Compositions and methods for treating, ameliorating and preventing H. pylori infections
Inventors
Assignees
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Publication Number
US-11033536-B2
Publication Date
2021-06-15
Expiration Date
Abstract
Provided are methods for treating, ameliorating, reversing and/or preventing a Helicobacter pylori (H. pylori) infection in an individual in need thereof, comprising: administering to the individual in need thereof a therapeutic combination comprising: (a) a composition comprising or consisting of: vonoprazan or a vonoprazan fumarate, or a 5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine monofumarate, or a 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methyl-methanamine fumarate), optionally TAKECAB™; and (b) an antimicrobial or antibiotic drug or composition.
Core Innovation
The invention relates to a method for treating, ameliorating, reversing and/or preventing, or acting as a prophylaxis, a Helicobacter pylori infection in an individual in need thereof. The method comprises administering a combination of drugs that includes a composition comprising vonoprazan, vonoprazan fumarate, or specified vonoprazan-related compounds and an antimicrobial/antibiotic drug composition including amoxicillin and rifabutin.
The core drug combination uses vonoprazan or specified vonoprazan salts/related compounds together with an antimicrobial regimen defined by amoxicillin and rifabutin. The disclosure defines administration for the antimicrobial component and for the vonoprazan component according to specified dose and dosing frequency options, and presents the interaction of these components as the basis for treating, ameliorating, reversing, preventing, and/or prophylaxis of H. pylori infection.
The disclosure also describes additional formulation and adjunct options for the drug regimen, including delayed or enteric release and microencapsulation/prolonged-release type approaches. Optional therapeutic entities include probiotics, including Bifidobacterium infantum, prebiotics, biofilm-disrupting compounds, statins, and pronase, and a clinical example is described showing eradication after failure using a vonoprazan-based multi-drug regimen with Bifidobacterium infantum.
Claims Coverage
The relevant independent claim is clm-00001. It recites one main inventive combination: a vonoprazan component together with an antimicrobial regimen including amoxicillin and rifabutin, for treating, ameliorating, reversing, preventing, and/or prophylaxis of an H. pylori infection, with defined dose and frequency parameters for the vonoprazan component and the amoxicillin component.
Vonoprazan-based H. pylori treatment with amoxicillin plus rifabutin
A method for treating, ameliorating, reversing and/or preventing, or acting as a prophylaxis, a Helicobacter pylori infection, comprising administering to an individual in need thereof a drug combination including a composition comprising or consisting of vonoprazan or a vonoprazan fumarate or specified vonoprazan-related compounds, and an antimicrobial/antibiotic drug composition comprising amoxicillin and a rifabutin component, wherein the vonoprazan composition and amoxicillin are administered according to specified dose and dosing frequency options.
The independent claim covers a vonoprazan composition plus an antibiotic regimen defined by amoxicillin together with rifabutin for treating, ameliorating, reversing and/or preventing H. pylori infection or acting as prophylaxis, with specified dosing and frequency options.
Stated Advantages
Eradication of Helicobacter pylori infection is described in a clinical example after failure with a vonoprazan-based multi-drug regimen including Bifidobacterium infantum.
The method provides treatment, amelioration, reversal, prevention, and/or prophylaxis actions for Helicobacter pylori infection.
Documented Applications
Treating, ameliorating, reversing, preventing, or acting as prophylaxis for a Helicobacter pylori (H. pylori) infection in an individual in need thereof.
Clinical example of eradication after failure using a vonoprazan-based multi-drug regimen including Bifidobacterium infantum.
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