A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Different Intra Articular (i.a.) Dosages of Sprifermin in Subjects With Primary Osteoarthritis of the Knee

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.

开始日期2013-07-29

申办/合作机构

EMD Serono Research & Development Institute, Inc.

[+1]

NCT01689337

/ Terminated临床2期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Trial to Investigate the Efficacy and Safety of 30 mcg and 100 mcg AS902330 Given as One Cycle of Three Intra-articular Knee Injections Once a Week for Three Weeks as an Adjunct Treatment to Patients Following Microfracture Surgery for Cartilage Injury of the Knee.

This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast growth factor-18 [rhFGF-18]) as an adjunct treatment to subjects following microfracture (MFx) surgery for cartilage injury of the knee.
Primary Objectives
* To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery
* To evaluate the safety profile of Sprifermin (AS902330) when administered intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage injury of the knee
Secondary Objectives
* To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to MFx for cartilage injury repair through symptomatic outcomes and quantitative MRI measurement

开始日期2013-04-01

申办/合作机构

EMD Serono, Inc.

NCT01066871

/ Terminated临床2期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Trial to Investigate the Efficacy and Safety of Weekly Intra-articular (i.a.) Injections of 10, 30, and 100 µg of AS902330 for Three Consecutive Weeks in Patients With Acute Cartilage Injury of the Knee

Several people all over the world suffer from cartilage injuries in the knee. Symptoms include pain, joint swelling, and loss of function. Without repair, cartilage injury may ultimately lead to osteoarthritis (OA). Natural healing is poor, and to date treatment is available only for deep cartilage defects involving also the underlying bone. A promising candidate for drug treatment of cartilage injury is sprifermin (AS902330), a recombinant form of the human fibroblast growth factor (FGF) 18.
So far, the drug has been used in subjects with different stages of knee OA in two ongoing studies without emerging safety issues following single and multiple intra-articular injections of ascending doses. However, OA represents late-stage cartilage injury, where repair might be difficult due to diffuse damage, reduced responsiveness of the cartilage, and/or the involvement of other joint structures.
This clinical trial is meant to provide the proof of concept and to identify an efficacious dose of sprifermin (AS902330) for the treatment of adult subjects with acute cartilage injuries of the knee. The first subject for this trial was treated on the 19th of April 2010.

开始日期2010-03-01

申办/合作机构

Merck KGaA

100 项与 Sprifermin 相关的临床结果

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100 项与 Sprifermin 相关的转化医学

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100 项与 Sprifermin 相关的专利（医药）

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项与 Sprifermin 相关的文献（医药）

2025-03-01·OSTEOARTHRITIS AND CARTILAGE

Exploring a novel outcome measure of symptom progression in knee osteoarthritis utilizing a large randomized trial

Article

作者: Somberg, Kenneth ; Guermazi, Ali ; Conaghan, Philip G ; Katz, Nathaniel ; Clive, Julia ; Goel, Niti ; Hochberg, Marc C ; Hunter, David J ; Johnson, Mary ; Knight, Chris ; Zhao, Luping

OBJECTIVES:

Explore a newly defined composite measure of symptom progression for knee osteoarthritis (KOA) in a large, randomized study of a potential disease-modifying osteoarthritis drug (DMOAD).

DESIGN:

Using longitudinal KOA studies, a potential composite endpoint of time to symptom progression was defined as the first occurrence of worsening of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain of ≥10 points with no improvement (≤9 point decrease) in WOMAC Function (0-100 scale). A post hoc analysis explored discrimination and association with structural outcomes in the sprifermin FORWARD trial through Years 3 and 5. All treatment arms of the intent-to-treat population were analyzed.

RESULTS:

Among the 549 FORWARD participants, 442 (80.5%) completed Year 3, and 378 (68.9%) completed Year 5. Sprifermin showed dose-dependent benefits in the time to symptom progression at Year 3 with hazard ratio (95% CI) for each sprifermin treatment arm vs placebo as follows: 100 μg every 6 months (Q6M), 0.51 (0.28, 0.93); 100 μg Q12M, 0.69 (0.40, 1.20); 30 μg Q6M, 0.89 (0.53, 1.50); and 30 μg Q12M, 0.80 (0.47, 1.35). Similar findings were seen through Year 5 and for a subgroup based on modern clinical trial inclusion criteria. There were increased numbers of knee replacements in symptom progressors (n=8, 5.6%) vs non-progressors (n=7, 1.7%).

CONCLUSIONS:

The symptom progression endpoint discriminated between placebo and treatment responses in a post hoc analysis of a Phase 2 investigational DMOAD KOA trial. The endpoint requires validation and further exploration in DMOAD clinical trials.

TRIAL NUMBER:

NCT01919164.

2024-12-01·Osteoarthritis and cartilage open

Unbiased analysis of knee cartilage thickness change over three years after sprifermin vs. placebo treatment – A post-hoc analysis from the phase 2B FORWARD study

Article

作者: Somberg, Kenneth ; Maschek, Susanne ; Ladel, Christoph ; Bihlet, Asger Reinstrup ; Zhao, Luping ; Wirth, Wolfgang ; Knight, Chris ; Eckstein, Felix

Objective:

Post-treatment cartilage morphometry in the FORWARD study was performed without blinding to MRI acquisition order, involving potential reader bias. Here we obtained unbiased estimates of cartilage change post-treatment, reading year (Y)2 and Y5 MRIs with blinding to time point. We studied whether post-treatment cartilage thickness change differed between sprifermin- and placebo-treated knees.

Methods:

FORWARD was a 5-year randomized control trial in 549 knee osteoarthritis patients. Here, Y2/Y5 images were analyzed with blinding to relative temporal order and treatment group. Cartilage change during Y2→Y5 was obtained in 337 participants: n = 57 treated with placebo intra-articular injections every 6 months (q6M); n = 69 with 30 μg sprifermin every 12 months (q12 M), n = 67 with 30 μg q6M, n = 73 with 100 μg q12 M, and n = 71 with 100 μg q6M between baseline (BL) and 18 M. Total femorotibial joint (TFTJ) cartilage thickness was the primary analytic focus.

Results:

TFTJ cartilage thickness change during Y2→Y5 was -26μm (SD64; 95%CI -32,-19) across the cohort; no statistically significant difference (p = 0.80) was observed between Sprifermin treated or placebo arms (one-way ANOVA). All groups lost cartilage, but the treatment-related difference in cartilage thickness in Sprifermin arms relative to placebo at Y2 was maintained until Y5. Annualized cartilage change in placebo participants was -8.2 μm (SD21; 95%CI -14,-2.5) during Y2→Y5 vs. -5.4 μm (SD27; 95%CI -13,1.8) during BL→Y2; no significant difference was identified (t-test).

Conclusion:

FORWARD is the first study evaluating post-treatment benefits of a potential disease modifying osteoarthritis drug. Cartilage thickness gained with 100 μg sprifermin at Y2 is maintained to Y5 and thus appears viable and sustainable.This is a post-hoc analysis of the FORWARD trial: ClinicalTrials.gov Identifier: NCT01919164.

2024-10-01·OSTEOARTHRITIS AND CARTILAGE

Is detection of disease-modifying osteoarthritis drug treatment more effective when performing cartilage morphometry without blinding to MR image acquisition order?

Article

作者: Somberg, Kenneth ; Maschek, Susanne ; Wisser, Anna ; Ladel, Christoph ; Bihlet, Asger Reinstrup ; Zhao, Luping ; Wirth, Wolfgang ; Knight, Chris ; Eckstein, Felix

OBJECTIVE:

We here explore whether observed treatment effects of a putative disease-modifying osteoarthritis drug (DMOAD) are greater when cartilage morphometry is performed with rather than without knowledge of magnetic resonance imaging (MRI) acquisition order (unblinded/blinded to time point).

METHODS:

In the FORWARD (FGF-18 Osteoarthritis Randomized Controlled Trial with Administration of Repeated Doses) randomized controlled trial, 549 knee osteoarthritis patients were randomized 1:1:1:1:1 to three once-weekly intra-articular injections of placebo, 30 µg sprifermin every 6 or 12 months (M), or 100 µg every 6/12 M. After year 2, cartilage segmentation of BL through 24 M MRIs was performed, with blinding to acquisition order. After year 5, 24 and 60 M MRIs were analyzed together, with unknown relative order, but with segmented BL images as reference (24 M unblinded vs. BL), by the same operators. Total femorotibial joint cartilage thickness (TFTJ_ThC) change was obtained for 352 participants analyzed under both conditions.

RESULTS:

Twenty-four-month data read unblinded to order revealed a -35 ± 44 µm lower TFTJ_ThC than blinded analysis (all groups: lower/upper bounds -120/+51 µm; correlation r² = 97%). With unblinded analysis, the placebo group lost -46 ± 57 µm TFTJ_ThC over 24 M, whereas 100 µg/every 6 M lost -2.2 ± 73 µm (difference =44 µm [95% CI: 22, 66]). With blinded analysis, placebo lost -11 ± 53 µm, whereas 100 µg/every 6 M gained 30 ± 62 µm (difference = 40 µm [95% CI: 21, 60]). 100 µg sprifermin injected every 6 M showed statistically significant (p < 0.001) treatment effects on TFTJ_ThC, with Cohen D = -0.66 for unblinded and D = -0.69 for blinded analysis.

CONCLUSIONS:

These results do not reveal that detection of proposed DMOAD treatment is enhanced with MRIs read unblinded to order; rather, the sensitivity is similar to blinded analysis. Choices on blinded vs. unblinded analysis may thus be based on other criteria.

项与 Sprifermin 相关的新闻（医药）

2025-10-02

·生物制药小编

Fierce Biotech Top15深度解析（上）

近日，Fierce Biotech更新了2025年的Fierce 15榜单。Fierce Biotech认为，即便在今年市场处于熊市的背景下，这些公司仍然能从提名中脱颖而出，这些企业是真正能在伸手不见五指的黑暗中引领整个行业朝着光明前行的。本文将对这些企业进行简单分析，看看这些开发方向是否有可取之处，同时也会对其可能遇到的问题进行简单猜测。 1.Alentis Therapeutics Alentis Therapeutics自从2019年创立以来，先后融了ABCD四轮，2019年1250万美元（A轮） + 2021年6700万美元（B轮） + 2023年1.05亿美元（C轮） + 2025年1.814亿美元（D轮）总计融了约3.66亿美元。靶点选取的CLDN1，CLDN1是紧密连接蛋白家族的一员；它的主要作用是将上皮细胞结合在一起。公司对适应症的开发方向是纤维化疾病和癌症。有趣的是，公司此前开发过一款针对CLDN1+头颈鳞癌的抗体ALE.C04，2023年8月被授予了快速通道，但是不知为何没有继续开发下去，临床试验已经终止。现在公司开发的是两款针对肿瘤的ADC，或许CLDN1抗体的疗效有所不足因此促使公司开发了ADC？总之值得关注。 2.Alterome Therapeutics Alterome Therapeutics也融了不少钱，2022年A轮和A轮扩展分别融了6400万和3500万美元，2024年融了1.32亿美元，总计超2.31亿美元。 2025年1月，Alterome与Imagenomix（AI驱动精准医疗公司）达成合作，利用其AI平台优化临床试验效率、改进患者分层，并加速药物开发。公司还计划与生物标志物检测公司合作，开发伴随诊断工具，以支持其靶向疗法的精准应用。公司目前开发管线有两条，分别是针对AKT1 E17K变异的选择性抑制剂ALTA2618和KRAS选择性抑制剂ALTA3263。传统广谱AKT抑制剂（如阿斯利康已上市的Capivasertib）会同时抑制AKT家族所有亚型（AKT1/AKT2/AKT3），常引发剂量限制性毒性，如高血糖、腹泻和皮疹。而开发专门针对AKT1 E17K变异的选择性抑制剂在抑制效果和安全性上都可能产生改善，早先Nature就文献报道过化合物4在动物实验中未影响血糖水平，而广谱抑制剂ARQ092则导致显著高血糖。不过，这里的另外一个问题可能是，AKT1 E17K并非高频突变，之前Alterome找上Imagenomix进行AI开发或许就是为了更好地进行患者生物标志物管理。从临床入组标准来看，筛选时还需要排除有PI3K和mTOR抑制剂背景，以及KRAS，NRAS，HRAS或BRAF突变背景的患者。 ALTA2618的竞品是ATV-1601，开发公司是Atavisk Bio。 ALTA-3263机制上采用非共价的开关抑制，可靶向> 90%的KRAS突变。这一领域内泛KRAS抑制剂的竞争较为激烈，大都处于临床前期或早期，未来值得关注各自的临床效果。 3.Character Biosciences Character Biosciences 前身为 Clover Therapeutics，是医疗保险公司Clover Health于2019年创立的研发部门，核心任务是通过整合母公司及其他数据源的患者信息，开发针对特定患者亚群的疗法。这一策略依托Clover Health在临床护理领域积累的数据分析技术，为药物研发提供精准的患者分层依据。后来在2022年该公司独立分拆并更名为Character Biosciences。分拆后，公司先后A轮融了1800 万美元，B轮融了9300万美元，后来又在B轮基础上扩展融了1700万美元。转型后的Character Biosciences延续了数据驱动的研发模式，但业务重心转向多基因疾病药物开发。其技术平台通过整合基因组学、临床影像和纵向健康数据，构建了覆盖150余个眼科治疗中心的AMD患者数据库。适应症主要围绕AMD。其中针对AMD的CTX203 是一种全新设计的载脂蛋白A1模拟肽，可在细胞膜上稳定 ABCA1 以增强细胞内脂质外排；还可进行细胞外脂质包装和清除。此外，Character公司已开发并计划部署一种专有的脂质通路特异性多基因风险评分，以识别那些病情进展较快且对脂质调节疗法反应更佳的患者。 CTX114 则是一款同类最佳的补体抑制剂，旨在减缓晚期干性AMD中地图样萎缩的进展速度。 Character似乎还有将其用于干眼症的打算。这家公司目前已经和全球著名的眼科保健公司博士伦达成合作，计划合作开发新药。考虑到AMD传统的VEGF疗法还存在给药频率等问题，看来Character公司认为这一领域的可开发市场和空间仍然很大。 4.Congruence Therapeutics Congruence Therapeutics 成立于2021年，总部位于加拿大蒙特利尔，是一家以计算生物学为核心的生物技术公司，公司利用的是计算生物学来开发针对蛋白质错误折叠疾病的药物。其创始人Clarissa Desjardins博士曾是Clementia Pharmaceuticals的创始人兼CEO。 Congruence公司先后经历了AB两轮融资，2022年A轮5000万美元+2023年扩展轮1500万美元+2025年B轮3200万，总计约9700万美元融资。核心管线是CGX-926，以及另外两款未命名管线。其中CGX-926是全球首个针对MC4R缺陷型肥胖的MC4R激动剂。不过，最近也有研究表明替尔泊肽等GLP-1药物可针对MC4R缺陷型肥胖……所以…… 不过，如果真的能完成技术验证，公司另外另外两款适应症GBA1驱动的帕金森病以及α-1抗胰蛋白酶（A1AT）缺乏症还是比较有发挥空间的。 5.Formation Bio Formation Bio最初不做药，原名叫TrialSpark，是一家CRO，成立于2016 年，其早期业务聚焦于通过技术工具优化临床试验流程。公司最初开发了患者招募工具并对外销售，随后扩展至现场管理与技术支持，成为面向药企的“工具外包商”，专注于解决临床试验中效率低、成本高的痛点。 2021年公司C轮融资后，公司开始从“工具外包商”向“技术驱动的制药公司”转型，不断通过授权交易的方式获得管线。目前公司有三大管线，其中SYK/JAK 抑制剂Gusacitinib非常值得一提，公司从Asana BioSciences 收购了这条管线，并将其开发至临床III期，而今年 6 月，Formation Bio又将Gusacitinib授权给赛诺菲，交易价值可能高达 5.45 亿欧元（约合 6.32 亿美元），包括预付款、里程碑付款，以及基于未来销售额的低至中双位数特许权使用费。另外两款管线分别是从默克那里收购的重组人源FGF18 Sprifermin。从IMIDomics引进的，CD226单抗RVW101，适应症为UC。 6.Georgiamune Georgiamune由Samir Khleif教授创立，Khleif以前主要在在学术界和政府部门工作，担任过国家癌症研究所癌症疫苗部门负责人和佐治亚癌症中心主任等职务。现在他决定跨过学术领域的大山，将研究应用转化。目前公司管线主要围绕T细胞重编程展开。2023 年 8 月，Georgiamune 完成了超额认购的 7500 万美元 A 轮融资。公司的可知信息不多。进入临床的管线有三，其中GIM-122是一款双功能单克隆抗体，靶点不明，目前主要针对PD-1/L1治疗失败的患者。 GIM-531是一款TREG抑制剂，而GIM-407则是TREG激动剂，分别针对癌症和自免性疾病。 7.Incyclix Bio Incyclix Bio相比上述开发的公司融资量就相对少了，2020年A轮600万美元，2022年B轮3000万美元，2025年B+轮1125万美元。公司目前就一款管线INX-315，是一款CDK2抑制剂。CDK2是控制癌细胞生长节奏的关键蛋白，其异常活跃与多种癌症的发生和发展密切相关。INX-315通过抑制CDK2的活性，阻断癌细胞的异常增殖，从而发挥抗癌作用。 INX-315目前正在开展针对CDK4/6抑制剂耐药的雌激素受体（ER）阳性/HER2阴性乳腺癌患者，以及CCNE1扩增实体瘤患者的1/2期临床试验。这是个目前的治疗选择非常有限的患者群体。公司还和礼来达成了合作，双方在乳腺癌临床中使用礼来的CDK4/6抑制剂Verzenio与INX-315进行联合治疗。不过，公司竞品还是很多的，如百济的BG-68501，NiKang Therapeutics的NKT3447，辉瑞的PF-07104091（效果不显著），阿斯利康的AZD8421，Blueprint Medicine的BLU-222（已终止开发），Allorion Therapeutics的ARTS-021，Incyte的INCB123667。 INX-315需要从激烈的竞争中脱颖而出。 8.Nuvig Therapeutics Nuvig Therapeutics目前完成了两轮融资，2022年4700万美元的A轮，2024年1.61亿美元的B轮。公司的核心愿景是做出静脉注射免疫球蛋白（IVIG）的平替。要知道IVIG是从健康人血浆中提取的免疫球蛋白制剂，副作用大不说，还常常需要献血。在慢性炎症性脱髓鞘性多发性神经病（CIDP）这项自身免疫疾病中，IVIG是CIDP的首选治疗药物，约80%的CIDP患者对IVIG治疗有效，但需长期的免疫抑制维持治疗，且存在副作用（如头痛、发热、血栓风险）和高昂成本。 NVG-2089是Nuvig Therapeutics开发的重组Fc片段免疫调节剂。该分子片段经过工程改造，通过结合2型Fc受体去上调FcgRIIb表达，抑制过度免疫反应，触发其内源性调节机制，临床前研究表明，NVG-2089可以在不需要免疫抑制的背景下，发挥抗炎效果。不过，艾加莫德（Efgartigimod）等FcRn拮抗剂也有开发这一市场的打算。NVG-2089的未来市场前景，可能要取决于艾加莫德在CIDP中的临床数据。参考来源： https://www.fiercebiotech.com/special-reports/introducing-fierce-biotechs-2025-fierce-15

临床研究快速通道抗体药物偶联物

2024-06-26

·FierceBiotech

AI-focused Formation secures Sanofi-backed $372M series D to license more drugs

Formation Bio said it plans to deploy new capital to continue to acquire and in-license clinical-stage assets from its biotech and pharma partners. Megarounds have been few and far between in 2024, but Formation Bio has managed to draw in an impressive $372 million series D as the AI-focused biotech seeks to expand its pipeline. AI companies like to promise the world, but Formation’s offering is more mundane. The idea is that Formation will partner with biotechs to improve their workflow automation—such as generating tailored patient recruitment content for specific cohorts of a clinical trial or speedily producing AI-generated adverse event reports. The ambition accelerates when the company looks ahead to the “medium term,” when it hopes to assemble a so-called “AI R&D Scientist” that can “provide drug development teams with decision support and eventually steer high-quality R&D decisions.” “In the long term, the company's goal is to build and train AI models that can better predict toxicity, tolerability, and one day, efficacy,” Formation explained in a June 26 release. The series D was led by a16z with “significant participation” from existing partner Sanofi—which has other AI-focused collaborations with partners including the likes of Owkin and Exscientia. Formation, which was formerly known as TrialSpark, said it plans to deploy this capital to continue to acquire and in-license clinical-stage assets from its biotech and pharma partners. The company currently lists three candidates in its clinical pipeline, including a SYK/JAK inhibitor called gusacitinib in phase 3 development for chronic hand eczema. There’s also a sodium channel blocker called ASN008 in phase 2 trials for notalgia paresthetica and itch associated with atopic dermatitis as well as an FGF18 drug called sprifermin in phase 2 for knee osteoarthritis. Both gusacitinib and ASN008 were bought from Asana BioSciences in 2022, while sprifermin was licensed from Merck KGaA. “By partnering with Formation Bio, smaller biotechs can advance more than just their lead asset, creating a pathway for other drugs in their pipeline,” the company said in the release. “For large pharma companies, Formation Bio creates an ‘off balance sheet’ pathway for development, enabling a company to take more shots on goal in a P&L efficient way.” Sanofi already announced a drug development partnership with both Formation and OpenAI last month. CEO Paul Hudson used a statement in this morning’s release to reemphasize that the French pharma is “all in on AI.” “We are proud to partner with and invest in Formation Bio, whose AI-driven drug development vision and capabilities will help lead our industry forward in the shared ambition to accelerate and improve how we bring more new medicines to patients,” Hudson added.

临床2期并购

2023-10-31

·Science Daily

New hope to treat and reverse osteoarthritis

Current osteoarthritis treatment manages symptoms rather than addressing the underlying disease, but a new study has shown the condition may be treatable and reversible. Current osteoarthritis treatment manages symptoms rather than addressing the underlying disease, but a new University of Adelaide study has shown the condition may be treatable and reversible. Osteoarthritis is the degeneration of cartilage and other tissues in joints and is the most common form of arthritis in Australia, with one in five people over the age of 45 having the condition. It is a long-term and progressive condition which affects people's mobility and has historically had no cure. Its treatment cost the Australian health system an estimated $3.9 billion in 2019-20. Often described as a 'wear and tear' condition, factors such as ageing, obesity, injury and family history contribute to the progression of osteoarthritis. University of Adelaide researchers discovered a novel population of stem cells -- marked by the Gremlin 1 gene -- responsible for the progression of osteoarthritis. Treatment with fibroblast growth factor 18 (FGF18) stimulated the proliferation of Gremlin 1 cells in joint cartilage in mice, leading to significant recovery of cartilage thickness and reduced osteoarthritis. Gremlin 1 cells present opportunities for cartilage regeneration and their discovery will have relevance to other forms of cartilage injury and disease, which are notoriously challenging to repair and treat. It challenges the categorisation of osteoarthritis as wear and tear. "The findings of our study reimagine osteoarthritis not as a 'wear and tear' condition but as an active, and pharmaceutically reversible loss of critical articular cartilage stem cells," said the University of Adelaide's Dr Jia Ng from the Adelaide Medical School, who co-led the study. "With this new information, we are now able to explore pharmaceutical options to directly target the stem cell population that is responsible for the development of articular cartilage and progression of osteoarthritis." While Dr Ng describes current treatments for osteoarthritis as a "Band-Aid approach," this new understanding could lead to a pharmaceutical treatment that reverses osteoarthritis and helps to address health outcomes associated with the disease. "Known comorbidities of osteoarthritis include heart, pulmonary, and kidney disease, mental and behavioural conditions, diabetes, and cancer," said Dr Ng. "Our study suggests that there may be new ways to treat the disease rather than just the symptoms, leading to better health outcomes and quality of life for people who suffer from osteoarthritis." Though this discovery is limited to animal models, Dr Ng said there are genetic similarities to human samples, and human trials are ongoing. "We look forward to the outcome of these trials and to contribute to the better understanding of a pharmaceutical mechanism to treat osteoarthritis," she said. Results of a five-year clinical trial study using FGF18, known clinically as Sprifermin, were published in 2021 with potential long-term clinical benefit and no safety concerns. Phase 3 of the Sprifermin trial is ongoing, and researchers envision public access to this treatment soon.

临床3期

100 项与 Sprifermin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Sprifermin	-	DB12616

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
膝关节炎	临床2期	美国	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	阿根廷	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	捷克	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	丹麦	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	爱沙尼亚	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	中国香港	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	波兰	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝关节炎	临床2期	罗马尼亚	EMD Serono Research & Development Institute, Inc.	2013-07-29
膝盖受伤	临床2期	-	EMD Serono, Inc.	2013-04-01
软骨损伤	临床2期	德国	Merck KGaA	2010-03-01

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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


NCT01919164 (FORWARD, Pubmed \| Semin Arthritis Rheum)	临床2期	膝关节炎	549	Sprifermin 100 µg q6mo	襯襯鑰鏇選製襯餘襯鑰(窪網鹽獵廠網製積廠憲) = 憲壓鬱齋膚鑰願獵範餘夢襯簾糧壓淵膚積齋製 (鑰鏇衊顧築襯繭遞衊淵, ( ~ 22.42, 4.92))	-	2021-03-11
				Sprifermin 100 µg q12mo	襯襯鑰鏇選製襯餘襯鑰(窪網鹽獵廠網製積廠憲) = 膚製襯製製夢蓋獵蓋選夢襯簾糧壓淵膚積齋製 (鑰鏇衊顧築襯繭遞衊淵, ( ~ 6.22, 8.16))
NCT01919164 (FORWARD, CTgov)	临床2期	膝关节炎	549	Placebo (Placebo)	觸鬱願願簾醖衊艱積廠(鬱顧網繭築襯鑰衊築積) = 積鑰窪廠鑰選襯醖廠選鬱遞衊齋網夢憲鏇築醖 (齋壓積願艱醖膚積構獵, 0.07) 更多	-	2020-07-13
				Placebo+Sprifermin (Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles)	觸鬱願願簾醖衊艱積廠(鬱顧網繭築襯鑰衊築積) = 鬱鑰鹹顧觸獵顧壓壓製鬱遞衊齋網夢憲鏇築醖 (齋壓積願艱醖膚積構獵, 0.07) 更多
phase II clinical trial (EULAR2020)	临床2期	骨关节炎 PRO-C2 - \| huARGS \| FBN-C	-	Sprifermin	鬱鹽齋鏇鑰膚膚繭築餘(顧淵憲簾憲糧齋鹽構製) = 鹹艱艱選顧願鏇積願構糧觸糧願簾餘鏇鹽餘鏇 (廠願糧網壓衊艱網簾憲 ) 更多	积极	2020-06-03
				Placebo	鬱鹽齋鏇鑰膚膚繭築餘(顧淵憲簾憲糧齋鹽構製) = 糧鏇遞鹹廠獵網窪願鏇糧觸糧願簾餘鏇鹽餘鏇 (廠願糧網壓衊艱網簾憲 ) 更多
FORWARD study (EULAR2018)	临床2期	膝关节炎	549	Sprifermin	願餘壓範選獵鬱構積簾(艱窪範鹹簾衊艱廠餘壓) = 襯窪構襯艱築廠餘夢繭選鬱顧積網鑰淵餘餘鬱 (餘選簾艱獵繭艱齋窪醖 )	积极	2018-06-13
NCT01066871 (CTgov)	临床2期	软骨损伤	74	AS902330 (Sprifermin (AS902330) 10 mcg)	鑰淵窪積艱鏇鹹網鬱網(簾鬱顧簾蓋衊蓋膚鏇淵) = 製鹽窪糧築夢鹹夢遞蓋顧顧遞鏇選範廠願鹹憲 (獵積觸構淵鏇網憲糧憲, 27.17) 更多	-	2016-03-23
				AS902330 (Sprifermin (AS902330) 30 mcg)	鑰淵窪積艱鏇鹹網鬱網(簾鬱顧簾蓋衊蓋膚鏇淵) = 襯鑰積鬱襯蓋壓憲網鑰顧顧遞鏇選範廠願鹹憲 (獵積觸構淵鏇網憲糧憲, 29.24) 更多
NCT01033994 (Pubmed \| Arthritis Rheumatol)	临床1期	-	168	Sprifermin 100 μg	遞齋壓鏇鏇顧淵願顧鹹(獵鬱衊網憲艱範衊壓範): mean difference = 237 (95% CI, 34 ~ 440), P-Value = 0.028 更多	-	2015-11-01
				Placebo
NCT01689337 (CTgov)	临床2期	膝盖受伤	1	AS902330	夢糧醖願衊窪淵壓簾鹽 = 築顧壓窪餘壓鬱鹽齋蓋壓鹹鏇艱積艱鏇餘窪窪 (簾鹹憲遞夢鑰艱繭齋夢, 選鑰夢齋夢範壓網範選 ~ 衊鬱範夢餘簾艱齋願選) 更多	-	2015-08-31