A Single Center, Single Dose, Open-label Study in Healthy Japanese Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Otilimab

This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.

开始日期2023-02-08

申办/合作机构

GSK Plc

CTR20220414 / Terminated临床3期

试验专业题目一项评估使用GSK3196165治疗类风湿性关节炎的安全性和疗效的多中心、长期扩展研究

主要目的：确定中度至重度活动性类风湿性关节炎（RA）受试者接受GSK3196165 90 mg或150 mg每周一次治疗的长期安全性。次要目的：确定GSK3196165的长期疗效。测定GSK3196165对患者报告结局（PRO）的影响。确定GSK3196165的潜在免疫原性。探索性目的：确定GSK3196165对资格确认研究中接受sarilumab或托法替布治疗的受试者的疗效。确定药代动力学（PK）和靶点结合（TE）。确定停止背景MTX/csDMARD治疗的受试者亚群的疗效、安全性和PK。

开始日期2022-03-30

申办/合作机构

葛兰素史克（中国）投资有限公司

[+2]

JPRN-jRCT2071210132 / Completed临床1期

A single center, single dose, open-label study in healthy Japanese participants to evaluate the safety, tolerability, and pharmacokinetics of otilimab.

开始日期2022-03-23

申办/合作机构-

100 项与奥替利单抗相关的临床结果

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100 项与奥替利单抗相关的专利（医药）

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项与奥替利单抗相关的文献（医药）

2023-12-01·Annals of the rheumatic diseases

Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2)

Article

作者: Wang, Reena ; Gupta, Anubha ; McInnes, Iain B ; O'Shea, Ciara ; Watts, Sarah ; Strand, Vibeke ; Brooks, David ; Shelton, Celia ; Saurigny, Didier ; van der Heijde, Désirée ; Taylor, Peter C ; Goode, Christopher ; Weinblatt, Michael E ; Mukherjee, Sumanta ; Wang, Millie ; Smith, Julia E ; Fleischmann, Roy M ; Takeuchi, Tsutomu ; Davies, John ; Bracher, Marguerite ; Atsumi, Tatsuya ; Schifano, Lorrie A

Objectives:

To investigate the efficacy and safety of otilimab, an antigranulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis.

Methods:

Two phase 3, double-blind randomised controlled trials including patients with inadequate responses to methotrexate (contRAst 1) or conventional synthetic/biologic disease-modifying antirheumatic drugs (cs/bDMARDs; contRAst 2). Patients received background csDMARDs. Through a testing hierarchy, subcutaneous otilimab (90/150 mg once weekly) was compared with placebo for week 12 endpoints (after which, patients receiving placebo switched to active interventions) or oral tofacitinib (5 mg two times per day) for week 24 endpoints. Primary endpoint: proportion of patients achieving an American College of Rheumatology response ≥20% (ACR20) at week 12.

Results:

The intention-to-treat populations comprised 1537 (contRAst 1) and 1625 (contRAst 2) patients. Primary endpoint: proportions of ACR20 responders were statistically significantly greater with otilimab 90 mg and 150 mg vs placebo in contRAst 1 (54.7% (p=0.0023) and 50.9% (p=0.0362) vs 41.7%) and contRAst 2 (54.9% (p<0.0001) and 54.5% (p<0.0001) vs 32.5%). Secondary endpoints: in both trials, compared with placebo, otilimab increased the proportion of Clinical Disease Activity Index (CDAI) low disease activity (LDA) responders (not significant for otilimab 150 mg in contRAst 1), and reduced Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Benefits with tofacitinib were consistently greater than with otilimab across multiple endpoints. Safety outcomes were similar across treatment groups.

Conclusions:

Although otilimab demonstrated superiority to placebo in ACR20, CDAI LDA and HAQ-DI, improved symptoms, and had an acceptable safety profile, it was inferior to tofacitinib.

Trial registration numbers:

NCT03980483,NCT03970837.

2023-12-01·Annals of the rheumatic diseases

Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3)

Article

作者: Gupta, Anubha ; Bracher, Marguerite ; Watts, Sarah ; Strand, Vibeke ; Brooks, David ; Shelton, Celia ; Saurigny, Didier ; Goode, Christopher ; Mukherjee, Sumanta ; Wang, Millie ; Smith, Julia E ; Taylor, Peter C ; O'Shea, Ciara ; Takeuchi, Tsutomu ; Wang, Reena ; Atsumi, Tatsuya ; Fleischmann, Roy M ; Weinblatt, Michael E ; McInnes, Iain B ; Davies, John ; Schifano, Lorrie A

Objectives:

To investigate the efficacy and safety of otilimab, an anti-granulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis and an inadequate response to conventional synthetic (cs) and biologic disease-modifying antirheumatic drugs (DMARDs) and/or Janus kinase inhibitors.

Methods:

ContRAst 3 was a 24-week, phase III, multicentre, randomised controlled trial. Patients received subcutaneous otilimab (90/150 mg once weekly), subcutaneous sarilumab (200 mg every 2 weeks) or placebo for 12 weeks, in addition to csDMARDs. Patients receiving placebo were switched to active interventions at week 12 and treatment continued to week 24. The primary end point was the proportion of patients achieving an American College of Rheumatology ≥20% response (ACR20) at week 12.

Results:

Overall, 549 patients received treatment. At week 12, there was no significant difference in the proportion of ACR20 responders with otilimab 90 mg and 150 mg versus placebo (45% (p=0.2868) and 51% (p=0.0596) vs 38%, respectively). There were no significant differences in Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, pain Visual Analogue Scale or Functional Assessment of Chronic Illness Therapy-Fatigue scores with otilimab versus placebo at week 12. Sarilumab demonstrated superiority to otilimab in ACR20 response and secondary end points. The incidence of adverse or serious adverse events was similar across treatment groups.

Conclusions:

Otilimab demonstrated an acceptable safety profile but failed to achieve the primary end point of ACR20 and improve secondary end points versus placebo or demonstrate non-inferiority to sarilumab in this patient population.

Trial registration number:

NCT04134728.

2023-02-01·The European respiratory journal

A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR)

Article

作者: Hatlen, Timothy ; Kostina, Natalia ; Colombo, Hugo ; Bass, Damon ; Terzi, Nicolas ; Criner, Gerard J ; Gupta, Anubha ; Trefilova, Yuliya ; Smith, Julia E ; Jarvis, Emily ; Mukherjee, Sumanta ; de-Miguel-Díez, Javier ; Doreski, Pablo A ; Lakshminarayanan, Divya ; Summers, Charlotte ; Schifano, Lorrie ; Neisen, Jessica ; Sprinz, Eduardo ; O'Shea, Ciara ; Tidswell, Mark A ; Wyncoll, Duncan ; Muñoz-Bermúdez, Rosana ; Shirano, Michinori ; Boughanmi, Hatem ; Martinez-Ayala, Pedro ; Kropotina, Tatiana ; McEvoy, Charlene ; Patel, Jatin ; Lacherade, Jean-Claude ; Schwab, Lee E ; Bocca Ruiz, Xavier ; Meziani, Ferhat ; Hanrott, Kate ; Isaacs, John D ; Layton, Mark ; Beishuizen, Albertus ; Williamson, Russell ; Plantefeve, Gaëtan ; Davy, Katherine ; Shahid, Zainab ; Fernandes, Sofia ; Inman, Dave ; Monchi, Mehran ; Cahn, Anthony ; François, Bruno

Background:

Granulocyte–macrophage colony-stimulating factor (GM-CSF) and dysregulated myeloid cell responses are implicated in the pathophysiology and severity of COVID-19.

Methods:

In this randomised, sequential, multicentre, placebo-controlled, double-blind study, adults aged 18–79 years (Part 1) or ≥70 years (Part 2) with severe COVID-19, respiratory failure and systemic inflammation (elevated C-reactive protein/ferritin) received a single intravenous infusion of otilimab 90 mg (human anti-GM-CSF monoclonal antibody) plus standard care (NCT04376684). The primary outcome was the proportion of patients alive and free of respiratory failure at Day 28.

Results:

In Part 1 (n=806 randomised 1:1 otilimab:placebo), 71% of otilimab-treated patients were alive and free of respiratory failure at Day 28versus67% who received placebo; the model-adjusted difference of 5.3% was not statistically significant (95% CI −0.8–11.4%, p=0.09). A nominally significant model-adjusted difference of 19.1% (95% CI 5.2–33.1%, p=0.009) was observed in the predefined 70–79 years subgroup, but this was not confirmed in Part 2 (n=350 randomised) where the model-adjusted difference was 0.9% (95% CI −9.3–11.2%, p=0.86). Compared with placebo, otilimab resulted in lower serum concentrations of key inflammatory markers, including the putative pharmacodynamic biomarker CC chemokine ligand 17, indicative of GM-CSF pathway blockade. Adverse events were comparable between groups and consistent with severe COVID-19.

Conclusions:

There was no significant difference in the proportion of patients alive and free of respiratory failure at Day 28. However, despite the lack of clinical benefit, a reduction in inflammatory markers was observed with otilimab, in addition to an acceptable safety profile.

项与奥替利单抗相关的新闻（医药）

2024-01-10

·FiercePharma

JPM24, Day 2: Lilly CEO says competition benefits obesity field; Novavax readies phase 3 combo trial

The J.P. Morgan Healthcare Conference rolled on Tuesday with corporate updates from Eli Lilly and other companies. As the J.P. Morgan Healthcare Conference rolls on in San Francisco, BioNTech, Alnylam, and many other companies updated investors on their businesses heading into 2024. We'll update this page throughout the day; be sure to check back regularly. Tuesday, Jan. 9 at 8:30 p.m. ET AstraZeneca laid out its lofty goals for the end of the decade, which include not only delivering “industry-leading growth” by 2030, but placing in at least “the top-three position” in its five focus areas, chief financial officer Aradhana Sarin said during the company’s presentation. That means AZ is looking to be a top player in oncology, rare diseases, vaccines/immunotherapies, respiratory diseases/immunology plus the field of cardiovascular, renal and metabolism. With a wide geographic footprint and a vast pipeline contributing to “strong growth potential,” the company calls its growth profile “relatively de-risked” compared to peers. As for a more short-term goal, the drugmaker is targeting double-digit growth from 2021 to 2025, a rate that it is “very much on track” to achieve, Sarin said. Even more important than the numbers is the “confidence we have in delivering that growth ambition,” the CFO said. That confidence is backed by the company’s existing products and new indications, plus the previously divulged plan of launching 15 meds by 2030. Release Tuesday, Jan. 9 at 8:09 p.m. ET Novavax is in discussions with Walgreens to add the company's COVID-19 vaccine to the pharmacy's stores for the 2024-25 season, company executives told Fierce Pharma on the sidelines of this year's J.P. Morgan Healthcare Conference. The chain pharmacy elected not to carry the vaccine this season, sticking only with the mRNA options. Meanwhile, Novavax is in the latter half of its first full COVID vaccination season in the U.S., joining Moderna and Pfizer, though its shot remains under emergency use authorization. The Maryland vaccine maker expects that to change, however, with FDA approval tentatively planned for the end of August or early September, according to Chief Operating Officer John Trizzino New CEO John Jacobs is finally coming up for air after a year marked by significant cuts to administrative, manufacturing and R&D costs. The company disclosed that a second round of "focused headcount reductions" would be included in the most recent $300 million cost-cutting plan, announced in November. But he's bullish now, saying the company has $2 billion in cash that's "virtually guaranteed" when considering cash on hand, government contracts and existing receivables. Novavax reported having $666 million in cash as of the end of September 2023. Jacobs says that's enough for the company to solo develop its COVID-flu combination vaccine, slated for a phase 3 trial in humans this year. UPDATED: Tuesday, Jan. 9 at 6:19 p.m. ET Eli Lilly CEO David Ricks threw credit to Novo Nordisk for pursuing GLP-1s for obesity during his Tuesday presentation: “We have tremendous respect for Novo Nordisk and have competed with them for like 100 years and know each other pretty well. “I think here's a case where probably competition spurs us both on to go faster and build out more indications and really take the insight—which, credit to Novo, was to exploit high dose GLPs to pursue weight loss, noticing the separation between A1C and weight loss at the higher doses and we're following them and driving that and I think the world would benefit from that.” The obesity market lends itself to more involvement given the massive demand. Ricks said the two companies are not fighting over a “fixed pie,” but instead using their combined powers to advance the GLP-1 field into addressing other health challenges such as cardiovascular risks, sleep apnea and so on. Ricks said that Novo is the first competitor Lilly thinks about, but another potential threat is the number of larger companies buying into obesity using M&A. “If you're sitting in a boardroom of a large drug company, you're probably asking the CEO, like where's our obesity program? So they're getting one,” Ricks said with a laugh. “Some of them will succeed. Some won't.” First-mover advantage is often crucial in the pharma industry and obesity is no different, especially given the manufacturing scale needed to make a difference in the space, according to Ricks. New entrants will need to push hard on the additional health benefits of their medicines beyond obesity, he added. “We should take them all seriously, and I think sometimes competition discovers new things that we didn't think of, and that's good,” Ricks said. “There is a huge addressable market here. So I'm not saying it'll be two companies that find it all. But probably the benefit of time and experience with this platform really lends to us and a Danish company.” UPDATED: Tuesday, Jan. 9 at 5:40 p.m. ET After more than 25 years in the field, Novo Nordisk has largely proved its obesity thesis, CEO Lars Fruergaard Jørgensen said Tuesday at the J.P. Morgan Healthcare Conference. But even as the potentially multi-billion-dollar market opens up, “we are just getting going,” the CEO said. Not long after Wegovy’s obesity launch, demand outstripped supply, with that inventory uncertainty persisting through 2023. As for the coming year, “I’m very comfortable looking into 2024—and specifically for Wegovy in the U.S.—that we can add significant additional volumes,” Jørgensen explained. That additional capacity for 2024 didn’t come all at once, either, the CEO pointed out. “This is a continued journey of building capacity for the years to come,” Jørgensen said. UPDATED: Tuesday, Jan. 9 at 5:30 p.m. ET GSK expects that Nucala could see around £500 million to £1 billion in additional peak sales in chronic obstructive pulmonary disease (COPD) if a phase 3 readout expected in the second half of 2024 turns out positive, CEO Emma Walmsley said Tuesday. Previously, Nucala’s direct rival, AstraZeneca’s Fasenra, failed two COPD trials. Meanwhile, GSK’s Nucala follow-on candidate, the long-acting IL-5 antibody depemokimab, should deliver phase 3 data in the first half of this year. Walmsley put that drug’s peak sales potential at more than £3 billion. That’s much more than the £1 billion to £2 billion range that the company put out during an investor update in mid-2021. Compared with the 2021 update, the anti-GM-CSF antibody otilimab has lost its place in GSK’s immunology portfolio after disappointing phase 3 results led to its discontinuation in 2022. Taking its place is camlipixant, a chonic cough program that GSK got last year from its $2 billion acquisition of Bellus Health. After the FDA's recent complete response letter for Merck’s rival med gefapixant, GSK believes camlipixant could generate more than £2.5 billion in peak sales. The drug’s phase 3 program is on track to report results in the second half of 2025. UPDATED: Tuesday, Jan. 9 at 4:55 p.m. ET Four years after the arrival of the company’s CEO Paul Hudson, the “new” Sanofi has finally started to take shape. With the goal to become a tech-powered, immunology powerhouse, Sanofi is now in the midst of a “real moment,” Hudson said Tuesday at the J.P. Morgan Healthcare Conference in San Francisco. “It’s been a long time in the making, and we really feel like we’re demonstrating that we’re the new Sanofi,” he said. Much of the company’s momentum will continue to hinge on its Regeneron-partnered megablockbuster Dupixent, which Hudson expects to reel in roughly 13 billion euros in sales in 2024. But while Dupixent will continue to grow “until its end,” Hudson knows the medicine’s patent cliff is looming sometime during the next decade. In turn, Sanofi is going all-in on R&D, with the goal to generate more than 10 billion euros in sales from new medicines by 2030. “This is a very important moment for the company to have multiple shots on goal in massive diseases,” Hudson said. “This is a deck stacked for success.” After declines for its hematology franchise earlier in the decade, Roche is riding the rebound. The company's hemophilia A blockbuster Hemlibra is providing much of the sales firepower, but newer T-cell engagers Lunsumio and Columvi are giving Roche more reasons for optimism. Those two meds are off to strong starts, and Roche is running studies to potentially move them into earlier treatment lines. Also in Roche's hematology portfolio is the lucrative antibody-drug conjugate Polivy. In all, Roche sees its blood-cancer franchise delivering 14% average annual growth through 2026, following sizable sales declines in 2020 and 2021. Story UPDATED: Tuesday, Jan. 9 at 3:37 p.m. ET While 2024 will be “monumental” for Sarepta Therapeutics, the company’s ambitions extend to 2030, when it’s poised to “become a big biotech,” CEO Doug Ingram said at the conference. Last year, the biotech scored an accelerated approval for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys under a restricted label. Now, Sarepta hopes to expand the approved usage to cover all DMD patients. Despite missing the primary endpoint in a key trial, the company maintains its belief that the data “exceeded the threshold for substantial evidence of effectiveness,” Ingram said. Meanwhile, the FDA is “committed to evaluating a labeling expansion to the fullest extent possible,” according to the CEO’s presentation. The treatment brought in an estimated $200 million in 2023 after its June approval. Mizuho analysts called the sales estimate “better than expected” and believe the “odds are high” for the potential label expansion. Sarepta projected its total 2023 revenue to come in at $945 million, exceeding its previous guidance. Release UPDATED: Tuesday, Jan. 9 at 10:45 a.m. ET After its overwhelming success during the pandemic, Pfizer was knocked down a peg in 2023. Its launches came up short and the company was blindsided by a sudden drop in demand for its pandemic products. After some retooling, the company is set for a “year of execution,” Pfizer CEO Albert Bourla said. “We used to be the stars of the industry for a few years, so the drop really hurts.” The silver lining for the company in 2023 was a record nine FDA approvals for novel products, including two for Abrysvo, though the company has some regrets about the early performance of its RSV vaccine launch. Story The new year brings Merck closer to 2028 when the company will lose patent protection for mega-blockbuster Keytruda. At the J.P. Morgan Healthcare Conference, CEO Rob Davis tried to de-emphasize the impact of the Keytruda cliff by focusing on the company’s pipeline assets, including three antibody-drug conjugates that Merck has in-licensed from Daiichi Sankyo and a Moderna-partnered cancer vaccine. Last January, Merck said its pipeline of oncology prospects could eventually produce $10 billion annually. A year later, Merck has jacked up its oncology portfolio estimate to $20 billion-plus by the middle of the next decade. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. It’s just another year.” Story UPDATED: Tuesday, Jan. 9 at 10:36 a.m. ET As COVID vaccine revenues sink across the board, mRNA specialist BioNTech is turning its attention to its oncology pipeline. This year pledges to be one of “significant execution,” CEO and co-founder Ugur Sahin, M.D., said in a strategic update. The company projects revenues of approximately €3 billion ($3.28 billion) for 2024, mainly driven by its Pfizer-partnered COVID vaccine Comirnaty, which is expected to “remain profitable.” That would be a drop from last year, given that BioNTech has guided for 2023 COVID-19 vaccine sales of €4 billion. Also last year, BioNTech added six new prospects to its oncology pipeline, which now includes a mix of phase 2 and phase 3 assets. Outside of cancer therapies, the company is working on an mRNA-based combination COVID and influenza vaccine alongside Pfizer. BioNTech’s full corporate update will take place later today at 12 p.m. ET. Release Alnylam collected revenues of $1.24 billion in 2023 thanks to its polyneuropathy of hATTR amyloidosis meds Onpattro and Amvuttra, plus its hepatic porphyria therapy Givlaari and primary hyperoxaluria type 1 treatment Oxlumo. The company’s ATTR franchise garnered $913 million, while the two ultra-rare drugs pulled a total of $329 million. Total revenues from Alnylam’s portfolio were up 39% from 2022. The company believes it is on the way toward positioning itself as a “top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry,” CEO Yvonne Greenstreet said in a statement. The RNAi drugmaker will report results from its phase 3 study of its vutrisiran in cardiomyopathy of ATTR amyloidosis early this year. Alnylam will further discuss its financial results and commercial updates at the J.P. Morgan Healthcare Conference today during its presentation at 12:45 p.m. ET. Release

疫苗临床3期

2023-03-03

·佰傲谷BioValley

大型Biotech的挣扎求生丨砍去临床前管线，并裁员17%

昨日（3月2日），MorphoSys AG宣布将裁撤该公司的临床前管线，并裁去其在德国总部Planegg的17%的员工，届时将有总计110名员工失业。该公司在新闻稿内宣布虽然其临床前项目前景还不错，但它表示需要更多资金才能进入临床，并为此筹集资金在目前的环境下说起来容易，做起来难。而此次裁撤则将让MorphoSys得以将资源更好地集中在目前的肿瘤临床管线上。事实上，MorphoSys作为德国前五大Biotech，在2021年创下德国最大生物科技企业最大并购案之后，一直在走下坡路。根据该公司的第三季度财报展示，该公司至少有三大隐患，这使得这一裁撤早有先兆。两大合作项目接连失败首先，MorphoSys AG其实此前和美国药品特许权投资公司Royalty Pharma建立了长期战略融资合作伙伴关系。Royalty Pharma的模式是对管线而非公司进行对赌，因此双方的合作基于MorphoSys AG方面的几个临床项目。MorphoSys AG能获得Royalty Pharma的里程碑付款，而Royalty Pharma可以从MorphoSys AG的管线 otilimab、gantenerumab和pelabresib中获得特许权使用费等费用。但可惜的是，除了还在进行的pelabresib，其他都遭遇了失败。而在去年10月的时候MorphoSys AG的合作伙伴葛兰素史克(GSK)完全放弃了开发GM-CSF单抗 otilimab——无论是类风湿性关节炎还是备受瞩目的新冠肺炎。此外，与罗氏合作的Aβ单抗gantenerumab也因为临床未达终点而停止后续开发，因此这使得Royalty Pharma和MorphoSys AG都蒙受了损失。现金流赛道危急而另外一个值得关注的问题可能，是MorphoSys AG的现金流赛道，从第三季度财报来看，该公司的目前现金和其他金融资产为10.381亿欧元，而去年仅仅前三季度事实上已经产生了4.805亿欧元的净亏损，远大于2021年的1.335亿欧元。如果按照2022年的消耗速度，恐怕只用一年MorphoSys AG的现金流赛道就将枯竭。而根据第三季度财报MorphoSys AG自己的陈述，2022年里程碑不会带来任何显著的现金增值收入，这使得第四季度的预测可能向着更糟糕的方向踩下油门。CD19单抗比不过CD19-CAR-T第三个问题则是目前的产品如何确保销售额持续增长上，tafasitamab是目前该公司上市的唯一产品，是一款靶向CD19的人源化单克隆抗体，最初MorphoSys从Xencor公司获得，后来由Incyte和MorphoSys共同商业化（国内的商业合作伙伴则是诺诚健华），在欧美被批准用于与来那度胺联用治疗复发/难治性弥漫性大B细胞淋巴瘤。（下图为Incyte和MorphoSys的具体分摊方式）看到CD19这个靶点以及弥漫性大B细胞淋巴瘤（DLBCL）可能会让人想到CD19-CAR-T，如果单从临床数据来看，联合疗法的临床数据57.5%/40% ORR/CR虽然不错，但在CD19-CAR-T人均70%以上的ORR和50%的CR的时代，这一数据可能不够看。虽然也有人认为tafasitamab是不适合CAR-T患者的一种选择，但这一人群群体的数量能有多大仍然需要调查。此外，tafasitamab的年花费对于患者来说负担也过高，一般而言患者每年要花费19.8万美元去负担tafasitamab，负担2年就堪比一次的CAR-T了，既然这样，那为什么不选择CD19-CAR-T呢？而从数据来看，虽说tafasitamab的销售额从去年前三季度的4.64亿欧元增加到了6.02亿欧元，涨幅达到了30%，但对于CAR-T来说，同样的涨幅可能就达到了67%，而销售额方面也是CAR-T完胜。（吉利德Yescarta全年涨幅）小编总结从目前已知的信息来看，在其他两项管线已经失利的情况下，Pelabresib的成功与否对于MorphoSys来说至关重要，这是确保在tafasitamab之外获得现金流的重要手段，因此不得不裁撤临床前项目，是MorphoSys生存下去的关键。参考来源：https://www.morphosys.com/en/news/morphosys-ag-reports-first-nine-months-and-third-quarter-2022-financial-results迷茫的GM-CSF单抗https://en.wikipedia.org/wiki/TafasitamabSalvatore Perrone, Paolo Lopedote, Mario Levis, Alice Di Rocco & Stephen Douglas Smith (2022) Management of relapsed or refractory large B-cell lymphoma in patients ineligible for CAR-T cell therapy, Expert Review of Hematology, 15:3, 215-232, DOI: 10.1080/17474086.2022.2044778注：本文不具有任何投资和医学建议近期热门视频更多精彩视频，尽在佰傲谷视频号，欢迎关注~本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀点亮在看，传递信息♥

财报免疫疗法细胞疗法并购

2023-01-09

·PRNewswire

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床结果

100 项与奥替利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11343	-	-	DB06303

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
类风湿关节炎	临床3期	阿根廷	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	巴西	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	加拿大	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	捷克	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	匈牙利	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	印度	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	意大利	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	墨西哥	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	菲律宾	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	波兰	葛兰素史克（中国）投资有限公司	2019-05-16

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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


NCT04333147 (CTgov)	临床3期	类风湿关节炎	2,916	csDMARD(s)+Otilimab (GSK3196165) (Otilimab 90 mg)	窪鹹廠廠艱構選顧醖壓(願襯廠醖餘製鹽顧襯鹹) = 糧獵網觸觸蓋網壓觸築願簾憲廠淵繭築淵糧糧 (夢夢蓋廠鬱獵範蓋願餘, 鏇蓋繭築膚顧襯襯觸憲 ~ 選淵醖襯膚憲餘壓糧鏇) 更多	-	2024-02-07
				csDMARD(s)+Otilimab (GSK3196165) (Otilimab 150 mg)	窪鹹廠廠艱構選顧醖壓(願襯廠醖餘製鹽顧襯鹹) = 衊繭糧範鑰獵壓壓鏇觸願簾憲廠淵繭築淵糧糧 (夢夢蓋廠鬱獵範蓋願餘, 範積壓製齋膚範網壓觸 ~ 網糧夢鑰蓋製衊範構願) 更多
NCT03980483 (CTgov)	临床3期	类风湿关节炎	1,537	GSK3196165 (Otilimab) (GSK3196165 90mg + MTX)	衊繭構夢糧願選憲獵廠(襯築獵膚淵膚觸夢窪觸) = 齋糧餘蓋網獵顧製糧廠淵獵願顧鬱蓋選衊壓蓋 (選窪構糧積壓簾獵積蓋, 獵築淵淵醖鹹醖獵築鑰 ~ 夢齋鏇鏇艱鏇積鏇膚淵) 更多	-	2023-10-25
				GSK3196165 (Otilimab) (GSK3196165 150mg + MTX)	衊繭構夢糧願選憲獵廠(襯築獵膚淵膚觸夢窪觸) = 餘構顧築鏇醖蓋蓋壓醖淵獵願顧鬱蓋選衊壓蓋 (選窪構糧積壓簾獵積蓋, 繭築窪襯蓋積淵願衊鹹 ~ 網壓遞蓋範願齋網遞鏇) 更多
NCT04134728 (ContRAst-3, CTgov)	临床3期	类风湿关节炎	550	csDMARD+GSK3196165 (GSK3196165 90mg + csDMARD)	膚糧蓋鏇觸夢艱艱餘鏇(衊鏇艱餘顧膚淵壓夢窪) = 範膚獵艱製鑰鬱鏇壓膚糧構願繭積繭襯憲鹽繭 (鹹淵淵餘積簾鹽築衊蓋, 鹽壓願選積鑰簾鹽築鹽 ~ 繭鏇壓鑰糧築鹽構艱鹽) 更多	-	2023-07-17
				csDMARD+GSK3196165 (GSK3196165 150mg + csDMARD)	膚糧蓋鏇觸夢艱艱餘鏇(衊鏇艱餘顧膚淵壓夢窪) = 憲顧衊積壓範製遞鏇鹽糧構願繭積繭襯憲鹽繭 (鹹淵淵餘積簾鹽築衊蓋, 夢繭製選夢築鑰醖繭壓 ~ 壓蓋艱遞壓憲蓋夢壓艱) 更多
NCT03970837 (contRAst 2, Corporate Publications) 人工标引	临床3期	类风湿关节炎	-	Otilimab	壓鹹製選繭餘製範積醖(淵積選膚選衊壓膚願襯) = the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 窪選鑰範繭衊繭蓋糧範 (鑰醖廠願獵淵廠衊遞壓 )	积极	2022-10-27
NCT04134728 (ContRAst-3, Corporate Publications) 人工标引	临床3期	类风湿关节炎	-	otilimab	衊選醖顧憲願襯醖鑰淵(鑰鹽構遞顧鑰鑰淵積觸) = the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors. 廠衊鹹鹹鑰鑰觸廠繭鏇 (艱構範襯廠願選繭願糧 )	不佳	2022-10-27
				Placebo
NCT04376684 (CTgov)	临床2期	严重急性呼吸综合征	1,156	placebo+sodium chloride (Part 1: Placebo 1)	遞壓範構齋鹽鹽簾簾廠(衊憲壓製壓遞鬱齋齋網) = 網積顧觸繭積鑰憲壓鹽齋餘壓壓壓餘築範憲簾 (襯遞壓顧鏇憲選願壓獵, 廠鬱糧艱齋壓繭構繭繭 ~ 廠願鑰顧鹹選糧鏇積鹹) 更多	-	2022-03-09
				Otilimab (Part 1: Otilimab 90 mg)	遞壓範構齋鹽鹽簾簾廠(衊憲壓製壓遞鬱齋齋網) = 簾廠積衊蓋築膚鹹願夢齋餘壓壓壓餘築範憲簾 (襯遞壓顧鏇憲選願壓獵, 繭選遞壓積夢獵鬱鹽淵 ~ 獵醖築網獵鏇築選網簾) 更多
NCT02504671 (BAROQUE, ACR2019)	临床2期	类风湿关节炎	222	Otilimab 90 mg	鹽淵餘齋構製窪積鏇醖(餘簾鹽齋遞鹹壓簾繭鑰) = 鹽積繭鹹糧選鹽糧鑰憲蓋網廠築製餘鑰壓壓齋 (構網製範淵壓獵窪襯夢 ) 更多	积极	2019-11-10
				Otilimab 180 mg	鹹鑰獵蓋襯鬱餘壓鹹築(繭製觸簾餘夢範範構鑰) = 簾憲遞繭壓壓鏇獵繭餘壓夢夢壓鏇餘醖選鏇願 (選膚遞膚廠糧製構淵構, 22% ~ 69%) 更多
NCT03028467 (CTgov)	临床1/2期	类风湿关节炎	15	Placebo+Folic acid+Methotrexate	夢艱簾膚範顧網築壓艱(齋積齋範膚繭遞簾簾遞) = 衊觸顧壓餘鹽艱願構膚築艱淵積遞願積網餘鏇 (衊選鹹壓選鑰餘鑰簾淵, 積積窪夢遞繭窪遞艱遞 ~ 鏇窪醖夢構廠範獵夢獵) 更多	-	2019-06-26
NCT02504671 (BAROQUE \| phase IIb dose-finding study, CTgov)	临床2期	类风湿关节炎	222	placebo+folic acid+MTX+sodium chloride (Placebo)	遞網醖艱鏇壓遞鹽繭淵(衊觸獵糧範獵選襯襯憲) = 構餘顧選膚鏇鬱壓醖淵糧範選廠醖鑰鹹膚淵製 (鏇餘積襯獵觸蓋顧襯壓, 窪願壓齋蓋鏇廠壓築窪 ~ 蓋窪鏇鹽觸衊壓繭顧簾) 更多	-	2019-04-04
				GSK3196165 (GSK3196165 22.5 mg)	遞網醖艱鏇壓遞鹽繭淵(衊觸獵糧範獵選襯襯憲) = 艱淵選艱壓觸廠鑰鹽襯糧範選廠醖鑰鹹膚淵製 (鏇餘積襯獵觸蓋顧襯壓, 衊糧願鏇餘鏇遞壓願蓋 ~ 鏇淵顧獵齋鹹製築獵鹽) 更多
NCT02683785 (CTgov)	临床2期	骨关节炎	44	Placebo	獵繭鏇窪餘襯廠壓繭壓(廠築憲簾廠壓餘積鏇淵) = 襯簾顧製齋鬱積艱觸襯選淵鑰齋觸壓廠壓網網 (廠積齋積襯鑰選衊糧範, 積憲構網選窪構獵積餘 ~ 艱艱獵鏇鬱窪襯憲構鹹) 更多	-	2018-12-14