Compositions and methods of use thereof

Inventors

Baker, Shenda M. • Wiesmann, William P.

Assignees

Synedgen Inc

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Publication Number

US-12533374-B2

Patent

Publication Date

2026-01-27

Expiration Date


Abstract

Described herein are methods of treating a Nontuberculosis Mycobacteria (NTM) infection in a subject in need thereof, the methods comprising administering an effective amount of a polyglucosamine derivative or a composition comprising a polyglucosamine derivative.

Core Innovation

The disclosure relates to treating acute or chronic nontuberculosis mycobacteria (NTM) infection by administering an effective amount of a poly(acetyl, arginyl) glucosamine (PAAG) comprising Formula (I). The PAAG is defined by an integer n between 20 and 6000, with each R1 independently selected from hydrogen, acetyl, and an arginyl-containing substituent.

The polymer composition requires at least 25% of R1 substituents as H, at least 1% of R1 substituents as acetyl, and at least 2% of R1 substituents as the arginyl-containing substituent. This constrained PAAG composition is administered to a subject in need thereof, including a subject unresponsive to a previously administered NTM therapy.

The disclosure further targets clinical outcomes described as achieving a negative NTM cell sputum culture of the subject, or producing an undetectable amount of NTM cells in the subject. It also includes eradicating an entire population of NTM cells in environments selected from a subject, a sample, a biofilm, a surface, and a medical device.

Claims Coverage

The dataset provides three independent method claims. Across these claims, the main inventive features are the defined PAAG composition with quantitative R1 constraints and n range, and the specified treatment or eradication outcomes.

Formula (I) PAAG composition with n and R1 percentage constraints

The method administers an effective amount of a poly(acetyl, arginyl) glucosamine (PAAG) comprising Formula (I), wherein n is an integer between 20 and 6000, each R1 is independently selected from hydrogen, acetyl, and the arginyl-containing substituent, and the polymer has at least 25% of R1 substituents as H, at least 1% as acetyl, and at least 2% as the arginyl-containing substituent.

Treating acute or chronic NTM infection with negative NTM cell sputum culture

A method of treating an acute or chronic nontuberculosis mycobacteria (NTM) infection in a subject in need thereof, where the subject is unresponsive to a previously administered NTM therapy and the treatment comprises achieving a negative NTM cell sputum culture of the subject.

Treating unresponsive acute or chronic NTM infection with undetectable NTM cells

A method of treating an acute or chronic nontuberculosis mycobacteria (NTM) infection in a subject in need thereof, where the subject is unresponsive to a previously administered NTM therapy and the treatment results in an undetectable amount of NTM cells in the subject.

Eradicating an entire population of NTM cells in defined environments

A method of eradicating an entire population of nontuberculosis mycobacteria (NTM) cells in an environment selected from the group consisting of a subject, a sample, a biofilm, a surface, and a medical device, by administering an effective amount of PAAG comprising Formula (I) with n between 20 and 6000 and R1 percentage constraints.

The claim set is centered on administering a PAAG polyglucosamine derivative defined by Formula (I) with an n range and quantitative R1 composition constraints, combined with outcomes including a negative NTM cell sputum culture, an undetectable amount of NTM cells in an unresponsive subject, and eradication of an entire NTM cell population in specified environments.

Stated Advantages

Achieving a negative NTM cell sputum culture of the subject.

Producing an undetectable amount of NTM cells in the subject.

Eradicating an entire population of NTM cells in environments selected from a subject, a sample, a biofilm, a surface, and a medical device.

Documented Applications

Treating acute or chronic nontuberculosis mycobacteria (NTM) infection in a subject in need thereof, including subjects unresponsive to a previously administered NTM therapy.

Eradicating an entire population of NTM cells in an environment selected from a subject, a sample, a biofilm, a surface, and a medical device.

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