A Clinical Study to Evaluate the Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) Tablet With Itraconazole and Rifampin in Healthy Chinese Adult Volunteers

The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are:
How does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine?
Participants will:
Take Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence.
Attend multiple clinic visits for blood sample collection and safety evaluations.
Researchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.

开始日期2024-12-12

申办/合作机构

上海嘉坦医药科技有限公司

NCT06701110 / Recruiting临床1期

Pharmacokinetics and Mass Balance Study of WX-081 (Sudapyridine) in Healthy Chinese Volunteers

This single-center, open-label, non-randomized study aims to evaluate the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) following a single oral dose of [U-14C] WX-081 in healthy Chinese male volunteers. A total of 6-10 subjects will be enrolled to obtain complete samples and data from at least six participants. Biological samples, including blood, plasma, urine, and feces, will be collected over a specified time period. The study will assess pharmacokinetic parameters, excretion pathways, and identify major metabolites contributing to over 10% of plasma exposure.

开始日期2024-09-04

申办/合作机构

上海嘉坦医药科技有限公司

NCT05824871 / Recruiting临床3期

A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Oral Sudapyridine (WX-081) Tablets in Patients With Rifampicin-Resistant Pulmonary Tuberculosis

This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant pulmonary tuberculosis.
Approximately 450 participants will be screened over a period of up to 2 weeks and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline, in combination with placebo tablets and BR, for 24 weeks. After the treatment period, participants will enter a background regimen period up to Week 72, during which they will continue to receive BR.
A subset of participants will be included in the C-QT sub-study to assess intensive PK sampling and 12-lead ECG evaluations on Day 1 pre-dose, Day 14, and Week 24.
The study aims to provide robust data to support the use of Sudapyridine as a treatment option for rifampicin-resistant pulmonary tuberculosis.

开始日期2022-09-02

申办/合作机构-

100 项与 Sudapyridine 相关的临床结果

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100 项与 Sudapyridine 相关的转化医学

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100 项与 Sudapyridine 相关的专利（医药）

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项与 Sudapyridine 相关的文献（医药）

2024-02-28·mSphere

Sudapyridine (WX-081) antibacterial activity against Mycobacterium avium , Mycobacterium abscessus , and Mycobacterium chelonae in vitro and in vivo

Article

作者: Qi, Xueting ; Chen, Xiaoyou ; Zheng, Luyao ; Wang, Bin ; Lu, Yu ; Zhang, Weiyan ; Chen, Xi ; Fu, Lei ; Wang, Hong

ABSTRACT:

Sudapyridine (WX-081) is a structural analog of bedaquiline (BDQ), which shows anti-tuberculosis and non-tuberculous mycobacteria (NTM) activities but, unlike BDQ, did not prolong QT interval in animal model studies. This study evaluated the antibacterial activity of this novel compound against Mycobacterium avium , Mycobacterium abscessus , and Mycobacterium chelonae in vitro and in vivo . The minimum inhibitory concentration (MIC) of WX-081 against three kinds of non-tuberculous mycobacteria (NTM) clinical strains was determined using microplate-based alamarBlue assay (MABA), and the antibacterial activity of WX-081 against NTM in J774A.1 cells and mice was evaluated. MIC ranges of WX-081 against clinical strains of M. avium and M. abscessus were 0.05–0.94 μg/mL, 0.88–7.22 μg/mL ( M. abscessus subsp. abscessus ), and 0.22–8.67 μg/mL ( M. abscessus subsp. massiliense ), respectively, which were slightly higher than those of BDQ. For M. avium , M. abscessus , and M. chelonae , WX-081 can reduce the intracellular bacterial load by 0.13–1.18, 0.18–1.50, and 0.17–1.03 log 10 colony forming units (CFU)/mL, respectively, in a concentration-dependent manner. WX-081 has bactericidal activity against three NTM species in mice. WX-081 exhibited anti-NTM activity to the same extent as BDQ both in vivo and in vitro . WX-081 is a promising clinical candidate and should be studied further in clinical trials.

IMPORTANCE:

Due to the rapidly increased cases globally, non-tuberculous mycobacteria (NTM) disease has become a significant public health problem. NTM accounted for 11.57% of all mycobacterial isolates in China, with a high detection rate of Mycobacterium abscessus , Mycobacterium avium , and Mycobacterium chelonae during 2000–2019. Treatment of NTM infection is often challenging, as natural resistance to most antibiotics is quite common among different NTM species. Hence, identifying highly active anti-NTM agents is a priority for potent regimen establishment. The pursuit of new drugs to treat multidrug-resistant tuberculosis may also identify some agents with strong activity against NTM. Sudapyridine (WX-081) is a structural analog of bedaquiline (BDQ), which was developed to retain the anti-tuberculosis efficacy but eliminates the severe side effects of BDQ. This study initially evaluated the antimicrobial activity of this novel compound against M. avium , M. abscessus , and M. chelonae in vitro , in macrophages and mice, respectively.

2023-01-12·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[Annual progress of chemotherapy of multidrug/rifampicin-resistant tuberculosis in 2022].

Review

作者: Yu, J J ; Tang, S J

At present, the number of cases with multidrug/rifampicin-resistant tuberculosis (MDR/RR-TB) in China ranks fourth in the world, and the prevention and control situation is still serious. Chemotherapy, as the most important treatment for MDR/RR-TB, was studied and explored by domestic and foreign researchers in 2022. New chemotherapeutic drugs such as delpazolid, sutezolid, telacebec and independently developed anti-tuberculosis drugs such as pyrifazimine, sudapyridine and JBD0131 are still in clinical trials. The efficacy, safety, tolerability, adverse reactions and drug resistance of bedaquiline, linezolid, delamanid and pretomanid have been studied extensively. Meanwhile, different new chemotherapy regimens centered on new drugs have been explored in-depth by international scholars. In this article, we reviewed the progress of chemotherapy of multidrug/rifampicin-resistant tuberculosis from October 2021 to September.

2023-01-01·Frontiers in cellular and infection microbiology

Antibacterial activity of the novel compound Sudapyridine (WX-081) against Mycobacterium abscessus.

Article

作者: You, Yingxia ; Geng, Ruixue ; Chu, Naihui ; Gao, Shan ; Nie, Wenjuan ; Liu, Lina ; Su, Lei

Objective:

This study aimed to investigate sudapyridine (WX-081) antibacterial activity against Mycobacterium abscessus in vitro and its effect on in vivo bacterial growth and host survival using a zebrafish model of M. abscessus infection.

Methods:

WX-081 in vitro antibacterial activity was assessed based on growth inhibition of M. abscessus standard strain ATCC19977 and 36 clinical isolates. Maximum tolerated concentrations (MTCs) of WX-081, bedaquiline, and azithromycin and inhibition of M. abscessus growth were assessed in vivo after fluorescently labelled bacilli and drugs were injected into zebrafish. Bacterial counts were analysed using one-way ANOVA and fluorescence intensities of zebrafish tissues were analysed and expressed as the mean ± SE. Moreover, Kaplan-Meier survival analysis was conducted to assess intergroup differences in survival of M. abscessus-infected zebrafish treated with different drug concentrations using a log-rank test, with a p value <0.05 indicating a difference was statistically significant.

Results:

Drug sensitivity testing of M. abscessus standard strain ATCC19977 and 36 clinical isolates revealed MICs ranging from 0.12-0.96 µg/mL and MIC₅₀ and MIC₉₀ values of 0.48 µg/mL and 0.96 µg/mL, respectively. Fluorescence intensities of M. abscessus-infected zebrafish tissues was lower after treatment with the WX-081 MTC (62.5 µg/mL) than after treatment with the azithromycin MTC (62.5 µg/mL) and the bedaquiline MTC (15.6 µg/mL). When the concentration of WX-081 increased from 1.95µg/mL to 1/8 MTC(7.81µg/mL), the survival rate of zebrafish at 4-9 dpf decreased from 90.00% to 81.67%.

Conclusion:

WX-081 effectively inhibited M. abscessus growth in vitro and in vivo and prolonged survival of M. abscessus-infected zebrafish, thus indicating that WX-081 holds promise as a clinical treatment for M. abscessus infection.

项与 Sudapyridine 相关的新闻（医药）

2023-07-03

·药智网

效力54%！102年无新疫苗问世，全球首款或将诞生？

近日，比尔及梅琳达·盖茨基金会和惠康基金会宣布将出资5.5亿美元，用于肺结核病候选疫苗M72/AS01E的临床3期试验，该药物主要用于预防青少年及成年人患肺结核病。在此之前，全球只有卡介苗可以用于预防婴儿和幼儿患肺结核病，而卡介苗于1921年问世，而此后102年的时间里，再无一款疫苗可用于预防肺结核病。M72/AS01E临床3期试验如若成功，将成为百年来上市的首款可预防青少年及成年人患肺结核病的疫苗。疫苗效力达54%，M72/AS01E临床2b期结果公布据悉，该候选疫苗由制药公司GSK开发，由M72重组融合蛋白和佐剂AS01组成。目前该疫苗已经完成临床2期试验，并即将进入临床3期阶段。有效性方面，临床2b试验结果显示，接受M72/AS01E的参与者有10名符合病例定义，即感染了肺结核，相比之下，安慰剂组有22名参与者符合病例定义，所以疫苗效力为54%。M72/AS01与安慰剂效力对比图片来源：参考文献1安全性方面，在注射后30天内，M72/AS01E组(67.4%)比安慰剂组(45.4%)有更多的不良事件报告，差异主要为注射部位反应和流感样症状，其中两组中-严重不良事件，但是潜在免疫介导疾病和死亡的发生概率相似。以上的临床2期试验结果表明，M72/AS01E在预防肺结核病方面的潜力极高，它有可能成为近一个世纪以来，在全球范围内首个可有效预防青少年及成年人患肺结核病的疫苗。据资料显示，卡介苗是目前唯一得到批准的肺结核病疫苗。虽然它在预防婴幼儿重症肺结核病方面具有中等效力，但不能充分保护青少年和成人，而这两个人群占全球肺结核病传播的近90%。据世卫组织委托进行的一项研究《肺结核病新疫苗投资论证》估计，在25年内，一种在青少年和成人中预防疾病有效率达到50%的疫苗可以避免多达7600万例肺结核病新发病例、850万例死亡、4200万个抗生素疗程和受肺结核病影响家庭面临的65亿美元费用。有效率达到75%的疫苗则可以避免多达1.1亿例新发病例和1230万例死亡。该研究进一步表明，在50%有效疫苗上每投资1美元，就可以在避免卫生成本和提高生产力方面产生7美元的经济效益。所以若M72/AS01E疫苗能最终上市，将大幅度减少肺结核新发病例以及死亡病例，同时产生的经济效益更是多达几百亿元，回报率将是投入的7倍左右。肺结核患者全球超1000万例，每年花费130亿美元据世界卫生组织估计，全球约有四分之一的人口已经感染肺结核杆菌，其中大约5%-10%的肺结核病感染者最终会出现症状并发展为肺结核病。据世界卫生组织发布的《2022年全球肺结核病报告》估算，2021年全世界约有1060万人感染肺结核病，其中600万名男性、340万名女性和120万名儿童，2021年共有160万人死于肺结核病。据世界卫生组织统计，约87%的肺结核病新发病例发生在30个肺结核病高负担国家，占全球总数三分之二以上的新发病例发生在孟加拉国、中国、刚果民主共和国、印度、印度尼西亚、尼日利亚、巴基斯坦和菲律宾，我国当前肺结核患病人数高居世界前三位。下表为我国近年来肺结核新发病例数量以及死亡人数。表1 近年我国肺结核发病及死亡人数数据来源：中国卫健委官网近年来，我国肺结核病的流行率整体呈下降趋势，2008年我国肺结核发病人数1169540例，而2021年发病人数降为639548例，在13年的时间里我国肺结核发病人数降低45%，但整体基数依旧较大。而如此庞大肺结核患病群体也为国家的医疗体系带来了沉重的负担。如此巨大的患病群体必然会产生较大的药物市场，据世界卫生组织估算，每年大概需要130亿美元用于肺结核病预防、诊断、治疗和护理。肺结核药物及全球新药在研情况当前用于治疗肺结核的药物具有多种，其中作为一线治疗药物的有异烟肼、利福平、吡嗪酰胺、乙胺丁醇以及链霉素等药物，但是上述的几种药物作为第一代治疗肺结核药物，如若作为常规的肺结核病治疗药物是有效的，但是一旦遇到耐多药肺结核病，情况则变得复杂多变。耐多药肺结核病对异烟肼和利福平等一线治疗肺结核病药物均无反应，在此情况下，新一代肺结核药物诞生了，包括我们熟知的德拉马尼、富马酸贝达喹啉以及普托马尼，都是近年来上市用于治疗耐多药肺结核病有效的良药。除上述几款药物外，当前全球有超7款药物处于临床阶段，详见下表。表2 临床阶段治疗肺结核药物数据来源：.clinicaltrials.gov及chinadrugtrials其中，最值得关注的当属上海嘉坦医药所研发的WX-081片，该药物是我国自主研发的1类新药，当前已处于临床3期。其最初由辰欣药业研发，后辰欣药业将专利申请、专有技术、知识产权及其他权益转让给了上海嘉坦医药。目前，该企业暂时未公布WX-081片临床2期试验结果，WX-081片若是能够最终上市，将造福千万肺结核病患者，减轻国家医疗负担。小结创新医药研发是终止疾病的战略支柱之一，正如疫苗M72/AS01E，如若最终能上市，将减少大约7600万青少年及成年人肺结核病新发病例，从源头切断疾病的传染，才是最为有效的办法。参考文献：[1]Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis.[2]WHO官网、国家卫健委官网.声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八角转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是昨天最受欢迎的文章哦

疫苗临床3期临床结果临床2期临床1期

2023-06-07

·医药观澜

嘉越医药完成逾亿元pre-C轮融资，推进重点品种2/3期临床开发

▎药明康德内容团队报道6月7日，嘉越医药宣布完成由成都生物城基金（国生资本）、安信国生微芯基金、勤智资本共同参与的逾亿元pre-C轮融资。本轮融资将用于该公司创新药管线多个中后期临床项目的推进，特别是针对全球重大公共卫生问题和传染性疾病领域的创新药物临床3期，以及肿瘤、自身免疫等多个疾病领域临床2期项目的开发。公开资料显示，嘉越医药是一家专业从事创新药研发的生物医药公司，重点关注肿瘤和自身免疫、代谢类和感染性等疾病领域。通过其转化医学平台，该公司团队陆续将具有临床开发价值的候选化合物（PCC）开发成为经临床2期有效性和安全性验证（PoC）的临床药物，以期为患者提供具有临床价值的产品。目前，嘉越医药已拥有多个创新药项目，多个临床试验正同步推进中。其中，1类创新药舒达吡啶（WX-081）片已于近期启动一项多中心、随机、双盲、阳性药物对照的3期临床研究全国研究者会议，治疗利福平耐药的肺结核患者。嘉越医药在新闻稿中表示，在原有股东的长期支持下，他们非常荣幸新股东成都生物城基金（国生资本）、安信国生微芯基金、勤智资本的加入。期待在新老股东的共同扶持下，嘉越医药依托完善的创新药研发团队，以“致力临床转化、创新临床价值”为使命，赋能健康，造福患者。国生资本投资团队表示，嘉越医药拥有一支复合型资深团队，通过高效的转化医学平台，团队深挖靶点、机制和疾病科学根基，多个重点品种已进入临床3期和2期，覆盖及扩展的适应症众多且在同领域中进展较快，已构成了梯度搭配的产品管线。期待嘉越医药能为患者提供未被满足的真正具有临床价值的更安全、更有效、更经济的产品。安信国生微芯基金投资团队表示，嘉越医药是一家以临床转化和临床医学为核心驱动的创新药平台型公司，专注于全球重大传染病、恶性肿瘤、自身免疫及代谢等临床亟需疾病领域，已有多个重点品种进入临床3期和2期阶段。该公司通过对疾病致病机理和药物起效机制的深入研究，针对不同疾病和药物寻找特异性的肿瘤标记物，从而实现药物临床的差异化开发和新适应症的发掘。相信在该公司富有经验的核心研发团队的带领下，嘉越医药将开发出真正具有临床价值的创新药物。勤智资本管理合伙人郑振华先生表示，非常荣幸有机会参与本轮融资，他们与嘉越医药的创始团队相知相识多年，在本次投资前，勤智资本跟进该公司有四年多的时间，见证了嘉越医药的成长壮大的历程。该公司团队务实、执行效率高、创业精神令人感动！嘉越医药致力于肿瘤、自免、代谢和感染疾病领域的创新药研发，形成了风险平衡的产品梯队，依靠其转化医学平台建立了差异化优势，能够更好地解决未被满足的临床需求，期待嘉越医药产品早日上市，造福更多患者。参考资料：[1]嘉越医药宣布完成逾亿元pre-C轮融资. Retrieved Jun 7, 2023, from https://mp.weixin.qq.com/s/r545pcjzIp12gnWeMzX0Pw本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。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。

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100 项与 Sudapyridine 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
肺结核	临床3期	中国	辰欣药业股份有限公司	2022-08-29
多重耐药性肺结核	临床2期	中国	上海嘉坦医药科技有限公司	2020-10-16
利福平耐药结核病	临床1期	-	上海嘉坦医药科技有限公司	2024-12-12