IP Library › Granted Patent US 12,616,708
Granted Patent B2
US 12,616,708 · App. 18/940,508 · Granted May 5, 2026

Methods for treating pulmonary non-tuberculous mycobacterial infections

Inventors: Gina Eagle (Bridgewater, NJ); Renu Gupta (Bridgewater, NJ)
Assignee: Insmed Incorporated
A61K31/7036A61K9/0019A61K9/0053A61K9/0078A61K9/127A61K31/133A61K31/407A61K31/4375A61K31/4409A61K31/4709A61K31/496A61K31/5383A61K31/546A61K31/65A61K31/7048A61K31/7052A61K45/06A61P31/04
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Quick Facts
Patent No.
US 12,616,708
App. No.
18/940,508
Granted
May 5, 2026
Kind
B2
Abstract

Provided herein are methods for treating a pulmonary infection in a patient in need thereof, for example, a nontuberculous mycobacterial pulmonary infection for at least one treatment cycle. The method comprises administering to the lungs of the patient a pharmaceutical composition comprising a liposomal complexed aminoglycoside comprising a lipid component comprising electrically neutral lipids and an aminoglycoside. Administration comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free aminoglycoside and liposomal complexed aminoglycoside, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient. The methods provided herein result in a change from baseline on the semi-quantitative scale for mycobacterial culture for a treated patient, and/or NTM culture conversion to negative during or after the administration period.

Claims (23)

1 . A method for treating a Mycobacterium avium complex (MAC) lung infection in a patient in need thereof, comprising:

administering to the lungs of the patient a pharmaceutical composition comprising about 500 mg to about 650 mg amikacin, or a pharmaceutically acceptable salt thereof, encapsulated in a plurality of liposomes, wherein the lipid component of the plurality of liposomes consists of dipalmitoylphosphatidylcholine (DPPC) and cholesterol,

wherein administering to the lungs of the patient comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free amikacin, or a pharmaceutically acceptable salt thereof, and liposomal complexed amikacin, or a pharmaceutically acceptable salt thereof, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient once daily in a single dosing session, for an administration period of at least 6 months,

wherein the treating comprises achieving a negative MAC sputum culture in the patient.

2 . The method of claim 1 , wherein the patient is previously unresponsive to an American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) MAC guideline-based therapy (GBT).

3 . The method of claim 2 , wherein the patient is previously unresponsive to the GBT for at least 6 months.

4 . The method of claim 1 , wherein the patient has a non-cystic fibrosis underlying lung disease.

5 . The method of claim 1 , wherein the method further comprises administering a macrolide antibiotic to the patient.

6 . The method of claim 5 , wherein the macrolide antibiotic is azithromycin, clarithromycin, erythromycin, carbomycin A, josamycin, kitamycin, midecamycin, oleandomycin, solithromycin, spiramycin, troleandomycin, tylosin, roxithromycin, or a combination thereof.

7 . The method of claim 5 , wherein the macrolide antibiotic is azithromycin or clarithromycin.

8 . The method of claim 1 , wherein the method further comprises administering a rifamycin compound to the patient.

9 . The method of claim 8 , wherein the rifamycin compound is rifampin or rifabutin.

10 . The method of claim 1 , wherein the pharmaceutical composition comprises from about 550 mg to about 625 mg amikacin, or pharmaceutically acceptable salt thereof.

11 . The method of claim 1 , wherein the amikacin or pharmaceutically acceptable salt thereof is amikacin sulfate.

12 . The method of claim 1 , wherein the plurality of liposomes comprises unilamellar vesicles, multilamellar vesicles, or a mixture thereof.

13 . The method of claim 1 , wherein the pharmaceutical composition comprises about 70 mg/mL amikacin; about 30 to about 35 mg/mL DPPC; and about 15 to about 17 mg/mL cholesterol.

14 . The method of claim 13 , wherein the pharmaceutical composition further comprises about 1.5% NaCl.

15 . The method of claim 14 , wherein the pharmaceutical composition has a pH of about 6.5.

16 . The method of claim 1 , wherein during the single dosing session, the aerosolized pharmaceutical composition is administered in less than about 15 minutes.

17 . The method of claim 1 , wherein during the single dosing session, the aerosolized pharmaceutical composition is administered in about 10 minutes to about 14 minutes.

18 . The method of claim 1 , wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein the MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures.

19 . The method of claim 5 , wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein the MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures.

20 . The method of claim 8 , wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein the MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2025
From: EAGLE, GINA; GUPTA, RENU
To: INSMED INCORPORATED
Reel/Frame 071955/0634 →
Continuity (11)
Continuation 17845688 · Jun 21, 2022
Continuation 17031744 · Sep 24, 2020
Continuation 16778506 · Jan 31, 2020
Continuation 16515303 · Jul 18, 2019
Continuation 16250476 · Jan 17, 2019
Continuation 15311488
Provisional Application 62056296 · Sep 26, 2014
Provisional Application 62048068 · Sep 9, 2014
Provisional Application 62042126 · Aug 26, 2014
Provisional Application 61993439 · May 15, 2014
Related Publication 20250057863A1 · Feb 20, 2025
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