Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

开始日期2024-03-20

申办/合作机构

Bayer AG

[+3]

NCT05658497

/ RecruitingN/A

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

开始日期2023-10-27

申办/合作机构

Biogen, Inc.

PACTR202205508723236

/ Suspended临床3期IIT

A multi-centre, placebo-controlled studyof interferon beta-1a in high risk COVID-19 outpatients (InterCoV)

开始日期2022-05-15

申办/合作机构-

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项与干扰素β-1a(Biogen, Inc.) 相关的文献（医药）

2024-12-01·Journal of Central Nervous System Disease

Five-year efficacy outcomes of ocrelizumab in relapsing multiple sclerosis: A propensity-matched comparison of the OPERA studies with other disease-modifying therapies in real-world lines of treatments

Article

作者: Bergmann, Arnfin ; Model, Fabian ; van Hövell, Philip ; Heer, Yanic ; Craveiro, Licinio ; Yiu, Sean ; Bernasconi, Corrado ; Muros-Le Rouzic, Erwan ; Tozzi, Viola ; Braune, Stefan

Background:

Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking.

Objectives:

To compare the treatment effect of OCR vs six DMTs’ (IFN β-1a, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, natalizumab) treatment pathways used in clinical practice by combining clinical trial and real-world data.

Methods:

Patient-level data from OPERA trials and open-label extension phase, and from the German NeuroTransData (NTD) MS registry, were used to build 1:1 propensity score-matched (PSM) cohorts controlling for seven baseline covariates, including brain imaging activity. Efficacy outcomes were time to first relapse and time to 24-week confirmed disability progression over 5.5 years of follow-up. Intention-to-treat analysis using all outcome data irrespective of treatment switch was applied.

Results:

The analyses included 611 OPERA patients and 7141 NTD patients. We built 12 paired-matched cohorts (six for each outcome, two for each DMT) to compare efficacy of OCR in OPERA with each DMT treatment pathway in NTD. Post-matching, baseline covariates and PS were well balanced (standardized mean difference <.2 for all cohorts). Over 5.5 years, patients treated with OCR showed a statistically significant reduction in the risk of relapse (hazard ratios [HRs] .30 to .54) and disability progression (HRs .51 to .67) compared with all index therapies and their treatment switching pathways in NTD. Treatment switch and/or discontinuation occurred frequently in NTD cohorts.

Conclusion:

OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period. These analyses suggest that high-efficacy DMTs and high treatment persistence are critical to achieve greatest clinical benefit in RMS.

Registration:

OPERA I (NCT01247324), OPERA II (NCT01412333)

2024-11-01·Journal of Managed Care & Specialty Pharmacy

Patient-reported disability progression outcomes among patients with multiple sclerosis: Results of an outcomes-based agreement

Article

作者: Good, Chester B. ; Alderson, Jacqueline ; Maxwell, RaeAnn ; Swart, Elizabeth C.S. ; Peasah, Samuel K. ; Manolis, Chronis

BACKGROUND:

Outcomes-based agreements (OBAs) are agreements between payers and manufacturers in which payment for medications is tied to patient outcomes. These contracts aim to measure the value of prescription medications on predefined clinical indicators in real-world patient populations. OBAs are gaining traction in the United States as the health care industry shifts from volume-based to value-based care. Multiple sclerosis (MS) is an appealing therapeutic area for OBAs because of its prevalence, high cost of medications, and multiple effective therapeutic options.

OBJECTIVE:

To describe findings from an OBA that was prospectively conducted in a large regional health system for patients with MS taking interferon β-1a or dimethyl fumarate.

METHODS:

In this prospective real-world analysis, commercial or health insurance exchange members were included based on the parameters of the OBA. Disability progression was assessed using a patient-reported outcome, patient-determined disease steps (PDDS). In the OBA, members aged 18 years or older with an MS diagnosis were included in the contract. A baseline score was collected for eligible members, with follow-up scores occurring between a 90-day and 180-day postbaseline score. If a follow-up score was greater than the baseline score, a subsequent PDDS score was collected between 90-days and 120-days to determine if the PDDS score remained elevated, indicating that the member had disability progression.

RESULTS:

During the contract period, 410 patients were eligible for PDDS collection, with 241 and 169 patients in the dimethyl fumarate and interferon β-1a cohorts, respectively. There were 162 patients who were lost to follow-up, and 64 patients who were ineligible per contract parameters. Of the remaining 184 eligible patients (107 on dimethyl fumarate and 77 on interferon β-1a), 21 (11%) patients had confirmed disability progression (6 on dimethyl fumarate [5.6%] and 15 on interferon β-1a [19.5%]).

CONCLUSIONS:

Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA.

2024-10-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY)

Article

作者: Saeidi, Morteza ; Ghiasian, Masoud ; Baghbanian, Seyed Mohammad ; Abolfazli, Roya ; Ayromlou, Hormoz ; Ghalyanchi Langroodi, Hamidreza ; Asadollahzadeh, Elnaz ; Shaygannejad, Vahid ; Beladi Moghadam, Nahid ; Ashtari, Fereshteh ; Kafi, Hamidreza ; Sabzvari, Araz ; Azimi Saeen, Amirreza

BACKGROUND:

Multiple sclerosis (MS) is a prevalent, disabling, inflammatory, neurodegenerative disease that typically manifests during a highly productive stage of life. Interferon beta-1a was among the first approved disease-modifying therapies for MS and remains among the first-line treatment options. Pegylation of the interferon beta-1a molecule prolongs its half-life while maintaining its efficacy and safety profile. In PEGINTEGRITY study, we aimed to compare peginterferon beta-1a with interferon beta-1a in terms of efficacy and safety in relapsing-remitting multiple sclerosis (RRMS) patients.

METHODS:

This study was a randomized, active-controlled, parallel-group, multi-center Phase 3 trial conducted in Iran in participants with RRMS. Participants received 125 µg of subcutaneous peginterferon beta-1a every two weeks or 30 µg of intramuscular interferon beta-1a once a week for up to 96 weeks. The primary outcome was the non-inferiority of peginterferon beta-1a to interferon beta-1a in reducing annualized relapse rate (ARR). Other outcomes included the number of patients with 12-week confirmed disability progression, the number of new or newly-enlarging T2 hyperintense lesions, the number of gadolinium-enhancing lesions, the number of new T1 hypointense lesions, the volume of new or newly-enlarging T2 hyperintense lesions, changes in brain volume, immunogenicity, and safety assessments.

RESULTS:

A total of 168 patients who met the eligibility criteria were enrolled and assigned to two arms of the study, each consisting of 84 participants. Totally, 41 participants (24 patients in the peginterferon beta-1a group and 17 patients in the interferon beta-1a group) were withdrawn from the study. The withdrawn patients were included in the per-protocol analysis for the period of time they were in the study. In 96 weeks, in the per-protocol population, the ARR was 0.05 in the peginterferon beta-1a group versus 0.11 in the interferon beta-1a group, which does not reflect a statistically significant difference (p=0.09; 95 % CI, 0.18-1.14). Considering the upper limit of the one-sided 95 % CI of the rate ratio of peginterferon beta-1a compared to interferon beta-1a, as well as the non-inferiority margin, it can be concluded that the primary outcome was met. The results were also comparable for other efficacy and safety outcomes.

CONCLUSION:

The results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients. Both arms were also comparable in other efficacy outcomes and safety profiles with no statistically significant differences. These findings support considering peginterferon beta-1a as a safe and efficient option in patients with RRMS. This study was registered on Iranian Registry of Clinical Trials (IRCT201612306135N8) and clinicaltrials.gov (NCT05242133).

项与干扰素β-1a(Biogen, Inc.) 相关的新闻（医药）

2024-12-18

·GlobeNewswire-Health Care

OSE Immunotherapeutics to Present Anti-IL-7R Lusvertikimab Phase 2 Induction Results in Ulcerative Colitis at 20th Congress of ECCO

A clinical abstract on the induction results from the CoTikiS Phase 2 trial of anti-IL-7 Receptor Lusvertikimab in Ulcerative Colitis accepted for Oral Presentation and selected amongst the Top 10 oral abstracts for 20th Congress of European Crohn’s and Colitis Organization (ECCO) Highlights. Research highlights OSE Immunotherapeutics’ continued commitment to advancing the treatment and management of IBD. NANTES, France, December 18, 2024 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that an abstract related to its first in class anti-IL-7 Receptor (IL-7R) Lusvertikimab, has been accepted for Oral Presentation at the 20th congress of the European Crohn’s and Colitis Organization (ECCO) being held February 19-22, 2025, in Berlin (Germany). Details of the presentation: EC25-1892 - "Lusvertikimab, a first-in-class IL7 receptor antagonist, in moderate to severe Ulcerative Colitis: results of a multicenter, randomized, placebo-controlled phase II study" has been accepted as an Oral Presentation in the Scientific Program and selected amongst the Top 10 oral abstracts for the Congress Highlights of ECCO’25 video. Presentation number: OP36Session name: Sustainability in IBD and beyond - Session 10: Hot topics in IBDSession date: 22/02/25; Session time: 08:30 - 10:50; Presentation time: 10:10 - 10:20Session hall: Plenary Hall / Hall B Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are excited to present for the first time at a congress the clinical efficacy and safety data from the induction study in ulcerative colitis. This prestigious scientific meeting gathers the world’s leading specialists in Inflammatory Bowel Diseases (IBD). Lusvertikimab, a pure interleukin-7 receptor antagonist mAb that exclusively blocks IL-7 boasts a differentiated mechanism of action and a favorable tolerance profile. We believe Lusvertikimab is uniquely positioned in IBD, with potential also for a broader spectrum of chronic inflammatory and autoimmune diseases.” Interleukin-7 (IL-7) produced locally by epithelial cells is a crucial survival factor for pathogenic T lymphocytes residing in tissues, such as colitogenic memory T cells1. Lusvertikimab is a unique antagonist of IL-7R targeting the CD127 receptor, the alpha chain of the IL-7R, with a differentiated mechanism of action allowing a selective inhibition of the IL-7 biology while sparing TSLP (Thymic Stromal LymphoPoietin) cytokine and growth factor. This allows potent inhibition of pathogenic memory and effector T lymphocytes expressing high level of CD127, while promoting regulatory T cells (Tregs) biology expressing low level of CD127. The protective role of TSLP in intestinal immunity has been reproducibly described, in particular to instruct Treg generation against commensal bacteria2 and TSLP inhibition has been reported to exacerbate mucosal inflammation and colitis3. This biology together with the results of the CoTikiS study supports the continued clinical development of a pure IL-7 antagonist in IBD, and other diseases where Tregs and microbiota cross-talks are implicated in tissular healing. Interleukin-7 Receptor (IL-7R) overexpression has been associated with numerous diseases4 and therapeutic areas, with preclinical efficacy already demonstrated in IBD5, rheumatoid arthritis6, neuroinflammation7, airways inflammation8, dermatology9, type 1 diabetes10 and lupus11. ABOUT ULCERATIVE COLITIS (UC)Ulcerative colitis is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. This condition is the result of the immune system’s overactive response. UC affects 3.3 million patients in the US, Europe and Japan (1). Despite broad therapeutic options, remission rates remain only 25-30% (2) leaving most patients without satisfactory treatments. 15% of patients (3) fail to respond to all therapies and undergo surgery as a last option.(1) EvaluatePharma (2) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572(3) Scientific Reports volume 10, Article number: 12546 (2020)ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Fiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comFrench Media Contact FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 Markus F. Neurath, Strategies for targeting cytokines in inflammatory bowel disease, Nat Rev Immunol 20242 I Spadoni et al., Dendritic cells produce TSLP that limits the differentiation of Th17 cells, fosters Treg development, and protects against colitis, Mucosal Immunol, 2012 3 Jonathan L Messerschmidt et al., TSLP/dendritic cell axis promotes CD4+ T cell tolerance to the gut microbiome, JCI Insight, 2023 Betsy C Taylor et al., TSLP regulates intestinal immunity and inflammation in mouse models of helminth infection and colitis, J Exp Med, 20094 Barata, J. T., S. K. Durum, and B. Seddon. 2019. Flip the coin: IL-7 and IL-7R in health and disease. Nat. Immunol. 20: 1584_1593.5 Belarif, L., R. Danger, L. Kermarrec, V. Nerri`ere-Daguin, S. Pengam, T. Durand, C. Mary, E. Kerdreux, V. Gauttier, A. Kucik, et al. 2019. IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease. J. Clin. Invest., 2019.Willis, C. R. et al., Interleukin-7 receptor blockade suppresses adaptive and innate inflammatory responses in experimental colitis. J. Inflamm., 2012.6 Sarita A Y Hartgring, Blockade of the interleukin-7 receptor inhibits collagen-induced arthritis and is associated with reduction of T cell activity and proinflammatory mediators, Arthritis Rheum, 2010Zhenlong Chen, The novel role of IL-7 ligation to IL-7 receptor in myeloid cells of rheumatoid arthritis and collagen-induced arthritis, J Immunol, 2013 7 Li-Fen Lee et al., IL-7 promotes T(H)1 development and serum IL-7 predicts clinical response to interferon-β in multiple sclerosis 8 Hoa Le Mai et al., Targeting the interleukin-7 receptor alpha by an anti-CD127 monoclonal antibody improves allergic airway inflammation in mice, Clin Exp Allergy, 2020 9 Lyssia Belarif et al., IL-7 receptor blockade blunts antigen-specific memory T cell responses and chronic inflammation in primates, Nat Commun, 2018Zhenpeng Dai et al., Blockade of IL-7 signaling suppresses inflammatory responses and reverses alopecia areata in C3H/HeJ mice, Sci Adv, 2021 10 Li-Fen Lee et al., Anti-IL-7 receptor-α reverses established type 1 diabetes in nonobese diabetic mice by modulating effector T-cell function, Proc Natl Acad Sci U S A, 2012 Cristina Penaranda, IL-7 receptor blockade reverses autoimmune diabetes by promoting inhibition of effector/memory T cells, Proc Natl Acad Sci U S A, 201211 Rosana Gonzalez-Quintial et al., Systemic autoimmunity and lymphoproliferation are associated with excess IL-7 and inhibited by IL-7Rα blockade PLoS One, 2011 Attachment EN_241218_ECCO Lusvertikimab

临床2期临床结果免疫疗法

2024-11-09

·药事纵横

6家专注于多发性硬化症治疗的biotech

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。多发性硬化症是中枢神经系统（CNS）的一种慢性疾病。作为一种不可预测的疾病，对人的影响不同，一些多发性硬化症患者可能只有轻微的症状，而另一些患者可能会在大脑与身体其他部位之间的交流中断时失去清晰地看、写、说或走路的能力。以下是六家专注于多发性硬化症的生物技术公司，几家公司和研究人员试图通过不同的方法来治疗多发性硬化症，比如BTK抑制剂、CAR-T疗法、双特异性抗体，甚至干细胞疗法。 Biogen 主要多发性硬化候选药物：BIIB091 Biogen以其在神经科学领域的开创性工作而闻名。40多年来，它一直在发现和开发中枢神经系统疾病的治疗方法，包括多发性硬化、肌萎缩侧索硬化（ALS）、阿尔茨海默病、抑郁症、狼疮和脊髓性肌萎缩（SMA）的治疗方法。至于多发性硬化症，该公司已经有几种已获批准的治疗方法，包括Avonex、Plegridy和Vumerity，这些药物都用于治疗多发性硬化症的复发。此外，在其现有的研发过程中，百健正致力于开发下一代伯顿酪氨酸激酶（BTK）抑制剂，称为BIIB091，用于复发性多发性硬化成人患者。目前正处于开发的第二阶段。 BTK是一种非受体酪氨酸激酶，可调节被认为与多发性硬化发病机制有关的B细胞和髓样细胞的发育和信号传导。BIIB091除对B细胞产生作用外，还对髓系细胞中的BTK产生可逆性抑制作用，因此预计BIIB091与仅B细胞疗法相比具有更多的临床益处，并且可以解决共价BTK抑制剂中观察到的耐药性。 Immunic Therapeutics 主要多发性硬化候选药物：Vidofludimus calcium immunictherapeutics正致力于慢性炎症性和自身免疫性疾病的小分子疗法的开发。其主要候选药物是vidofludimus calcium（IMU-838），目前正在开发用于治疗多发性硬化。 IMU-838通过有效激活称为核受体相关1 （Nurr1）的神经保护转录因子发挥作用，Nurr1与直接的神经保护特性相关，并可能增强患者的潜在获益。IMU-838还抑制二氢乳清酸脱氢酶（DHODH），后者是过度活跃的免疫细胞和病毒感染细胞代谢的关键酶。这一双重作用不仅针对炎症和抗病毒过程，而且还解决了多发性硬化潜在的神经退行性方面，使其从现有疗法中脱颖而出，现有疗法虽然能够控制多发性硬化的复发，但不能阻止患者的残疾随着时间的推移而恶化。数项正在进行的多发性硬化试验正在对IMU-838进行测试，包括复发性多发性硬化的两项3期试验和进展性多发性硬化的支持性2期试验。2023年10月，Immunic报告了2期试验的阳性中期数据，因为有生物标志物证据表明，IMU-838的活性超出了之前观察到的抗炎作用。最终，这进一步加强了它的神经保护潜力。此外，在2024年1月，Immunic宣布了高达2.4亿美元的私募。 Kyverna Therapeutics 主要多发性硬化候选药物：KVY-101 Kyverna Therapeutics公司正致力于开发针对b细胞驱动的自身免疫性疾病患者的细胞疗法。这家多发性硬化症公司拥有靶向CD19的自体和异体CAR化合物，该分子在B淋巴细胞的发育、激活和分化中起着重要作用，旨在减少细胞因子释放，消耗B细胞，提高临床耐受性。其主要候选药物KYV-101目前正在一项2期试验中评估用于治疗多发性硬化以及重症肌无力。今年1月，它被美国食品药品监督管理局（FDA）授予快速通道认定，用于治疗难治性进行性多发性硬化患者。此外，Kyverna在2024年2月通过首次公开发行（IPO）获得了.66亿美元的总收益。 Progentos Therapeutics 几个月前，Progentos Therapeutics才成立，获得了6500万美元的A轮融资，用于推进多发性硬化和其他退行性疾病的治疗。在多发性硬化症等疾病中，残疾是由支持轴突功能和生存的脱髓鞘（即髓鞘受损）引起。在这里，免疫系统攻击髓鞘，导致炎症和神经细胞功能受损。正因为如此，Progentos正在开发一种新型小分子，旨在诱导多发性硬化影响的轴突的髓鞘再生。该公司从麻省理工学院（MIT）的子公司Frequency Therapeutics收购了多发性硬化症项目，后者于2023年与RNA编辑公司Korro Bio进行了反向合并。根据Progentos的说法，当涉及到产生和维持髓磷脂的细胞时，它的分子在动物模型中似乎比以前的方法表现更好。从多发性硬化症公司最近的A轮融资中获得的资金将使其能够通过人体概念验证研究来推进其多发性硬化症项目，并扩大其在其他退行性疾病中的研发渠道。 TG Therapeutics 主要多发性硬化候选药物：ublituximab TG Therapeutics专注于利用b细胞生物学的科学进步为患者开发新的治疗方法，特别专注于开发自身免疫性疾病的治疗方法。该公司于2022年12月宣布，FDA已批准其药物BRIUMVI （ublituximab）用于治疗复发型多发性硬化症患者，包括临床孤立综合征，复发缓解性疾病和活动性继发进行性疾病。此外，在2024年9月，TG Therapeutics报告说，经过5年的BRIUMVI治疗，92%的复发性多发性硬化症患者无残疾进展。 Ublituximab是一种单克隆抗体，靶向表达cd20的b细胞上的一个独特表位。当药物与b细胞结合时，会触发一系列免疫反应，包括抗体依赖性细胞毒性[ADCC]和补体依赖性细胞毒性[CDC]，最终导致细胞破坏。此外，阿妥昔单抗被设计为缺乏抗体上正常表达的某些糖分子，因为去除这些糖分子（称为糖工程的过程）已被证明可增强阿妥昔单抗的效力，特别是在ADCC活性方面。作为与Precision BioSciences合作的一部分，TG Therapeutics还在开发一种名为azer-cel的同种异体CAR-T疗法，用于治疗进展型多发性硬化症。Precision BioSciences发现并授权给TG Therapeutics的这一候选药物最近获得了试验性新药（IND）许可，有望于今年晚些时候开始临床试验。 Zenas BioPharma 主要多发性硬化候选药物：Obexelimab Zenas BioPharma专注于基于免疫学的疗法，目前正致力于开发其主要候选药物obexelimab，用于治疗各种免疫学和炎症疾病，包括多发性硬化。 Obexelimab是一种双功能单克隆抗体，旨在通过与广泛存在于B细胞谱系中的蛋白CD19和FcγRIIb结合来耗竭B细胞。根据该公司的说法，这些靶点的共同参与导致了B细胞活性的抑制。 Zenas BioPharma目前正在一项2期试验中纳入患者，以评估obexelimab治疗复发性多发性硬化患者的疗效和安全性。该公司最近也筹集了可观的资金。2024年5月，该公司宣布在C轮融资中获得2亿美元，9月还宣布了2.25亿美元的IPO。这两轮融资的收益将帮助该公司进一步推进obexelimab的研发。参考资料：各公司官网 -END- 2025CMC-CHINA药博会 • 展位火热预定中！

临床2期细胞疗法免疫疗法临床1期临床3期

2024-11-02

·生物制药小编

渤健AD药销售加速

近日，渤健公布了2024年第三季度财报，该季度总营收24.658亿美元，虽然同比去年下降了3%，但仍超过公司预期。基于本季度业绩表现，渤健上调了2024年全年财务指引，将每股收益预期从之前的每股15.75美元—16.25美元上调至16.10美元—16.60美元，同时公司仍然维持之前2024年营收同比2023年将出现个位数下降的预期。营收方面主要分为产品收入、授权收入以及CMO等收入，其中产品收入17.694亿美元，授权收入4.462亿美元，主要来自其授权于罗氏的CD20单抗Ocrevus。产品收入又分为三大块，多发性硬化症业务、罕见病业务以及仿制药业务。多发性硬化症（MS）业务收入仍是公司最大的收入来源，但与去年同期相比下滑9%，为10.539亿美元。罕见病业务Q3季度营收4.948亿美元，同比增长9.98%，其中脊髓性肌萎缩症药物Spinraza受到竞品的影响持续下滑（15%），销售额为3.814亿美元。仿制药业务近几年来几乎都在原大踏步，Q3季度总营收1.966亿美元，同比略增1.18%。 MS产品收入全面下滑一直以来，多发性硬化症（MS）业务收入都是渤健的收入支柱。自1996年公司首款MS药物Avonex获FDA批准以来，渤健不断推出系列升级产品，逐渐建立起在MS领域的领军地位。巅峰时，MS收入对整个公司营收贡献占比达到80以上%。然而随着仿制药以及同类竞争的加入，近几年MS销售收入不断下滑。2024Q3季度，MS系列产品销售额全面下滑，其中Tecfidera从2.395亿美元降至2.328亿美元，Avonex从2.122亿美元降至176.2亿美元，Tysabri从4.563亿美元降至4.061亿美元。增长缓慢但有盼头经历了首款AD药物Aduhelm的大败之后，同属于Aβ单抗的Leqembi成为了公司营收恢复增长的希望。作为第一个真正意义上获得FDA认可的AD新药，Leqembi的一开始的销售表现依旧没能让满意，在去年AD市场上只有这一款Aβ单抗在市销售的情况下（Aduhelm基本推出市场了），Leqembi总共才卖了1000万美元——远低于市场预期。不过，随着Leqembi的推广面逐渐扩大，今年的销售成绩终于是有所些许起色，2024年第一季度Leqembi销售额为1900万美元，是2023年Q4的近3倍。第二季度4000万美元，第三季度达到了6700万美元，已经超过了分析师们的预期（5000万美元）。目前除了美国之外，Leqembi已在日本（2023年9月）、中国（2024年1月）、韩国（2024年5月）、以色列（2024年7月）、阿拉伯联合酋长国（2024年8月）和英国（2024年8月）等国家获得批准。另外，如果Leqembi静脉注射和皮下注射剂型在明天顺利获批，将进一步助推Leqembi的销售增长。总体而言，尽管在销售爬坡速度上，Leqembi的没有达到预期，但整体的增长趋势是可期的。参考出处： https://www.biospace.com/business/biogen-tops-wall-street-expectations-for-leqembi-inks-molecular-glue-deal https://firstwordpharma.com/story/5908151 https://investors.biogen.com/static-files/7e0c5ba7-737b-4788-b036-2cd4401378b3

财报

100 项与干扰素β-1a(Biogen, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04554	干扰素β-1a(Biogen, Inc.)	L03AB07	DB00060

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
继发进展型多发性硬化	澳大利亚	Biogen Australia Pty Ltd.	2004-05-04
复发性多发性硬化	欧盟	Biogen Netherlands BV	1997-03-13
复发性多发性硬化	冰岛	Biogen Netherlands BV	1997-03-13
复发性多发性硬化	列支敦士登	Biogen Netherlands BV	1997-03-13
复发性多发性硬化	挪威	Biogen Netherlands BV	1997-03-13
多发性硬化症	美国	Biogen, Inc.	1996-05-17

未上市

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
溃疡性结肠炎	临床2期	美国	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	加拿大	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	捷克	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	匈牙利	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	波兰	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	俄罗斯	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	斯洛伐克	Biogen, Inc.	2008-05-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	美国	Biogen, Inc.	2004-02-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	澳大利亚	Biogen, Inc.	2004-02-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	加拿大	Biogen, Inc.	2004-02-01

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临床结果

适应症

分期

评价

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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


NPMSC (AAN2024)	N/A	-	254	Avonex	簾襯壓齋蓋鹹鏇鹽築餘(積鹹簾廠鬱顧鹽顧鹹壓) = 構窪獵築衊餘膚選蓋鹽遞衊積構觸蓋蓋構廠網 (範膚醖艱遞鹽鏇衊繭簾 ) 更多	积极	2024-04-09
				Plegridy	簾襯壓齋蓋鹹鏇鹽築餘(積鹹簾廠鬱顧鹽顧鹹壓) = 鹽艱窪衊膚衊廠鑰窪憲遞衊積構觸蓋蓋構廠網 (範膚醖艱遞鹽鏇衊繭簾 ) 更多
PeMSDD (ACTRIMS2024)	N/A	-	254	Avonex	遞築窪壓顧鑰範窪餘衊(鬱糧窪餘構製鹹夢簾窪) = 衊築醖窪襯遞遞憲餘窪遞積鹽積製鬱蓋鏇獵膚 (醖膚艱餘淵蓋壓鏇膚顧 ) 更多	积极	2024-03-01
				Plegridy	遞築窪壓顧鑰範窪餘衊(鬱糧窪餘構製鹹夢簾窪) = 襯壓鬱鬱範膚襯襯鏇糧遞積鹽積製鬱蓋鏇獵膚 (醖膚艱餘淵蓋壓鏇膚顧 ) 更多
ACTRIMS2023	N/A	多发性硬化症	-	Interferon beta-1a	顧觸鹹獵齋網窪遞醖鹹(範顧夢網簾繭繭艱鏇廠) = congestive heart failure 膚範願鹽築衊齋廠齋憲 (鹽顧獵築簾壓窪窪糧製 ) 更多	不佳	2023-05-30
AAN2022	N/A	多发性硬化症	-	Subcutaneous Interferon β-1a	選簾網鬱簾襯齋網窪範(蓋選鏇夢窪簾糧憲鬱齋) = the majority were non-serious events. Among confirmed cases (n=1029), 110 patients were hospitalized with 5 requiring mechanical ventilation. There were 24 fatalities (18 fatal COVID-19 events and 6 other fatalities unconfirmed for COVID-19 involvement). At time of reporting, around half of COVID-19 confirmed AEs were recovered or resolving. 憲鹽壓觸鏇選廠艱衊構 (積網遞糧簾簾蓋簾襯鏇 ) 更多	-	2022-05-03
REFLEX/ION study (ECTRIMS2021)	N/A	脱髓鞘疾病	392	Early treatment with subcutaneous interferon beta-1a	顧願遞願齋夢遞鏇獵鹽(醖鹹鏇蓋淵齋獵遞衊構) = 觸繭築網蓋壓鹹壓網選窪淵壓範窪壓鹹餘蓋鹹 (蓋鹹築夢築壓願鑰鬱簾 ) 更多	-	2021-10-12
				Delayed treatment with subcutaneous interferon beta-1a	顧願遞願齋夢遞鏇獵鹽(醖鹹鏇蓋淵齋獵遞衊構) = 衊壓齋艱網艱構廠遞鏇窪淵壓範窪壓鹹餘蓋鹹 (蓋鹹築夢築壓願鑰鬱簾 ) 更多
ACTRIMS2021	N/A	多发性硬化症	-	Subcutaneous Interferon Î²-1a	鑰築鏇繭齋簾繭夢襯糧(構範鹹淵蓋築壓願餘觸) = Cumulative to August 4, 2020, there was no increased risk of COVID-19 in sc IFN Î²-1a-treated patients with RMS and cases were relatively mild, consistent with previously reported registries. 構積鏇網製醖艱膚鹹廠 (範齋積願願夢憲壓齋壓 ) 更多	积极	2021-07-01
ECTRIMS2020	N/A	多发性硬化症	-	subcutaneous interferon beta-1a (18-30 years)	網鹹選廠顧製憲鹽窪觸(壓積願壓鑰艱簾範糧繭) = 鏇構蓋鏇醖襯蓋網夢醖夢遞鹽範憲艱蓋顧築餘 (繭範範齋範製網鏇夢築, 0.16 ~ 0.34) 更多	-	2020-12-07
				subcutaneous interferon beta-1a (31-40 years)	-
ECTRIMS2020	N/A	多发性硬化症	-	Subcutaneous interferon β-1a	衊鬱繭衊範淵繭壓廠糧(構窪獵網壓餘鑰築網餘) = 23 cases of confirmed COVID-19 in sc IFN β-1a treated MS patients 壓願夢憲製鹽艱構鏇範 (艱餘襯網衊鹽簾窪夢繭 ) 更多	积极	2020-12-07
REFLEX (AAN2020)	临床3期	脱髓鞘疾病一线 cerebrospinal fluid specific oligoclonal bands \| symptomatic lesions \| cortical lesions	517	scIFNβ-1a three times (tiw)	遞網製鬱製鹽襯顧構鬱(艱廠積鹹獵構鑰鹽繭醖) = 衊獵鏇蓋蓋壓觸窪淵憲築鬱糧糧鹹鏇繭壓鹹遞 (艱衊艱鬱窪廠鏇廠鑰淵 )	积极	2020-04-14
				scIFNβ-1a once weekly (qw)	遞網製鬱製鹽襯顧構鬱(艱廠積鹹獵構鑰鹽繭醖) = 積鹽艱夢鬱鏇築鹽鑰範築鬱糧糧鹹鏇繭壓鹹遞 (艱衊艱鬱窪廠鏇廠鑰淵 )
ECTRIMS2019	N/A	多发性硬化症 IFNα	25	IFNβ1a-treated RR-MS patients	範衊構壓築衊窪構鑰衊(願衊獵艱鬱遞鏇觸製範) = 壓鏇遞觸廠選蓋蓋艱選襯糧衊蓋廠觸願蓋網齋 (糧觸淵蓋鑰壓積壓廠膚 )	-	2019-09-10