Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.

开始日期2024-04-01

申办/合作机构

Stanford University

NCT05187403 / Completed临床1期

A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops

This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.

开始日期2021-12-09

申办/合作机构

Active Biotech AB

NL-OMON43112 / CompletedN/A

A randomized, open-label, two-way crossover study to assess the relative bioavailability of Laquinimod 0.6 mg test tablet versus Laquinimod 0.6 mg reference capsule after single dose administration with a single sequence extension to assess the pharmacokinetics of Laquinimod and its metabolites after single and multiple oral 0.6 mg dose administration in healthy subjects. - Bioavailability study Laquinimod test tablets

开始日期2016-10-05

申办/合作机构

Teva Pharmaceutical Industries Ltd.

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2024-01-24·The Lancet. Neurology

Laquinimod, Huntington's disease, and disease modification.

Article

作者: Tiago A Mestre

2024-01-24·The Lancet. Neurology

Safety and efficacy of laquinimod for Huntington's disease (LEGATO-HD): a multicentre, randomised, double-blind, placebo-controlled, phase 2 study.

Article

作者: Ralf Reilmann ; Karen E Anderson ; Andrew Feigin ; Sarah J Tabrizi ; Blair R Leavitt ; Julie C Stout ; Paola Piccini ; Robin Schubert ; Pippa Loupe ; Anna Wickenberg ; Beth Borowsky ; Gail Rynkowski ; Rita Volkinshtein ; Thomas Li ; Juha-Matti Savola ; Michael Hayden ; Mark Forrest Gordon ; LEGATO-HD Study Group

BACKGROUND:

Laquinimod modulates CNS inflammatory pathways thought to be involved in the pathology of Huntington's disease. Studies with laquinimod in transgenic rodent models of Huntington's disease suggested improvements in motor function, reduction of brain volume loss, and prolonged survival. We aimed to evaluate the safety and efficacy of laquinimod in improving motor function and reducing caudate volume loss in patients with Huntington's disease.

METHODS:

LEGATO-HD was a multicentre, double-blind, placebo-controlled, phase 2 study done at 48 sites across ten countries (Canada, Czech Republic, Germany, Italy, Netherlands, Portugal, Russia, Spain, UK, and USA). Patients aged 21-55 years with a cytosine-adenosine-guanine (CAG) repeat length of between 36 and 49 who had symptomatic Huntington's disease with a Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) of higher than 5 and a Total Functional Capacity score of 8 or higher were randomly assigned (1:1:1:1) by centralised interactive response technology to laquinimod 0·5 mg, 1·0 mg, or 1·5 mg, or to matching placebo, administered orally once daily over 52 weeks; people involved in the randomisation had no other role in the study. Participants, investigators, and study personnel were masked to treatment assignment. The 1·5 mg group was discontinued before recruitment was finished because of cardiovascular safety concerns in multiple sclerosis studies. The primary endpoint was change from baseline in the UHDRS-TMS and the secondary endpoint was percent change in caudate volume, both comparing the 1·0 mg group with the placebo group at week 52. Primary and secondary endpoints were assessed in the full analysis set (ie, all randomised patients who received at least one dose of study drug and had at least one post-baseline UHDRS-TMS assessment). Safety measures included adverse event frequency and severity, and clinical and laboratory examinations, and were assessed in the safety analysis set (ie, all randomised patients who received at least one dose of study drug). This trial is registered with ClinicalTrials.gov, NCT02215616, and EudraCT, 2014-000418-75, and is now complete.

FINDINGS:

Between Oct 28, 2014, and June 19, 2018, 352 adults with Huntington's disease (179 [51%] men and 173 [49%] women; mean age 43·9 [SD 7·6] years and 340 [97%] White) were randomly assigned: 107 to laquinimod 0·5 mg, 107 to laquinimod 1·0 mg, 30 to laquinimod 1·5 mg, and 108 to matching placebo. Least squares mean change from baseline in UHDRS-TMS at week 52 was 1·98 (SE 0·83) in the laquinimod 1·0 mg group and 1·2 (0·82) in the placebo group (least squares mean difference 0·78 [95% CI -1·42 to 2·98], p=0·4853). Least squares mean change in caudate volume was 3·10% (SE 0·38) in the 1·0 mg group and 4·86% (0·38) in the placebo group (least squares mean difference -1·76% [95% CI -2·67 to -0·85]; p=0·0002). Laquinimod was well tolerated and there were no new safety findings. Serious adverse events were reported by eight (7%) patients on placebo, seven (7%) on laquinimod 0·5 mg, five (5%) on laquinimod 1·0 mg, and one (3%) on laquinimod 1·5 mg. There was one death, which occurred in the placebo group and was unrelated to treatment. The most frequent adverse events in all laquinimod dosed groups (0·5 mg, 1·0 mg, and 1·5 mg) were headache (38 [16%]), diarrhoea (24 [10%]), fall (18 [7%]), nasopharyngitis (20 [8%]), influenza (15 [6%]), vomiting (13 [5%]), arthralgia (11 [5%]), irritability (ten [4%]), fatigue (eight [3%]), and insomnia (eight [3%]).

INTERPRETATION:

Laquinimod did not show a significant effect on motor symptoms assessed by the UHDRS-TMS, but significantly reduced caudate volume loss compared with placebo at week 52. Huntington's disease has a chronic and slowly progressive course, and this study does not address whether a longer duration of laquinimod treatment could have produced detectable and meaningful changes in the clinical assessments.

FUNDING:

Teva Pharmaceutical Industries.

2024-01-04·The Cochrane database of systematic reviews

Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.

Review

作者: Marien Gonzalez-Lorenzo ; Ben Ridley ; Silvia Minozzi ; Cinzia Del Giovane ; Guy Peryer ; Thomas Piggott ; Matteo Foschi ; Graziella Filippini ; Irene Tramacere ; Elisa Baldin ; Francesco Nonino

BACKGROUND:

Different therapeutic strategies are available for the treatment of people with relapsing-remitting multiple sclerosis (RRMS), including immunomodulators, immunosuppressants and biological agents. Although each one of these therapies reduces relapse frequency and slows disability accumulation compared to no treatment, their relative benefit remains unclear. This is an update of a Cochrane review published in 2015.

OBJECTIVES:

To compare the efficacy and safety, through network meta-analysis, of interferon beta-1b, interferon beta-1a, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, pegylated interferon beta-1a, daclizumab, laquinimod, azathioprine, immunoglobulins, cladribine, cyclophosphamide, diroximel fumarate, fludarabine, interferon beta 1-a and beta 1-b, leflunomide, methotrexate, minocycline, mycophenolate mofetil, ofatumumab, ozanimod, ponesimod, rituximab, siponimod and steroids for the treatment of people with RRMS.

SEARCH METHODS:

CENTRAL, MEDLINE, Embase, and two trials registers were searched on 21 September 2021 together with reference checking, citation searching and contact with study authors to identify additional studies. A top-up search was conducted on 8 August 2022.

SELECTION CRITERIA:

Randomised controlled trials (RCTs) that studied one or more of the available immunomodulators and immunosuppressants as monotherapy in comparison to placebo or to another active agent, in adults with RRMS.

DATA COLLECTION AND ANALYSIS:

Two authors independently selected studies and extracted data. We considered both direct and indirect evidence and performed data synthesis by pairwise and network meta-analysis. Certainty of the evidence was assessed by the GRADE approach.

MAIN RESULTS:

We included 50 studies involving 36,541 participants (68.6% female and 31.4% male). Median treatment duration was 24 months, and 25 (50%) studies were placebo-controlled. Considering the risk of bias, the most frequent concern was related to the role of the sponsor in the authorship of the study report or in data management and analysis, for which we judged 68% of the studies were at high risk of other bias. The other frequent concerns were performance bias (34% judged as having high risk) and attrition bias (32% judged as having high risk). Placebo was used as the common comparator for network analysis. Relapses over 12 months: data were provided in 18 studies (9310 participants). Natalizumab results in a large reduction of people with relapses at 12 months (RR 0.52, 95% CI 0.43 to 0.63; high-certainty evidence). Fingolimod (RR 0.48, 95% CI 0.39 to 0.57; moderate-certainty evidence), daclizumab (RR 0.55, 95% CI 0.42 to 0.73; moderate-certainty evidence), and immunoglobulins (RR 0.60, 95% CI 0.47 to 0.79; moderate-certainty evidence) probably result in a large reduction of people with relapses at 12 months. Relapses over 24 months: data were reported in 28 studies (19,869 participants). Cladribine (RR 0.53, 95% CI 0.44 to 0.64; high-certainty evidence), alemtuzumab (RR 0.57, 95% CI 0.47 to 0.68; high-certainty evidence) and natalizumab (RR 0.56, 95% CI 0.48 to 0.65; high-certainty evidence) result in a large decrease of people with relapses at 24 months. Fingolimod (RR 0.54, 95% CI 0.48 to 0.60; moderate-certainty evidence), dimethyl fumarate (RR 0.62, 95% CI 0.55 to 0.70; moderate-certainty evidence), and ponesimod (RR 0.58, 95% CI 0.48 to 0.70; moderate-certainty evidence) probably result in a large decrease of people with relapses at 24 months. Glatiramer acetate (RR 0.84, 95%, CI 0.76 to 0.93; moderate-certainty evidence) and interferon beta-1a (Avonex, Rebif) (RR 0.84, 95% CI 0.78 to 0.91; moderate-certainty evidence) probably moderately decrease people with relapses at 24 months. Relapses over 36 months findings were available from five studies (3087 participants). None of the treatments assessed showed moderate- or high-certainty evidence compared to placebo. Disability worsening over 24 months was assessed in 31 studies (24,303 participants). Natalizumab probably results in a large reduction of disability worsening (RR 0.59, 95% CI 0.46 to 0.75; moderate-certainty evidence) at 24 months. Disability worsening over 36 months was assessed in three studies (2684 participants) but none of the studies used placebo as the comparator. Treatment discontinuation due to adverse events data were available from 43 studies (35,410 participants). Alemtuzumab probably results in a slight reduction of treatment discontinuation due to adverse events (OR 0.39, 95% CI 0.19 to 0.79; moderate-certainty evidence). Daclizumab (OR 2.55, 95% CI 1.40 to 4.63; moderate-certainty evidence), fingolimod (OR 1.84, 95% CI 1.31 to 2.57; moderate-certainty evidence), teriflunomide (OR 1.82, 95% CI 1.19 to 2.79; moderate-certainty evidence), interferon beta-1a (OR 1.48, 95% CI 0.99 to 2.20; moderate-certainty evidence), laquinimod (OR 1.49, 95 % CI 1.00 to 2.15; moderate-certainty evidence), natalizumab (OR 1.57, 95% CI 0.81 to 3.05), and glatiramer acetate (OR 1.48, 95% CI 1.01 to 2.14; moderate-certainty evidence) probably result in a slight increase in the number of people who discontinue treatment due to adverse events. Serious adverse events (SAEs) were reported in 35 studies (33,998 participants). There was probably a trivial reduction in SAEs amongst people with RRMS treated with interferon beta-1b as compared to placebo (OR 0.92, 95% CI 0.55 to 1.54; moderate-certainty evidence).

AUTHORS' CONCLUSIONS:

We are highly confident that, compared to placebo, two-year treatment with natalizumab, cladribine, or alemtuzumab decreases relapses more than with other DMTs. We are moderately confident that a two-year treatment with natalizumab may slow disability progression. Compared to those on placebo, people with RRMS treated with most of the assessed DMTs showed a higher frequency of treatment discontinuation due to AEs: we are moderately confident that this could happen with fingolimod, teriflunomide, interferon beta-1a, laquinimod, natalizumab and daclizumab, while our certainty with other DMTs is lower. We are also moderately certain that treatment with alemtuzumab is associated with fewer discontinuations due to adverse events than placebo, and moderately certain that interferon beta-1b probably results in a slight reduction in people who experience serious adverse events, but our certainty with regard to other DMTs is lower. Insufficient evidence is available to evaluate the efficacy and safety of DMTs in a longer term than two years, and this is a relevant issue for a chronic condition like MS that develops over decades. More than half of the included studies were sponsored by pharmaceutical companies and this may have influenced their results. Further studies should focus on direct comparison between active agents, with follow-up of at least three years, and assess other patient-relevant outcomes, such as quality of life and cognitive status, with particular focus on the impact of sex/gender on treatment effects.

项与拉喹莫德相关的新闻（医药）

2022-06-01

·GlobeNewswire-Health Care

Successful completion of the first stage of the phase IIa clinical trial of naptumomab in combination with docetaxel and the study is now enrolling into the second stage

Lund, June 1, 2022 - Active Biotech (NASDAQ STOCKHOLM: ACTI) and its partner NeoTX announce today the successful completion of the first stage of a Simon 2 stage phase IIa clinical trial of naptumomab estafenatox (NAP, naptumomab), in combination with docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors (CPIs). In the study, the patients are treated with NAP for 4 consecutive days and with docetaxel at a standard dose on day 5 in 21-day treatment cycles. The first stage of this trial required a minimum of two responses out of ten patients to move to the second stage of the trial, which is now enrolling. For more information about the trial, visit www.clinicaltrials.gov. NCT04880863 We are pleased by these early encouraging observations and are excited to follow the progress of the trial, which is now enrolling in its second stage, says Erik Vahtola, Chief Medical Officer at Active Biotech. Patients with advanced NSCLC who have progressed on CPI and standard chemotherapy currently have limited treatment options and new treatment alternatives are needed.See also www.neotx.com for NeoTX’s communication related to this information. Helén Tuvesson President & CEO For further information, please contact: Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.com Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com This information is information that Active Biotech is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 14.00 pm. CET on June 1, 2022. Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: The wholly owned small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is in a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II for treatment of non-infectious uveitis. Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. Please visit www.activebiotech.com for more information. About NeoTX NeoTX is a clinical-stage immuno-oncology company which is developing targeted anticancer immunotherapies utilizing its proprietary Tumor Targeted Superantigen (TTS) platform. TTS binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating and expanding tumor specific immune cells that are then redirected from the periphery to the tumor to mount an effective response. The company’s lead TTS molecule, naptumomab estafenatox is currently in clinical development for advanced solid tumors (clinicaltrials.gov/NCT039883954 and NCT04880863). Please visit www.neotx.com for more information. Naptumomab was licensed from Active Biotech to NeoTX Therapeutics Ltd in 2016. NeoTX is responsible for the global development and commercialization of naptumomab for the treatment of cancer under the license agreement. Active Biotech AB(Corp. Reg. No. 556223-9227)Scheelevägen 22, SE-223 63 Lund, SwedenTel: +46 (0)46 19 20 00 Attachment 220601_phase IIa clinical trial naptumomab in combination with docetaxel

First in Class免疫疗法小分子药物合作

2021-10-03

·BioSpace

Active Biotech: Tasquinimod clinical development in multiple myeloma advances into combination therapy following completion of the initial phase of the ongoing trial in the US

Lund Sweden, October 3, 2021 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces that the ongoing trial of tasquinimod in multiple myeloma has reached an important milestone. Ten patients have been treated with increasing doses of tasquinimod, which was generally well tolerated. The optimal dose and schedule of tasquinimod, when used as a single agent in patients with multiple myeloma has been established at 1 mg per day after a one-week run in of 0.5 mg daily. This is similar to the treatment schedule used in previous studies of tasquinimod. The trial will now advance to a previously planned combination part, in which treatment with tasquinimod will be tested in patients with multiple myeloma together with the orally administered antimyeloma agents ixazomib, lenalidomide, and dexamethasone (IRd). Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients. Key secondary endpoints will include antimyeloma activity using the response criteria of the International Myeloma Working Group. The study is conducted in a partnership with the Abramson Cancer Center of the University of Pennsylvania, with Dr. Dan Vogl as principal investigator. For more information about the study please visit clinical clinicaltrials.gov (NCT04405167). "We are pleased to have concluded the first part of this trial, confirming the previous safety pro tasquinimod in patients with multiple myeloma and defining an optimal dose and schedule for tasquinimod in this patient population. The patients included in this study phase were heavily pre-treated, with a median of 8 prior lines of therapy; 8 of the 10 patients were triple-class refractory to Imids, proteasome inhibitors, and anti-CD38 monoclonal antibodies. While none of the patients formally achieved a partial response, two patients with progressive myeloma at study entry achieved significant periods of stable disease on single-agent tasquinimod therapy. This suggests that tasquinimod has anti-myeloma activity in patients with advanced disease that is resistant to established therapies. These results enable us to advance into the combination part of the study, in which tasquinimod will be combined with a standard anti-myeloma treatment regimen. Our preclinical laboratory models suggest that this combination strategy may be a particularly effective way to utilize tasquinimod in myeloma therapy." says Dr. Dan Vogl, Principal Investigator. “We are enthusiastic to have reached this milestone and can conclude the first phase of this study. Based on the established safety data together with the encouraging anti-myeloma activities observed, we look forward to the continuation of the study. In the coming phase, tasquinimod will be evaluated in combination with ixazomib, lenalidomide, and dexamethasone (IRd), which already are established in the clinical practice. The use of tasquinimod, as a novel class of treatment for multiple myeloma, in combination with treatments used for earlier stage patients, is aligned with our current understanding of the mechanism of action of tasquinimod in these patients. ” says Helén Tuvesson, CEO, Active Biotech AB. Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 21:30 p.m. CET on October 3, 2021. About tasquinimod Tasquinimod is an oral immunomodulatory and anti-angiogenic investigational treatment, that affects the tumor's ability to grow and metastasize. Tasquinimod is developed as a new immunomodulatory treatment for multiple myeloma. Tasquinimod has previously been studied as an anti-cancer agent in patients with solid cancers, including a phase 3 randomized trial in patients with metastatic prostate cancer. The tolerability of tasquinimod is well-characterized based on these previous experiences. Tasquinimod has demonstrated a clear therapeutic potential in preclinical models of multiple myeloma, when used as a single agent and in combination with standard multiple myeloma therapy. About multiple myeloma Multiple myeloma is an incurable blood cancer in which abnormal plasma cells in the bone marrow grow uncontrollably while other blood forming cells such as white and red blood cells and blood platelets are suppressed. This leads to anemia, infections, destruction of bone tissue and progressive loss of renal function. Despite new treatments have greatly improved survival of multiple myeloma patients, the biological heterogeneity of the disease and the emergence of drug resistance is a major challenge, and the medical need of innovative treatment modalities remains high. In 2017, 81000 new cases of multiple myeloma were diagnosed in the eight major markets. The global sales of drugs for multiple myeloma totaled USD 16 billion in 2017 and sales are expected to increase 48% by 2026 (ref Global Data 2019). Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. The small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is advancing to a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II for treatment of non-infectious uveitis. Please visit for more information. Active Biotech AB (Corp. Reg. No. 556223-9227) Scheelevägen 22, SE-223 63 Lund, Sweden Tel: +46 (0)46 19 20 00 Attachment 211003_Tasquinimod clinical development in multiple myeloma

抗体First in Class免疫疗法小分子药物合作

2021-07-08

·GlobeNewswire

Active Biotech's partner NeoTX will host KOL webinar on

Lund, July 8 2021 - Active Biotech (Nasdaq Stockholm: ACTI) today provided information that its partner in the naptumomab project, NeoTX will host a key opinion leader (KOL) webinar on overcoming checkpoint inhibitor resistance on Wednesday, July 14th at 10 am eastern time (ET) The webinar will feature a presentation by KOL Mario Sznol, MD, Yale Cancer Center, who will discuss New Frontiers for Checkpoint Inhibitors in Immuno-Oncology. NeoTX's management will also give an update on their Tumor Targeted Superantigen (TTS) platform’s lead candidate, naptumomab estafenatox (naptumomab) in overcoming resistance. Naptumomab is being evaluated in combination with chemotherapy, checkpoint inhibitors and CAR T. Dr. Sznol and NeoTX management will be available to answer questions following the formal presentations. See also neotx.com/press-releases for NeoTX’s communication and for registration for the event. Since 2016, Active Biotech has a licensing agreement with NeoTX Therapeutics Ltd. for the worldwide development and commercialization of naptumomab for cancer therapy. For further information, please contact:Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.comHans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com This information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CET on July 8, 2021. Active BiotechActive Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. The small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is advancing to phase II for treatment of non-infectious uveitis during second half of 2021. Please visit www. Active Biotech AB (Corp. Reg. No. 556223-9227)Scheelevägen 22, SE-223 63 Lund, SwedenTel: +46 (0)46 19 20 00 Attachment

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KEGG	Wiki	ATC	Drug Bank
D08938	拉喹莫德	N07XX10	DB06685

研发状态

适应症	最高研发状态	国家/地区	公司
多发性硬化症	批准上市	俄罗斯更多	Active Biotech AB 更多
葡萄膜炎	临床前	瑞典更多	Active Biotech AB 更多
复发-缓解型多发性硬化	终止	德国更多	Teva Pharmaceutical Industries Ltd. 更多

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临床结果

适应症

分期

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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


LEGATO-HD (MDS2019)	临床2期	亨廷顿舞蹈病	-	Laquinimod 1.0 mg	齋觸鹹範鹽廠艱構鏇餘(鹹鏇鑰衊蓋衊蓋窪齋鏇) = 鏇壓網願蓋願願艱淵範餘齋醖餘構膚鑰顧鬱壓 (鏇積築簾觸鹹鑰膚鏇淵 )	不佳	2019-09-22
				Placebo	齋觸鹹範鹽廠艱構鏇餘(鹹鏇鑰衊蓋衊蓋窪齋鏇) = 艱遞鏇壓窪範顧築鑰顧餘齋醖餘構膚鑰顧鬱壓 (鏇積築簾觸鹹鑰膚鏇淵 )
NCT01707992 (CONCERTO, Pubmed \| Mult Scler)	临床3期	复发-缓解型多发性硬化	2,199	Laquinimod 0.6 mg	(蓋遞鬱壓夢醖範憲醖繭) = 顧選觸顧簾夢積範餘壓觸網願鏇積醖鹽醖廠醖 (遞蓋鹽憲網廠襯顧糧觸 )	不佳	2021-08-11
ALLEGRO and BRAVO (AAN2016)	临床3期	复发-缓解型多发性硬化	2,347	Laquinimod 0.6 mg	(窪艱齋餘壓製鹽遞餘餘) = 壓窪鹹範襯鑰憲淵襯積製窪顧糧鹹簾夢淵範廠 (鬱觸簾鏇淵壓築簾壓壓 ) 更多	积极	2016-04-05
NCT00737932 (Pubmed \| Gut) 人工标引	临床2期	克罗恩病	180	laquinimod	(襯壓窪選觸簾襯築餘夢) = 獵窪夢製夢醖顧壓夢衊餘艱觸窪範壓襯糧廠艱 (構蓋獵積襯衊繭願鹹積, 31 ~ 66) 更多	积极	2015-08-01
				Placebo	(襯壓窪選觸簾襯築餘夢) = 願鬱築壓廠獵憲鏇顧衊餘艱觸窪範壓襯糧廠艱 (構蓋獵積襯衊繭願鹹積, 9 ~ 27) 更多
AAN2014	N/A	自身免疫性疾病	-	Laquinimod	蓋壓網製願衊淵繭蓋糧(窪鹹襯膚顧憲積顧鏇齋) = 簾願簾醖憲築積夢築鏇簾遞鏇鹽壓簾糧廠蓋築 (膚蓋選觸壓網窪憲蓋選 )	-	2014-04-08
AAN2014	N/A	复发-缓解型多发性硬化	-	Laquinimod	憲憲膚憲構鬱簾餘顧積(選簾範淵網餘鬱齋鹹願): OR = 0.56 (95% CI, 0.4 ~ 0.78)	-	2014-04-08
				Placebo
AAN2016	N/A	-	1,990	Laquinimod 0.6 mg	(觸獵夢願鏇範築鬱壓製): adjusted mean difference = 0.39 (95% CI, 0.21 ~ 0.58)	-	2016-04-05
				Placebo
NCT00509145 (Pubmed) 人工标引	临床3期	多发性硬化症	1,106	laquinimod	(簾鬱蓋窪範選糧鹹製襯) = 艱壓願醖壓遞醖鹹遞窪窪觸膚壓醖鹽窪鑰艱齋 (夢鹹憲顧衊範憲網鏇糧, 0.02) 更多	积极	2012-03-15
				Placebo	(簾鬱蓋窪範選糧鹹製襯) = 蓋廠積製鑰窪鹹觸艱鬱窪觸膚壓醖鹽窪鑰艱齋 (夢鹹憲顧衊範憲網鏇糧, 0.03) 更多
NCT02284568 (ARPEGGIO, Pubmed \| Ann Neurol)	临床2期	原发性进行性多发性硬化	374	Laquinimod 0.6 mg	範艱鑰製遞艱憲鏇範壓(願鹹積積壓壓壓鬱鬱鹹): risk ratio = 0.4 (95% CI, 0.26 ~ 0.69) 更多	不佳	2020-07-10
				Placebo
NCT02215616 (LEGATO-HD, AAN2019) 人工标引	临床2期	亨廷顿舞蹈病	-	laquinimod	- 更多	不佳	2019-04-16
				Placebo