Compositions and methods for treating, ameliorating and preventing H. pylori infections

Inventors

Borody, Thomas Julius

Assignees

Centre for Digestive Diseases Pty Ltd

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Publication Number

US-11833140-B2

Patent

Publication Date

2023-12-05

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

A therapeutic combination of drugs is described for treating or preventing Helicobacter pylori infection. The combination includes a composition comprising vonoprazan or a vonoprazan fumarate, or specified vonoprazan fumarate derivatives, formulated for administration to an individual in need thereof at specified doses and twice daily or three times daily administration frequencies, or at a unit dosage of at least about 100 mg administered at least once a day.

The therapeutic combination further includes an antimicrobial or antibiotic drug or composition comprising amoxicillin and rifabutin. The approach centers on pairing a vonoprazan-based composition with an amoxicillin plus rifabutin antimicrobial regimen.

The description additionally provides multiple therapeutic combination embodiments and supporting regimens that include alternative or additional antimicrobial pairings and adjunct compounds alongside the vonoprazan-centered therapy. Documented examples include combinations that incorporate amoxicillin with clarithromycin, metronidazole, rifabutin, or fluoroquinolones, and optional additional agents such as bismuth, furazolidone, and nitazoxanide.

Claims Coverage

The provided material identifies one independent claim, with coverage that centers on an explicitly specified therapeutic combination including a vonoprazan component plus an antimicrobial regimen comprising amoxicillin and rifabutin, together with specified vonoprazan dosing and administration frequency.

Vonoprazan component with specified vonoprazan fumarate forms or derivatives

A composition comprising vonoprazan or a vonoprazan fumarate, or a specified vonoprazan fumarate derivative is formulated for administration to the individual in need thereof at a dose of between 50 mg to about 200 mg or more twice daily or three times daily, or at a unit dosage of at least about 100 mg administered at least once a day.

Amoxicillin dose range combined with rifabutin antimicrobial component

An antimicrobial or antibiotic drug or composition comprising amoxicillin formulated at a dose of between about 250 gm to about 1 g and rifabutin is provided in combination with the vonoprazan component.

The main inventive coverage is the pairing of a vonoprazan composition with an antimicrobial regimen comprising amoxicillin and rifabutin, together with specified vonoprazan dosing and bid/tid administration or at least once daily unit dosing.

Stated Advantages

Improved eradication efficacy for Helicobacter pylori infection, including near-100% eradication in some contexts.

Reduced resistance.

Documented Applications

Treating or preventing Helicobacter pylori infection in an individual in need thereof.

An example patient case using adjunct Bifidobacterium infantum and a multi-drug regimen with a negative urea breath test after therapy.

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