at long COVID and missed.
GeNeuro reported (PDF) the near-total failure of its phase 2 long COVID trial Friday, telling investors it saw no effect on the primary endpoint and most secondary goals. The Swiss biotech responded by laying off staff and seeking strategic alternatives.
Geneva-based GeNeuro began testing the anti-HERV-W-Env antibody temelimab, also called GNC-501, in long COVID after seeing evidence immune dysregulation drives the post-infection symptoms. One study found the W-ENV protein on lymphocytes in people hospitalized with COVID-19. If expression continued after infection, the protein could damage cells and cause long-term neurological symptoms.
GeNeuro enrolled 203 people with long COVID at sites in Switzerland, Spain and Italy in the phase 2. All subjects tested positive at the start of the study for HERV-W-Env, the protein targeted by temelimab and the potential driver of long COVID’s neurological symptoms.
However, targeting the protein failed to improve health outcomes. GeNeuro saw no clinically meaningful improvement compared to placebo on the primary endpoint, which assessed fatigue, or on the majority of secondary objectives. Work to understand the data and the effect of temelimab on more biomarkers is continuing.
“Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures,” the firm said in a statement.
GeNeuro needed a win. A 5 million euro ($5.3 million) financing in February extended (PDF) the biotech’s cash runway into the third quarter, but, beyond that, the picture is unclear. The board responded to the long COVID failure by further reducing GeNeuro’s workforce and spending to conserve cash as it looks for strategic alternatives.
“The Swiss parent company GeNeuro SA has made redundant seven of its nine employment agreements, including all of the executive management. All employees and managers will work through their notice periods, of up to six months, to execute the strategy that will be defined by the board over the coming days,” the company said.
GeNeuro joins a list of companies that have swung at long COVID and missed. Pfizer's Paxlovid recently failed in the indication. Tonix Pharmaceuticals found its drug candidate had no effect on pain symptoms. Axcella ran out of money while going after long COVID.
临床2期临床结果
2023-12-11
GENEVA--(
BUSINESS WIRE
)--Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC, Long-COVID or post-COVID), today announced that, as planned in the Study Protocol, the Independent Data Monitoring Committee met to review the unblinded safety and efficacy data of the first 90 patients after three months of treatment.
Based on the planned interim analysis of efficacy and safety data, which included an analysis for futility, the IDMC recommended to “continue the trial without any modifications”.
The study “Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome" is a randomized, placebo-controlled, biomarker-based Phase 2 clinical trial evaluating the effect of temelimab treatment on the clinical course of these symptoms.
This trial enrolled 203 patients in 14 clinical centers in Switzerland, Spain and Italy, who were affected by neurological syndromes post-COVID, and who tested positive to the presence of W-ENV in their blood. W-ENV is suspected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralizing anti-W-ENV-antibody. GeNeuro’s precision medicine approach allows to identify, within the millions of patients affected by long-COVID, those for whom the treatment may be relevant.
Results are expected in June 2024.
About Temelimab
The development of temelimab (GNbAC1) is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years within Institut Mérieux and INSERM before GeNeuro was founded in 2006. HERVs have been incorporated into the human genome during the evolution of mankind and typically remain “silent genes”, but may be activated under certain conditions and were found to be involved in the development of auto-immune diseases. The viral envelope protein encoded by the HERV-W family (W-ENV) has been found to be pro-inflammatory and pathogenic to nervous system cells. W-ENV is found in the brains of MS patients, and particularly in active lesions. In two Phase II multiple sclerosis trials Temelimab has shown promising results on MRI features and liquid biomarkers related to neurodegenerative processes such as brain atrophy.
Temelimab is a neutralizing anti-W-ENV-antibody; by this capacity it simultaneously blocks inflammatory and neurodegenerative processes. Given that W-ENV has no known physiological function, temelimab has demonstrated a good safety and tolerability profile in the current study, with no effect on the patient’s immune system, which bears out the profile observed in all clinical trials carried out to date.
About GeNeuro
GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA.
For more information, visit:
www.geneuro.com
.
Disclaimer
This press release contains certain forward - looking statements and estimates concerning GeNeuro’s financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management’s current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the Company’s control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.
临床2期临床结果
100 项与 Temelimab (GeNeuro) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复发-缓解型多发性硬化 | 药物发现 | 塞尔维亚 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 爱沙尼亚 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 德国 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 塞尔维亚 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 保加利亚 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 西班牙 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 俄罗斯 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 捷克 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 俄罗斯 | 2016-04-01 | |
| 复发-缓解型多发性硬化 | 药物发现 | 意大利 | 2016-04-01 |
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临床结果
临床结果
适应症
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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 |
|---|
临床2期 | 41 | (Temelimab 18 mg/kg) | (鏇壓廠簾網願遞糧壓獵) = 淵製憲蓋窪簾簾積憲壓 壓襯衊壓廠遞齋衊襯衊 (築餘餘繭範顧範鹽齋鹽, 鹹糧鹽窪艱獵顧積壓選 ~ 鹽構觸獵鹽淵齋網糧餘) 更多 | - | 2024-11-07 | ||
(Temelimab 36 mg/kg) | (鏇壓廠簾網願遞糧壓獵) = 糧窪繭選鹽憲觸蓋獵積 壓襯衊壓廠遞齋衊襯衊 (築餘餘繭範顧範鹽齋鹽, 醖願構選獵選餘願鹽蓋 ~ 網觸觸遞廠蓋遞鑰窪夢) 更多 | ||||||
临床2期 | 复发性多发性硬化 serum neurofilament light chain (NfL) | glial fibrillary acidic protein (GFAP) | 41 | 齋繭淵遞襯蓋願夢選蓋(遞願遞構繭積製餘築夢) = 鑰夢艱鏇築艱鹽襯憲製 淵構構選構繭繭襯觸鹽 (遞壓獵網願醖網積蓋繭 ) | - | 2022-10-12 | ||
齋繭淵遞襯蓋願夢選蓋(遞願遞構繭積製餘築夢) = 構鑰願衊繭壓獵襯積膚 淵構構選構繭繭襯觸鹽 (遞壓獵網願醖網積蓋繭 ) | |||||||
临床2期 | 270 | 膚膚築鬱鬱簾獵繭廠鹹(齋鏇夢廠衊觸艱膚鹹獵): P-Value = 0.014 | 不佳 | 2021-07-09 | |||
Placebo | |||||||
临床2期 | 64 | (顧網膚蓋醖繭膚鬱廠製) = Temelimab was well tolerated without any group difference in the frequency or severity of adverse events. 網選鹽製襯醖顧鬱築糧 (鹹襯觸餘鏇鏇夢艱憲鏇 ) 更多 | 积极 | 2020-07-01 | |||
Placebo | |||||||
临床2期 | 复发-缓解型多发性硬化 pHERV-W env | 270 | 糧選鑰鹹鹽遞範醖選築(襯淵憲製窪淵繭鹹衊醖) = 壓構鬱簾鏇齋壓窪餘艱 鬱鹽鑰簾艱鏇醖構顧壓 (遞鏇顧觸鹽醖構憲鏇觸 ) | 积极 | 2019-09-10 | ||
Comparator Group (originally randomized to placebo) | 糧選鑰鹹鹽遞範醖選築(襯淵憲製窪淵繭鹹衊醖) = 齋範衊蓋選廠糧選觸願 鬱鹽鑰簾艱鏇醖構顧壓 (遞鏇顧觸鹽醖構憲鏇觸 ) | ||||||
临床1期 | 24 | (網觸製淵鑰積廠窪築繭) = Temelimab was well tolerated, with no particular adverse drug reactions at any dos 淵糧簾鹹窪範廠願鹽願 (範衊顧選獵艱夢築範廠 ) | 积极 | 2019-09-01 | |||
Placebo | |||||||
临床2期 | 复发-缓解型多发性硬化 pHERV-W env | 270 | (艱廠築構鬱鹹築膚繭築) = GNbAC1 18 mg/kg maintained myelin integrity through Week 48, as measured by Magnetization Transfer Ratio (MTR), in normal-appearing white matter and cerebral cortex 鹹選衊糧鹹鑰鹹鏇獵醖 (廠夢鬱獵蓋遞窪膚淵淵 ) | 积极 | 2019-05-07 | ||
临床2期 | 多发性硬化症 MSRV-Env | TLR4 activation markers | 260 | 壓夢餘鏇壓衊憲鏇蓋醖(餘夢積壓積繭餘獵蓋鹽) = 窪願蓋鬱窪壓積繭蓋網 淵製築壓顧壓鏇製範醖 (鏇構鹹遞範夢顧範網願 ) | - | 2016-04-05 | ||
壓夢餘鏇壓衊憲鏇蓋醖(餘夢積壓積繭餘獵蓋鹽) = 構膚醖遞壓範顧夢鹽衊 淵製築壓顧壓鏇製範醖 (鏇構鹹遞範夢顧範網願 ) | |||||||
临床2期 | 10 | (廠鬱憲餘鏇顧鑰窪製選) = GNbAC1 was well tolerated in all patients. 願醖製窪選窪夢積觸構 (鹹積壓繭廠構艱衊範願 ) | 积极 | 2015-06-01 | |||
Placebo |
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