Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Rifasutenizol (TNP 2198) in Combination With Rabeprazole and Amoxicillin in the Primary Treatment of Participants With H. Pylori Infection

A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation.
Subjects will be randomly assigned to test group or control group at a 1:1 ratio stratified by study site, and will receive Rifasutenizol capsules, rabeprazole sodium enteric-coated tablets, amoxicillin capsules combined with clarithromycin placebo tablets and bismuth potassium citrate placebo capsules (test group), or bismuth-containing quadruple regimen of amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets and bismuth potassium citrate capsules combined with RSZ placebo capsules (control group) for 14 consecutive days.
13C UBT will be performed 4 6 weeks after the last dose to evaluate the eradication effect of H. pylori.

Start Date18 May 2023

Sponsor / Collaborator

TenNor Therapeutics Suzhou Ltd.

CTR20230576 / CompletedPhase 3

评价TNP-2198联合雷贝拉唑钠和阿莫西林在初次治疗幽门螺杆菌感染人群中有效性及安全性的多中心、随机、双盲、铋剂四联阳性对照III期临床研究

[Translation] A multicenter, randomized, double-blind, bismuth-based quadruple positive-controlled phase III clinical study to evaluate the efficacy and safety of TNP-2198 combined with rabeprazole sodium and amoxicillin in the first-time treatment of Helicobacter pylori infection

主要目的评价TNP-2198联合雷贝拉唑钠和阿莫西林初次治疗幽门螺杆菌感染的根除率是否非劣于铋剂四联方案（若非劣效结论成立，将进一步评估是否优于铋剂四联方案）。次要目的基于幽门螺杆菌培养及药敏试验结果，评价TNP-2198联合雷贝拉唑钠和阿莫西林初次治疗幽门螺杆菌感染的有效性；评价TNP-2198联合雷贝拉唑钠和阿莫西林初次治疗幽门螺杆菌感染的安全性；评价TNP-2198在联合雷贝拉唑钠、阿莫西林给药中的药代动力学特征。

[Translation]

Main purpose To evaluate whether the eradication rate of TNP-2198 combined with rabeprazole sodium and amoxicillin in the initial treatment of Helicobacter pylori infection is non-inferior to the bismuth quadruple regimen (if the non-inferiority conclusion is established, whether it is superior to the bismuth quadruple regimen will be further evaluated). Secondary purpose Based on the results of Helicobacter pylori culture and drug sensitivity tests, evaluate the effectiveness of TNP-2198 combined with rabeprazole sodium and amoxicillin in the initial treatment of Helicobacter pylori infection; To evaluate the safety of TNP-2198 combined with rabeprazole sodium and amoxicillin in the initial treatment of Helicobacter pylori infection; To evaluate the pharmacokinetic characteristics of TNP-2198 in combination with rabeprazole sodium and amoxicillin.

Start Date06 May 2023

Sponsor / Collaborator

TenNor Therapeutics Suzhou Ltd.

NCT06137573 / CompletedPhase 1

A Clinical Study of Absorption, Metabolism and Excretion of [14C]TNP-2198 in Healthy Adult Male Participants- Human Mass Balance and Biotransformation Study of [14C]TNP-2198

The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants

Start Date12 Jul 2022

Sponsor / Collaborator

TenNor Therapeutics Suzhou Ltd.

100 Clinical Results associated with Rifasutenizol

100 Translational Medicine associated with Rifasutenizol

100 Patents (Medical) associated with Rifasutenizol

Literatures (Medical) associated with Rifasutenizol

01 May 2022·Current Medicinal ChemistryQ2 · MEDICINE

A Comparative Insight on the Newly Emerging Rifamycins: Rifametane, Rifalazil, TNP-2092 and TNP-2198

Q2 · MEDICINE

Review

Author: Nazli, Adila ; He, Yun ; Xu, Huacheng ; Wang, Zhi-Peng ; He, David L

Abstract::

Rifamycins are considered a milestone for tuberculosis (TB) treatment because of their proficient sterilizing ability. Currently, available TB treatments are complicated and need a long duration, which ultimately leads to failure of patient compliance. Some new rifamycin derivatives, i.e., rifametane, TNP-2092 (rifamycin-quinolizinonehybrid), and TNP-2198 (rifamycin-nitromidazole hybrid) are under clinical trials, which are attempting to overcome the problems associated with TB treatment. The undertaken review is intended to compare the pharmacokinetics, pharmacodynamics and safety profiles of these rifamycins, including rifalazil, another derivative terminated in phase II trials, and already approved rifamycins. The emerging resistance of microbes is an imperative consideration associated with antibiotics. Resistance development potential of microbial strains against rifamycins and an overview of chemistry, as well as structure-activity relationship (SAR) of rifamycins, are briefly described. Moreover, issues associated with rifamycins are discussed as well. We expect that newly emerging rifamycins shall appear as potential tools for TB treatment in the near future.

24 Mar 2022·Journal of medicinal chemistryQ1 · MEDICINE

Design, Synthesis, and Characterization of TNP-2198, a Dual-Targeted Rifamycin-Nitroimidazole Conjugate with Potent Activity against Microaerophilic and Anaerobic Bacterial Pathogens

Q1 · MEDICINE

Article

Author: Wang, Huan ; Ma, Zhenkun ; Molodtsov, Vadim ; Ding, Charles ; He, Shijie ; Liu, Yu ; Yuan, Ying ; Weiss, William J. ; Zhuang, Zhijun ; Xu, Xiangyi ; Nguyen, Phung ; Lin, Wei ; Duncan, Leonard ; Pulse, Mark ; Lynch, Anthony Simon ; Robertson, Gregory T. ; Ebright, Richard H. ; Doyle, Timothy ; Chen, Jing

TNP-2198, a stable conjugate of a rifamycin pharmacophore and a nitroimidazole pharmacophore, has been designed, synthesized, and evaluated as a novel dual-targeted antibacterial agent for the treatment of microaerophilic and anaerobic bacterial infections. TNP-2198 exhibits greater activity than a 1:1 molar mixture of the parent drugs and exhibits activity against strains resistant to both rifamycins and nitroimidazoles. A crystal structure of TNP-2198 bound to a Mycobacterium tuberculosis RNA polymerase transcription initiation complex reveals that the rifamycin portion of TNP-2198 binds to the rifamycin binding site on RNAP and the nitroimidazole portion of TNP-2198 interacts directly with the DNA template-strand in the RNAP active-center cleft, forming a hydrogen bond with a base of the DNA template strand. TNP-2198 is currently in Phase 2 clinical development for the treatment of Helicobacter pylori infection, Clostridioides difficile infection, and bacterial vaginosis.

Biomedicines

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects

Review

Author: Imran, Mohd. ; Elmigdadi, Fayig ; Hudu, Shuaibu Abdullahi ; Alshrari, Ahmed S.

Clostridioides difficile infection (CDI) is an urgent threat and unmet medical need. The current treatments for CDI are not enough to fight the burden of CDI and recurrent CDI (r-CDI). This review aims to highlight the future drugs for CDI and their related patented applications. The non-patent literature was collected from PubMed and various authentic websites of pharmaceutical industries. The patent literature was collected from free patent databases. Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons. The patent literature reveals some important inventions for the existing treatments of CDI and supports the possibility of developing more and better CDI-treatment-based inventions, including patient-compliant dosage forms, targeted drug delivery, drug combinations of anti-CDI drugs possessing diverse mechanisms of action, probiotic and enzymatic supplements, and vaccines. The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI.

News (Medical) associated with Rifasutenizol

27 Feb 2024

·www.businesswire.com

Helicobacter Pylori Infection Pipeline Insight Report 2024: Insights About 5+ Companies and 5+ Pipeline Drugs Featuring TenNor Therapeutics, Servatus Biopharmaceuticals, and TenNor Therapeutics - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Helicobacter Pylori Infection - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Helicobacter Pylori Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Helicobacter Pylori Infection R&D. The therapies under development are focused on novel approaches to treat/improve Helicobacter Pylori Infection. Helicobacter Pylori Infection Emerging Drugs Chapters This segment of the Helicobacter Pylori Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Helicobacter Pylori Infection Emerging Drugs TNP-2198: TenNor Therapeutics (Suzhou) Limited Rifasutenizole (TNP-2198) is a new molecule entity discovered and developed by TenNor specifically for the treatment of H. pylori infection. Its multi-targeting synergistic mechanism delivers low drug resistance frequencies, maintaining excellent bactericidal activities against H. pylori strains isolated from various regions. Rifasutenizole has the potential to streamline the eradication regimes of H. pylori so as to improve the compliance and enable a seamless connection to the urea breath test (UBT), rendering the possibility of carrying out screening-eradication on large scale. TenNor is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III study to evaluate the efficacy and safety of Rifasutenizole in the primary treatment of patients with H. pylori infection. SVT1C4610: Servatus Biopharmaceuticals SVT1C4610 is a live biotherapeutic type of drug. Its mechanism include Bacteria replacements, gastrointestinal microbiome modulators. Its main therapeutic area is infectious disease control. Currently, the drug is in phase I stage of its clinical trial for the treatment of H. pylori infection. Major Players in Helicobacter Pylori Infection There are approx. 5+ key companies which are developing the therapies for Helicobacter Pylori Infection. The companies which have their Helicobacter Pylori Infection drug candidates in the most advanced stage, i.e. Phase III include, TenNor Therapeutics (Suzhou) Limited. Helicobacter Pylori Infection: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Helicobacter Pylori Infection therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Helicobacter Pylori Infection drugs. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Helicobacter Pylori Infection Report Insights Helicobacter Pylori Infection Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Helicobacter Pylori Infection Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players TenNor Therapeutics (Suzhou) Limited Servatus Biopharmaceuticals TenNor Therapeutics Inc. Key Products TNP-2198 SVT-1C4610 TNP-2092 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ck4nzd About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 3Phase 1Phase 2Gene Therapy

100 Deals associated with Rifasutenizol

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anaerobic bacterial infection	Phase 3	CN	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Bacterial Vaginosis	Phase 3	CN	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Clostridium difficile diarrhea	Phase 3	CN	TenNor Therapeutics Suzhou Ltd.	06 May 2023
digestive infection	Phase 3	CN	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Helicobacter pylori infection	Phase 3	CN	TenNor Therapeutics Suzhou Ltd.	06 May 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06076694 (CTgov)	Phase 2	Helicobacter pylori infection	80	TNP-2198+Amoxicillin+Rabeprazole Sodium (Group A)	lsqxxhridv(wduuifnyby) = tzlukhnlsq mdcaxsbjjr (plxcfrhqja, iabiacnskw - fhgwkzmqhm) View more	-	12 Dec 2023
				TNP-2198+Amoxicillin+Rabeprazole Sodium (Group B)	lsqxxhridv(wduuifnyby) = zuxriinvfb mdcaxsbjjr (plxcfrhqja, dkfglcigdd - lnkwwnzrnt) View more
NCT06076681 (CTgov)	Phase 1/2	Helicobacter pylori infection	40	TNP-2198+Rabeprazole Sodium (Group A)	jgbmudndbh(ikremubrqi) = ptagjpeegc wbndxxsqdn (xqmrijcqsq, thymsmprgp - efebircygl) View more	-	22 Nov 2023
				TNP-2198+Rabeprazole Sodium (Group B)	jgbmudndbh(ikremubrqi) = cxlvipiuje wbndxxsqdn (xqmrijcqsq, wrkvlexycb - kqfxkqnybg) View more

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