A Phase 1, Open-Label Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Single Ascending Dose Regimens of XT-150 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

This is a Phase 1, open-label, multi-center safety study of XT-150 in adult participants with Amyotrophic Lateral Sclerosis (ALS).
Participants providing informed consent and meeting all study eligibility criteria will be enrolled in the study and will receive a single injection of XT-150 at the Baseline visit. Follow-up visits will occur over 180 days (6 months) after the injection.
8 participants (4 participants per dose level) will be enrolled sequentially in up to 2 ascending, single dose cohorts: Cohort 1: 1.5 mg XT-150 Cohort 2: 4.5 mg XT-150

开始日期2025-02-01

申办/合作机构

Xalud Therapeutics, Inc.

NCT05196919 / Completed临床2期

A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT- 150 for the Treatment of Facet Joint Osteoarthritis Pain

This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints.
Study drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA) injection into the facet capsule, at the affected spinal level (e.g. Lumbar [L]3-4, L4-5, or L5-Sacrum [S]1) as determined by imaging (e.g., Magnetic resonance imaging [MRI], Computed tomography [CT]), X-ray, etc.) and physical exam.
Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24 participants per treatment group).
0.15 mg XT-150 (1.0 milliliter [mL] total delivered by two 0.5 mL injections)
0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections)
Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)

开始日期2022-02-24

申办/合作机构

Xalud Therapeutics, Inc.

NCT04841512 / Withdrawn临床1/2期

A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain

Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.

开始日期2021-10-01

申办/合作机构

Xalud Therapeutics, Inc.

100 项与 XT-150 相关的临床结果

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100 项与 XT-150 相关的转化医学

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100 项与 XT-150 相关的专利（医药）

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项与 XT-150 相关的文献（医药）

2023-03-01·Immunobiology

Monocyte-derived immature dendritic cells negatively regulate hepatic stellate cells in vitro by secreting IL-10

Article

作者: Liu, Feng ; Chen, Peng ; Zheng, Xiaoyu ; Han, Lei ; He, Di ; Hu, Mingdao ; Xu, Yang

The development of liver fibrosis is associated with inflammatory responses resulting from chronic liver disease. Immature dendritic cells (imDCs) play an important role in modulating the inflammatory environment of the liver. This study investigated the effects of imDCs on the regulation of hepatic stellate cells (HSCs) during liver fibrosis. We isolated and induced imDCs from monocytes of healthy volunteers, activated LX-2 cells with TGF-β to establish in vivo liver fibrosis HSCs model, and then set up a cell co-culture system with transwell membranes. imDC surface markers and apoptosis rates of LX-2 cells were detected by flow cytometry. The concentration of IL-10 secreted by imDC was measured through ELISA. The expression of α-SMA in LX-2 after co-culture was examined by qRT‑PCR. Proliferation of LX-2 cells were detected by CCK-8. The western blot was used to illustrate the LX-2 activation-related proteins such as Smad3/7 and TGF-β1. The imDCs co-culture group and the interleukin-10 (IL-10) treatment group had similar results, as they were both able to increase apoptosis, inhibit proliferation, downregulate α-SMA mRNA, and reduce TGF-β1 and Smad3 protein expression in LX-2 cells. Additionally, the Smad7 protein level was increased after treatment with imDC and IL-10. However, the results in the IL-10 antagonist group showed the opposite trend to that of imDCs and IL-10 groups. Thus, these results suggest that imDC secretion of IL-10 negatively regulates activated LX-2 cells, probably via inhibition of the TGF-β1/Smad3 pathway and increased expression of Smad7 protein. This may be a potential therapeutic target for liver fibrosis.

2022-09-01·PNAS nexus

A filarial parasite-encoded human IL-10 receptor antagonist reveals a novel strategy to modulate host responses

Article

作者: Nutman, Thomas B ; Bennuru, Sasisekhar ; Ricciardi, Alessandra ; Hassan, Sergio A ; Kamenyeva, Olena ; Andersen, John

Abstract:

Interleukin (IL)-10 is the primary cytokine driving the modulation of the host response in filarial infections. We performed binding assays with Brugia malayi antigen extracts and human IL-10R1. Bm5539 was the top-binding hit. We identified a short sequence, termed truncated Bm5339, that has structural similarities to the human IL-10 functional dimer. Sequence comparisons revealed that other filarial parasites possess Bm5539 orthologues. Using recombinant Bm5539 in a modified Luciferase Immunoprecipitation System assay, we confirmed that both the truncated and full-length forms of the protein can bind to human IL-10R1. Truncated Bm5539 could inhibit human IL-10-driven phosphorylation of STAT3, thereby demonstrating that Bm5539 acts as an IL-10 antagonist, most likely through competitive binding to the receptor. We provide a structural basis for these observations using computational modeling and simulations. This parasite-encoded cytokine receptor antagonist provides an additional lens through which parasite-induced modulation of the host immune response can be examined.

2017-01-01·Brain, behavior, and immunity1区 · 医学

Behavioral assessment of neuropathic pain, fatigue, and anxiety in experimental autoimmune encephalomyelitis (EAE) and attenuation by interleukin-10 gene therapy

1区 · 医学

Article

作者: Mahoney, Melissa J ; Christianson, John P ; Watkins, Linda R ; Grace, Peter M ; Maier, Steven F ; Loram, Lisa C ; van Dam, Anne-Marie ; Chavez, Raymond A ; Penzkover, Kathryn R ; Flyer-Adams, Johanna G ; Forsayeth, John R ; Strand, Keith A

Relapsing-remitting multiple sclerosis is commonly associated with motor impairments, neuropathic pain, fatigue, mood disorders, and decreased life expectancy. However, preclinical pharmacological studies predominantly rely on clinical scoring of motor deficit as the sole behavioral endpoint. Thus, the translational potential of these studies is limited. Here, we have assessed the therapeutic potential of a novel anti-inflammatory interleukin-10 (IL-10) non-viral gene therapy formulation (XT-101-R) in a rat relapsing remitting experimental autoimmune encephalomyelitis (EAE) model. EAE induced motor deficits and neuropathic pain as reflected by induction of low-threshold mechanical allodynia, suppressed voluntary wheel running, decreased social exploration, and was associated with markedly enhanced mortality. We also noted that voluntary wheel running was depressed prior to the onset of motor deficit, and may therefore serve as a predictor of clinical symptoms onset. XT-101-R was intrathecally dosed only once at the onset of motor deficits, and attenuated each of the EAE-induced symptoms and improved survival, relative to vehicle control. This is the first pharmacological assessment of such a broad range of EAE symptoms, and provides support for IL-10 gene therapy as a clinical strategy for the treatment of multiple sclerosis.

项与 XT-150 相关的新闻（医药）

2024-02-04

·CPHI制药在线

恒瑞1类新药MOR激动剂获批上市；K药和司美格鲁肽2023年均大卖，年销售额超200亿美元 | 制药在线一周药闻复盘

点击蓝字关注我们本周，恰逢全球各大医药巨头出年报的时候，热点不少。首先是审评审批方面，很值得关注的就是恒瑞1类新药MOR激动剂获批上市，用于治疗术后疼痛；其次研发方面，石药集团启动TG103对比度拉糖肽治疗2型糖尿病患者的头对头Ⅲ期临床试验；再次是投融资方面，赛诺菲与Synthekine达成合作，开发IL-10R激动剂；然后是上市方面，康乐卫士和华昊中天均在港交所递交IPO申请；最后是年报方面，两个药大卖，分别是K药和司美格鲁肽，全年销售额分别达到250.11和212.01亿美元。本期盘点包括审评审批、研发、交易及投融资、上市及年报5大板块，统计时间为1.29-2.2，包含27条信息。审评审批NMPA上市批准1、1月31日，NMPA官网显示，恒瑞医药1类新药富马酸泰吉利定注射液（商品名：艾苏特）获批上市，适用于腹部手术后中重度疼痛。泰吉利定注射液是一种靶向MOR的小分子药物，可激活MOR受体，适用于镇痛治疗。申请2、1月31日，CDE官网显示，科笛集团的CU-40102申报上市，拟用于治疗雄激素性脱发。CU-40102是全球首个亦是唯一一个获批用于雄激素性脱发治疗的外用非那雄胺产品，也是中国首个申报上市的外用非那雄胺。临床批准 3、1月31日，CDE官网显示，阿斯利康1类新药baxdrostat片获批临床，拟用于治疗其他药物治疗后控制不佳的高血压患者。Baxdrostat是一种醛固酮合成酶抑制剂（ASI），最初由CinCorPharma公司开发。2023年，阿斯利康通过收购CinCorPharma公司获得了baxdrostat，以拓展其心肾疾病领域的在研产品管线。4、1月31日，CDE官网显示，至善唯新的ZS805注射液获批临床，拟用于治疗法布雷病。ZS805作为一款rAAV基因治疗药物，其基因表达盒框架搭载了该公司自主研发的肝脏特异启动子和信号肽序列优化后的α-半乳糖苷酶A基因。申请5、2月2日，CDE官网显示，信达的IBI133申报临床。IBI133是信达布局的一款HER3ADC。目前全球范围内尚未有HER3ADC获批上市，当前仅10款产品进入临床阶段，其中仅靶向HER3的有8款。进展最快的为第一三共/默沙东的HER3-DXd（U3-1402），BLA申请已获FDA受理并获得优先审查资格，PDUFA日期为2024年6月26日。突破性治疗6、2月1日，CDE官网显示，恒瑞医药的注射用SHR-A1811拟纳入突破性疗法，用于既往至少一线抗HER2治疗失败的HER2阳性晚期胃癌或胃食管结合部腺癌患者。SHR-A1811是恒瑞医药自主研发的一款HER2ADC。优先审评7、1月31日，CDE官网显示，辉瑞（Pfizer）的elranatamab注射液申报上市并拟纳入优先审评，用于治疗既往接受过至少三种治疗的复发或难治性多发性骨髓瘤（MM）成人患者。公开elranatamab是一款皮下注射BCMA×CD3双特异性抗体，已于2023年8月获美国FDA加速批准，用于治疗复发/难治性MM患者。8、1月31日，CDE官网显示，正大天晴的贝莫苏拜单抗注射液与盐酸安罗替尼胶囊联合疗法申报上市拟纳入优先审评，用于既往接受过一、二线化疗方案治疗失败或不能耐受的非微卫星高度不稳定（非MSI-H）或非DNA错配修复缺陷（非dMMR）的复发性或转移性子宫内膜癌的治疗。贝莫苏拜单抗是一款抗PD-L1单抗，安罗替尼是一款小分子多靶点受体酪氨酸激酶抑制剂。FDA上市批准9、1月29日，FDA官网显示，恒瑞医药的他克莫司缓释胶囊获批上市，适用于与其他免疫抑制剂联合，用于预防成人肾脏移植术后的移植物排斥反应。恒瑞他克莫司缓释胶囊是FDA批准上市的该品种首仿药。他克莫司属于钙调神经磷酸酶抑制剂（CNI），原研他克莫司缓释胶囊于2007年在欧盟上市，后陆续在日本、中国、美国等全球七十多个国家和地区上市。申请10、1月29日，FDA官网显示，Celltrion美国子公司CelltrionUSA的CT-P47递交生物制品许可申请（BLA），该产品为第2款在美国申报上市的托珠单抗生物类似药。原研托珠单抗是罗氏子公司中外制药推出的一款抗白介素-6受体（IL-6R）单抗，于2005年首次在日本获批上市，后于2010年在美国获批上市。临床批准11、1月29日，FDA官网显示，原启生物的OriCAR-017获批临床，拟用于治疗复发/难治性多发性骨髓瘤（R/RMM）患者。OriCAR-017是原启生物自主研发的一款靶向GPRC5D的嵌合抗原受体T细胞疗法（CAR-T）。12、1月29日，FDA官网显示，亘喜生物的GC012F疗法获批临床，拟用于治疗多发性骨髓瘤（ELMM）。GC012F正是一款基于亘喜生物专有的FasTCAR次日生产平台开发的BCMA和CD19双靶点自体CAR-T。此次是美国FDA授予GC012F的第三个IND批件。优先审评13、1月29日，FDA官网显示，阿斯利康和第一三共的德曲妥珠单抗（Enhertu）递交补充生物制品许可申请（sBLA），拟用于治疗不可切除或转移性HER2表达实体瘤成人患者，这些患者既往接受过治疗或没有令人满意的替代治疗方案。此外，FDA还授予该sBLA优先审查资格。德曲妥珠单抗是一款靶向HER2的抗体药物偶联物（ADC）。快速通道资格14、2月1日，FDA官网显示，百吉生物的BST02注射液被授予快速通道资格，用于治疗所有类型的肝癌（包括肝细胞癌和胆管癌）。针对该适应症，BST02已于2023年10月在美国获批临床。BST02注射液是一款从患者自身肿瘤浸润淋巴细胞（TIL）中扩增所得到的T细胞治疗产品，属于过继性免疫细胞治疗技术。EMA上市申请15、1月29日，EMA官网显示，葛兰素史克（GSK）的重组呼吸道合胞病毒（RSV）疫苗Arexvy新适应症申报上市，拟将适用范围扩大到50-59岁的RSV高危成人，预计EMA将于2024年下半年做出决定。如果该申请获得批准，Arexvy将成为首个可用于保护此类人群的RSV疫苗。研发临床状态16、1月31日，clinicaltrials.gov官网显示，石药集团启动了TG103对比度拉糖肽治疗2型糖尿病患者的头对头Ⅲ期临床试验（SYSA1803-009）。TG103是天境生物与天士力合作开发的一款长效重组人源GLP-1-Fc融合蛋白，2018年，石药集团与天境生物达成合作协议，以1.5亿元人民币获得了该药物在中国的独家临床开发和商业化权益。交易及投融资17、1月29日，Hookipa宣布，收到罗氏终止HB-700项目合作协议的通知，公司将重新获得HB-700项目的全球开发权益。2022年10月，罗氏与Hookipa达成战略合作和许可协议，共同开发用于KRAS突变癌症的HB-700。根据协议条款，Hookipa有资格获得HB-700与其他候选产品的开发和商业化里程碑付款（总额约为9.3亿美元）。18、1月29日，Synthekine宣布，与赛诺菲达成合作，以开发和商业化用于治疗炎症性疾病的白介素-10受体激动剂。根据条款，赛诺菲将全权负责后续临床前、临床和商业化工作。Synthekine将收到4000万美元预付款，并将有资格获得额外的付款。目前，全球共15款在研IL-10/IL-10R靶向药物处于临床阶段。礼来的Pegilodecakin与XaludTherapeutics的XT-150进度最快。上市19、1月29日，香港证券交易所网站显示，康乐卫士已经在港交所递交IPO申请并获得受理。康乐卫士是一家临床阶段的疫苗研发公司，拥有丰富的HPV疫苗产品组合。该公司已有3款核心候选疫苗处于临床开发阶段，并有6种开发中的临床前候选疫苗。20、1月29日，香港证券交易所网站显示，华昊中天已经在港交所递交IPO申请并获得受理。华昊中天是一家合成生物学技术驱动的生物医药公司，致力于开发肿瘤创新药。该公司已经开发了专注于微生物代谢产物新药研发的三大核心技术平台，并建立了多元的产品组合，包括一款已商业化产品优替德隆注射液以及由19个项目组成的管线。年报21、1月30日，辉瑞发布2023年财报。因新冠疫情逐渐消散，疫苗Comirnaty和口服药物Paxlovid收入大幅下降（124.99vs.567.39亿美元），辉瑞全年总营收下降至584.96亿美元（-41%）。此外，全年研发投入为106.79亿美元，同比下降6%。2023年，抗肿瘤、心血管和免疫产品仍然是辉瑞的主要收入来源。22、1月31日，GSK发布2023年财报。全年营收303.28亿英镑（约为378.46亿美元，按2023年平均汇率1英镑=1.2479美元换算，下同），同比增长5%（按固定汇率计算）。研发投入62.23亿英镑（约77.66亿美元，+14%），占到总收入的21%。特药（SpecialtyMedicines）、疫苗（Vaccines）以及普药（GeneralMedicines）三大块收入已持平。23、1月31日，诺华发布2023年财报。全年营收454.40亿美元，同比增长10%。净利润85.72亿美元，同比上涨62%。研发投入113.71亿美元，占营收25%。销售最高的药是沙库巴曲缬沙坦钠（Entresto）年销售额60.35亿美元，同比增长31%。24、1月31日，诺和诺德发布2023年财报。全年营收2322.61亿丹麦克朗（约337.71亿美元），同比增长31%，营业利润为1025.74亿丹麦克朗（约149.14亿美元），同比增长37%。（按2023年平均汇率：1丹麦克朗=0.1454美元计算）。司美格鲁肽作为诺和诺德的明星产品，2023年共取得了1458.11亿丹麦克朗（212.01亿美元）的销售额。25、2月1日，罗氏发布2023年财报。全年营收587.16亿瑞士法郎（约656.27亿美元，按2023年平均汇率换算：1瑞士法郎=1.1177美元，下同），同比增长1%（按CER计算，下同）；净利润123.58亿瑞士法郎，同比增长7%；研发投入132.37亿瑞士法郎，同比增长5%。销售最高的药物是奥瑞利珠单抗（Ocrevus），年销售额63.81亿瑞士法郎，同比增长13%。26、2月1日，赛诺菲发布2023年财报。全年营收430.70亿欧元（约470.97亿美元，按2023年平均汇率1欧元=1.0935美元换算，下同），同比增长5.3%（按固定汇率计算）。其中度普利尤单抗收入再创新高，达到107.15亿欧元（约117.17亿美元，+34%）。27、2月1日，默沙东发布2023年财报。全年营收601.15亿美元，同比增长1%；若排除新冠口服药Molnupiravir（LAGEVRIO），则增长9%。2023年K药全年销售额已达到250.11亿美元，同比增长19%。【智药研习社课程预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

申请上市优先审批突破性疗法上市批准临床3期

2024-01-30

·Pharmaceutical Technology

Sanofi partners with Synthekine to develop IL-10 therapeutics

Sanofi has entered a partnership with Synthekine for IL-10 therapeutic development. Credit: Keitma via Shutterstock. Canadian immunotherapy company Synthekine has announced a global partnership with Sanofi to develop IL-10 receptor agonists for inflammatory diseases. Under the deal, Sanofi and Synthekine will work together to research cytokine therapies up to a predefined point in preclinical development. After that, Sanofi will be solely responsible for preclinical, clinical and commercial development of any IL-10 therapeutics. Sanofi has agreed to give Synthekine a $40m upfront payment, with the potential for additional payments upon reaching preclinical, development, regulatory and commercial milestones, including possible royalties on net sales. In its programme, the biotech aims to remove the immunostimulatory effects of the drug class, hampering the drug’s toxicity while maintaining efficacy. In its pipeline, the biotech currently has two Phase I candidates and seven candidates in preclinical and investigational new drug application (IND)-enabling stages. These therapies include engineered cytokine partial agonists, surrogate cytokine agonists, and orthogonal cytokine and cell therapy combinations. Synthekine’s most advanced therapy, STK-012, is a modified IL-2 cytokine that selectively stimulates antigen-activated T cells . In September 2023, Synthekine announced the dosing of the first patient in its Phase Ib study (NCT05098132). The ongoing trial is investigating the therapy for solid tumour types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Several companies have investigated IL-10, an immune regulatory cytokine, as a potential target for immunosuppressive agents. The US Food and Drug Administration (FDA) has not yet approved any IL-10 therapeutics. According to GlobalData, six pharmaceutical companies are investigating IL-10 therapeutics in Phase II studies and three Phase I candidates. Xalud Therapeutics is investigating its IL-10 therapy, XT-150 in Phase II studies for neuropathic pain (NCT04466410) and osteoarthritic pain (NCT04124042). Others such as Kolon Life Science and Sunho Biopharmaceutical are also exploring their IL-10 therapeutics in Phase II studies. GlobalData is the parent company of Pharmaceutical Technology. In the 29 January press release, Synthekine’s CEO Debanjan Ray said: “This strategic collaboration will advance our broad efforts on IL-10 to capture the full therapeutic potential of this important target and leverages both our cytokine partial agonist platform and our surrogate cytokine agonist platform.”

临床1期临床2期引进/卖出免疫疗法

2023-03-26

·药明康德

第一三共ADC两项早期临床研究数据积极；12周减重近8%的双机制疗法… | 一周盘点

▎药明康德内容团队编辑本期看点1. 第一三共（Daiichi Sankyo）公司公布了其靶向HER3的抗体偶联药物（ADC）patritumab deruxtecan在两项早期临床试验中获得的积极结果。2. 用于治疗膝骨关节炎的局部注射的质粒DNA（pDNA）基因疗法XT-150在早期临床试验中能显著改善膝关节的运动范围。3. 治疗肥胖或超重的2型糖尿病患者的双机制疗法pemvidutide公布积极数据，12周时最高剂量组患者减重近8%，且葡萄糖稳态得以维持。药明康德内容团队整理Patritumab deruxtecan（HER3-DXd）：公布两项早期临床数据第一三共公司公布了其靶向HER3的ADC patritumab deruxtecan在两项早期临床试验中获得的积极结果，这两项试验中的患者既往均已接受过多线治疗。Patritumab deruxtecan是第一三共基于其DXd抗体偶联药物平台开发的潜在“first-in-class”HER3靶向ADC。在针对表达HER3的转移性乳腺癌患者的1/2期临床试验中，patritumab deruxtecan对不同亚群的乳腺癌患者均显示出有希望的临床活性。在HR阳性乳腺癌患者中，HER2低表达患者确认的的客观缓解率（ORR）为36.2%，中位缓解持续时间（DOR）为7.2个月，中位无进展生存期（PFS）为5.8个月，中位总生存期（OS）为13.7个月；HER2不表达患者的确认的ORR为28.2%，中位DOR为7.0个月，中位PFS为8.2个月，中位OS为14.6个月。在三阴性乳腺癌患者中，HER2低表达患者确认的ORR为20.7%，中位DOR为4.1个月，中位PFS为4.4个月，中位OS为12.7个月；HER2不表达患者的确认的ORR为26.3%，中位DOR为8.4个月，中位PFS为8.4个月，中位OS为16.6个月。更多数据请见下表：▲Patritumab deruxtecan治疗表达HER3的转移性乳腺癌患者的1/2期临床试验结果总结（图片来源：参考资料[1]）在针对携带EGFR突变的转移性非小细胞肺癌（NSCLC）患者的1期临床试验中，中位随访时间为23个月时，patritumab deruxtecan显示了良好的临床疗效。试验采用盲态独立中心审评（BICR），102例患者的ORR为40.2%，1例患者达到完全缓解（CR），40例患者达到部分缓解（PR），39例患者达到疾病稳定（SD），疾病控制率（DCR）为78.4%，中位DOR为7.6个月，中位PFS为6.4个月，中位OS为15.8个月。78例既往接受过第三代EGFR TKI和含铂化疗患者亚组的疗效结局与总人群的疗效结局基本一致。此外，在有和无中枢神经系统（CNS）转移病史的患者中观察到的确认的ORR分别为36.4%和44.7%。更多数据请见下表：▲Patritumab deruxtecan治疗携带EGFR突变的NSCLC患者的1期临床试验结果总结（图片来源：参考资料[1]）XT-150：公布早期临床试验结果Xalud Therapeutics公司公布了其局部注射的pDNA基因疗法XT-150治疗膝骨关节炎的早期临床试验的积极数据。XT-150旨在表达IL-10的专有修饰版本IL-10v，可作为多种炎症通路的主要调节剂，解决多种慢性炎症（包括肌肉骨骼和神经退行性疾病等）中炎症的根本原因。此次公布的数据显示，这种新型基因疗法能改善膝关节的功能，包括膝关节运动范围（ROM）和步行速度。从基线到治疗后180天时，XT-150 150 µg剂量组的膝关节ROM增加了4°，XT-150 450 µg剂量组的膝关节ROM增加了6°，而同一时间段内，安慰剂组的膝关节ROM没有变化。在第120天和第180天，事后分析显示，安慰剂组和XT-150 450 µg剂量组组间膝关节ROM的变化具有统计学意义（分别为p=0.042和p=0.022）。之前的研究已经表明，全膝关节置换术后膝关节屈曲ROM的增加与日常身体活动水平的改善呈正相关。因此，在此分析中膝关节屈曲ROM的改善也可能对身体活动水平产生积极影响。步行速度方面，尽管所有组的步行速度似乎都较基线有所增加，但在所有时间点上的步速增加与基线相比均没有发现统计学上的显著差异。不过重要的是，到第180天时，XT-150 450 µg剂量组中27%的患者的步行速度增加到超过1.3 m/s（该步速是安全过马路所需的建议速度）。Pemvidutide：公布1b期临床试验数据Altimmune公司公布了其候选药物pemvidutide治疗肥胖或超重的2型糖尿病患者为期12周的1b期安全性临床试验的积极结果。Pemvidutide是一款基于多肽的GLP-1/胰高血糖素双重受体激动剂。胰高血糖素能够增加能量消耗，并且促进身体中储存能量的白色脂肪转化为消耗能量的褐色脂肪。它与GLP-1产生协同作用，有望促进比GLP-1受体激动剂单药更有效的体重减轻。胰高血糖素也被认为对肝脏脂肪代谢有直接影响，能够使肝脏脂肪水平迅速降低。此次公布的1b期临床试验结果显示，在12周治疗期间，接受pemvidutide 1.2 mg、1.8 mg和2.4 mg剂量的受试者的平均体重分别减轻4.4%、6.1%和7.7%，安慰剂组平均体重增加0.8%。在整个12周的治疗期间，葡萄糖稳态得以维持，空腹血糖或HbA1c无显著变化，且未发生高血糖的不良事件。在接受pemvidutide治疗的患者中未观察到严重不良事件。胃肠道不良事件的发生率较低，没有导致研究中止的不良事件。SNS-101：向FDA提交IND申请SNS-101是Sensei Biotherapeutics公司开发的一种条件激活的单克隆IgG1抗体，旨在选择性阻断肿瘤微环境中的VISTA检查点，该检查点通过结合其受体PSGL-1来抑制T细胞。临床前研究表明，SNS-101作为单一疗法具有抑制肿瘤生长的潜力，可显著增强PD-1阻断剂的抗肿瘤作用，并降低细胞因子释放综合征的风险。Sensei公司计划评估SNS-10作为单一疗法或与其他疗法联合使用作为实体肿瘤患者的一种新疗法。AVD-104：向FDA提交IND申请AVD-104是Aviceda Therapeutics公司开发的用于眼睛玻璃体内的新型聚糖涂层纳米颗粒，旨在治疗65岁以上人群中最常见的致盲眼病——年龄相关性黄斑变性（AMD）相关的地图样萎缩（GA）。AVD-104已被证明具有强大的体外/体内功效，可抑制炎症和补体通路，并有望每4-6个月给药一次。在临床前研究中，AVD-104已在包括非人类灵长类动物在内的多种动物模型中证明了其卓越的安全性。此外，在成熟的眼部脉络膜新生血管模型中，AVD-104已被证明与已获FDA批准的药物aflibercept（商品名：Eylea）相比具有同等的新血管形成预防作用。VTP-200：公布1b/2期临床试验的中期数据Vaccitech公司公布了其在研异源初免加强免疫疗法VTP-200用于治疗持续性高危HPV感染和相关的癌前病变的早期临床试验的中期数据。结果显示，VTP-200一般耐受性良好，没有发生相关的严重不良事件。初步的免疫原性结果显示出高反应，尤其是对E1、E2和E6抗原。该临床试验将按计划继续进行至12个月时的主要终点。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Patritumab Deruxtecan Continues to Show Encouraging Clinical Activity in Distinct Patient Populations with Metastatic Lung and Breast Cancer in Updated Results of Two Early Trials. Retrieved March 24, 2023, from https://www.businesswire.com/news/home/20230317005395/en/[2] OliX Pharmaceuticals Receives Regulatory Approval to Commence Phase 1 Clinical Trial of Treatment of Androgenic Alopecia. Retrieved March 24, 2023, from https://www.businesswire.com/news/home/20230323005383/en/[3] Bridgebio pharma announces first lung cancer patient dosed in phase 1 trial for shp2 inhibitor bbp-398 in combination with bristol myers squibb’s opdivo® (nivolumab). Retrieved March 24, 2023, from https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-pharma-announces-first-lung-cancer-patient-dosed-0[4] DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCi™ STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM. Retrieved March 24, 2023, from https://www.prnewswire.com/news-releases/debiopharm-announces-launch-of-the-phase-12-galuci-study-for-its-ca-ix-targeted-radiopharmaceutical-program-301777849.html[5] Vaccinex Announces Initiation of Single-Arm Open Label, Phase Ib/2 Study to Evaluate Pepinemab in Combination with Avelumab as Second Line Combination Immunotherapy for Patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Retrieved March 24, 2023, from https://ir.vaccinex.com/news-releases/news-release-details/vaccinex-announces-initiation-single-arm-open-label-phase-ib2[6] Allarity Therapeutics Doses First Patient in Phase 1b Clinical Trial Evaluating Dovitinib and Stenoparib Combination in Advanced Solid Tumors. Retrieved March 24, 2023, from https://investors.allarity.com/news/news-details/2023/Allarity-Therapeutics-Doses-First-Patient-in-Phase-1b-Clinical-Trial-Evaluating-Dovitinib-and-Stenoparib-Combination-in-Advanced-Solid-Tumors/default.aspx[7] Fusion Pharmaceuticals Announces First Patient Dosed in Phase 1 Study of FPI-2059, a Targeted Alpha Therapy (TAT) for the Treatment of Solid Tumors Expressing NTSR1. Retrieved March 24, 2023, from https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-announces-first-patient-dosed-in-phase-1-study-of-fpi-2059-a-targeted-alpha-therapy-tat-for-the-treatment-of-solid-tumors-expressing-ntsr1-301776369.html[8] Phanes Therapeutics Announces First Patient Dosed in Phase 1 Study of PT886 for Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas. Retrieved March 24, 2023, from https://www.prnewswire.com/news-releases/phanes-therapeutics-announces-first-patient-dosed-in-phase-1-study-of-pt886-for-advanced-gastric-gastroesophageal-junction-and-pancreatic-adenocarcinomas-301776427.html[9] RayzeBio Completes Phase 1b Enrollment in ACTION-1 Study, Evaluating RYZ101 (Actinium-225 DOTATATE) in Neuroendocrine Tumors. Retrieved March 24, 2023, from https://www.businesswire.com/news/home/20230320005182/en/[10] Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of VXX-401, Investigational Anti-PCSK9 Vaccine to Treat Hypercholesterolemia. Retrieved March 24, 2023, from https://ir.vaxxinity.com/news-releases/news-release-details/vaxxinity-announces-first-subjects-dosed-phase-1-clinical-0[11] GRIN Therapeutics Announces First Patient Dosed in Phase 1B Clinical Trial with Radiprodil for Treatment of GRIN-related Disorders. Retrieved March 24, 2023, from https://www.businesswire.com/news/home/20230323005287/en/[12] Aviceda Announces Successful Submission of an Investigational New Drug (IND) and Fast Track Designation (FTD) Application for AVD-104 for the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration (AMD). Retrieved March 24, 2023, from https://www.businesswire.com/news/home/20230320005017/en[13] Vaccitech’s VTP-200 Ph 1b/2 Study Demonstrates Favorable Tolerability and Immunogenicity Profile at Interim Analysis in Women with Low-Grade Human Papillomavirus (HPV)-related Cervical Lesions. Retrieved March 24, 2023, from https://investors.vaccitech.co.uk/news-and-events/news-releases/news-release-details/vaccitechs-vtp-200-ph-1b2-study-demonstrates[14] Xalud Therapeutics Presents Clinical Data on XT-150 in Knee Osteoarthritis at the 2023 Osteoarthritis Research Society International World Congress. Retrieved March 24, 2023, from https://www.biospace.com/article/releases/xalud-therapeutics-presents-clinical-data-on-xt-150-in-knee-osteoarthritis-at-the-2023-osteoarthritis-research-society-international-world-congress/[15] Sensei Biotherapeutics Announces Submission of Investigational New Drug (IND) Application for SNS-101, a Conditionally Active VISTA-Blocking Antibody. Retrieved March 24, 2023, from https://investors.senseibio.com/news-releases/news-release-details/sensei-biotherapeutics-announces-submission-investigational-new[16] Altimmune Announces Positive Results from Week 24 Interim Analysis of Pemvidutide MOMENTUM Phase 2 Obesity Trial and 12-Week Phase 1b Type 2 Diabetes Safety Trial. Retrieved March 24, 2023, from https://www.globenewswire.com/news-release/2023/03/21/2631138/0/en/Altimmune-Announces-Positive-Results-from-Week-24-Interim-Analysis-of-Pemvidutide-MOMENTUM-Phase-2-Obesity-Trial-and-12-Week-Phase-1b-Type-2-Diabetes-Safety-Trial.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果抗体药物偶联物基因疗法临床2期

100 项与 XT-150 相关的药物交易

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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
骨关节炎	临床3期	美国	Xalud Therapeutics, Inc.	-
背痛	临床2期	美国	Xalud Therapeutics, Inc.	2022-02-24
炎症	临床2期	美国	Xalud Therapeutics, Inc.	2022-02-24
关节痛	临床2期	澳大利亚	Xalud Therapeutics, Inc.	2021-10-01
脊椎骨关节炎	临床2期	澳大利亚	Xalud Therapeutics, Inc.	2021-10-01
膝关节炎	临床2期	美国	Xalud Therapeutics, Inc.	2020-02-14
膝关节炎	临床2期	澳大利亚	Xalud Therapeutics, Inc.	2020-02-14
疼痛	临床2期	美国	Xalud Therapeutics, Inc.	2020-02-14
疼痛	临床2期	澳大利亚	Xalud Therapeutics, Inc.	2020-02-14
肌萎缩侧索硬化	临床1期	美国	Xalud Therapeutics, Inc.	2025-02-01