IP Library › Granted Patent US 12,533,375
Granted Patent B2
US 12,533,375 · App. 18/588,605 · Granted Jan 27, 2026

Compositions and methods of use thereof

Inventors: Shenda M. Baker (Upland, CA); William P. Wiesmann (Chevy Chase, MD); Stacy Marie Townsend (Rancho Cucamonga, CA)
Assignee: SYNEDGEN, INC.
A61K31/726A61K9/0078A61K9/08A61K9/14A61K9/48A61K45/06A61K47/10
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Quick Facts
Patent No.
US 12,533,375
App. No.
18/588,605
Granted
Jan 27, 2026
Kind
B2
Abstract

Described herein are methods for treating or preventing a disease or disorder of the pulmonary system (e.g., cystic fibrosis), respiratory or digestive system in a subject, the methods comprising administering compounds or compositions comprising water soluble polyglucosamine and derivatized polyglucosamine.

Claims (35)

1 . A method for treating a subject suffering from a pulmonary disease or disorder, comprising administering to the subject an effective amount of a nebulizer solution composition configured for inhaled administration comprising:

a neutral osmol agent; and

a poly (acetyl, arginyl) glucosamine (PAAG) comprising the following formula (I):

wherein:

n is an integer between 20 and 6000; and

each R 1 is independently selected for each occurrence from hydrogen, acetyl,

wherein at least 25% of R 1 substituents are H, at least 1% of R 1 substituents are acetyl, and at least 2% of R 1 substituents are

wherein the osmolality of the composition is between 150-550 mOsmol/kg;

wherein the method improves mucociliary transport or clearance, thereby treating the pulmonary disease or disorder; and

wherein the neutral osmol agent is selected from the group consisting of glycerol, sorbitol, mannitol, erythritol, and trehalose.

2 . The method of claim 1 , wherein the average molecular weight of the PAAG is from 20 to 150 kDa.

3 . The method of claim 1 , wherein the average molecular weight of the PAAG is from 70 to 120 kDa.

4 . The method of claim 1 , wherein the polydispersity index of the PAAG is from 1.0 to 2.5.

5 . The method of claim 1 , wherein the pH of the composition is about 7 to about 8.

6 . The method of claim 1 , wherein the PAAG is arginine-functionalized at between 20%-30%.

7 . The method of claim 1 , wherein the neutral osmol agent is glycerol.

8 . The method of claim 7 , wherein the glycerol is present in the composition at between 1.2-1.4% v/v.

9 . A nebulizer solution composition configured for inhaled administration, comprising:

a poly (acetyl, arginyl) glucosamine (PAAG) comprising the following formula (I):

wherein:

n is an integer between 20 and 6000; and

each R 1 is independently selected for each occurrence from hydrogen, acetyl,

wherein at least 25% of R 1 substituents are H, at least 1% of R 1 substituents are acetyl, and at least 2% of R 1 substituents are

 and

a neutral osmol agent selected from the group consisting of glycerol, sorbitol, mannitol, erythritol, and trehalose,

wherein the osmolality of the composition is between 150-550 mOsmol/kg.

10 . The composition of claim 9 , wherein the average molecular weight of the PAAG is from 20 to 150 kDa.

11 . The composition of claim 9 , wherein the average molecular weight of the PAAG is from 70 to 120 kDa.

12 . The composition of claim 9 , wherein the average molecular weight of the PAAG is from 50 to 90 kDa.

13 . The composition of claim 9 , wherein the polydispersity index of the PAAG is from 1.0 to 2.5.

14 . The composition of claim 9 , wherein the pH of the composition is about 7 to about 8.

15 . The composition of claim 9 , wherein the PAAG is arginine-functionalized at between 20%-30%.

16 . The composition of claim 9 , wherein the neutral osmol agent is glycerol.

17 . The composition of claim 16 , wherein the glycerol is present in the composition at between 1.2-1.4% v/v.

18 . The composition of claim 9 , wherein the PAAG is present in the composition at between 0.1-2 mg/ml.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2024
From: BAKER, SHENDA; WIESMANN, WILLIAM P.; TOWNSEND, STACY MARIE
To: SYNEDGEN, INC.
Reel/Frame 066885/0745 →
Continuity (4)
Continuation 16573559 · Sep 17, 2019
Continuation 15510478
Provisional Application 62049082 · Sep 11, 2014
Related Publication 20240350529A1 · Oct 24, 2024
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