Methods for preventing or treating H. pylori infection
Inventors
Ma, Zhenkun • GENG, Guozhu • Chen, Jing • Liu, Yu • XU, Xiangyi • AI, Changlin • Zhang, Junlei • Song, Ting • Zhao, Shuangshuang
Assignees
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Publication Number
US-12005050-B2
Publication Date
2024-06-11
Expiration Date
Abstract
The present disclosure provides methods, drug combinations and kits for treating, ameliorating, reversing and/or preventing a Helicobacter pylori (H. pylori) infection in a patient in need thereof.
Core Innovation
The invention relates to a method for treating, ameliorating, and/or reversing a Helicobacter pylori (H. pylori) infection in a patient in need thereof by administering compound I, an additional antibiotic, and an acid blocker (proton pump inhibitor, PPI). The disclosed regimen centers on 4-Deoxy-3,4-(1H)-imidazo-(2,5-dihydro)rifamycin (Formula 1/2/3/S stereospecific variants) together with an acid-blocking agent and an additional antibiotic.
The background and summary content describe combination therapy that includes an antibiotic component and an acid blocker, with the acid blocker as a PPI administered at an effective dose and the additional antibiotic as an effective amount. Amoxicillin is identified as an example additional antibiotic used in the regimen for 7-14 days, and the content further indicates options for selecting particular PPIs and for formulation choices such as an enteric-coated tablet.
The partial content also describes documented embodiments supporting the regimen, including clinical Example 1 assessing pharmacokinetics and safety in asymptomatic H. pylori-positive subjects and evaluating efficacy by 13C/14C urea breath testing. Example 2 reports high eradication efficacy with safety/PK methodology, and Example 3 compares dissolution profiles of compound I tablets versus capsules, reporting improved dissolution associated with a formulation component such as Tween-80.
Claims Coverage
Two independent claims are identified. Across them, the claims share the core inventive combination of compound I with an acid blocker (PPI) and an additional antibiotic, with specific dosing schedules and treatment duration recited for the method claim, and a product-combination framing recited for the drug-combination claim.
Treating H. pylori infection with compound I plus additional antibiotic and PPI
Administering to a patient in need thereof an effective amount of compound I (4-Deoxy-3,4-(1H)-imidazo-(2,5-dihydro)rifamycin) or a pharmaceutically acceptable salt, together with an effective amount of an additional antibiotic and an effective amount of an acid blocker, wherein the acid blocker is a proton pump inhibitor (PPI) and the additional antibiotic is amoxicillin.
Drug combination with compound I, PPI and amoxicillin
A drug combination comprising an effective amount of compound I (4-Deoxy-3,4-(1H)-imidazo-(2,5-dihydro)rifamycin) or a pharmaceutically acceptable salt, an effective amount of an acid blocker that is a proton pump inhibitor (PPI), and an effective amount of an additional antibiotic wherein the additional antibiotic is amoxicillin, with compound I defined as a compound of Formula 2.
The independent claims cover a treatment method for H. pylori infection using compound I in combination with amoxicillin and a PPI acid blocker, and a drug-combination product comprising the same core components, with compound I defined by Formula 2.
Stated Advantages
High eradication efficacy is reported in the partial content.
Safety/tolerability is evaluated and reported in the partial content.
Improved dissolution profiles are reported for compound I tablet formulations versus capsules in the partial content.
Documented Applications
Treating, ameliorating, and/or reversing Helicobacter pylori (H. pylori) infection in a patient in need thereof using compound I with an acid blocker (PPI) and an additional antibiotic, exemplified with amoxicillin.
Clinical evaluation in asymptomatic H. pylori-positive subjects using pharmacokinetics and safety assessments and efficacy assessment by 13C/14C urea breath testing.
Larger trial cohort evaluation of eradication efficacy and safety/PK methodology.
Formulation/dissolution comparison of compound I tablets versus capsules, including dissolution profile reporting.
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