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Combination in treatment of nontuberculous mycobacterial diseases

A mycobacterial, non-tuberculosis technology, used in medical preparations containing active ingredients, antibacterial drugs, organic active ingredients, etc.

Pending Publication Date: 2021-08-17
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No other antibiotics are approved for the treatment of MAC-PD and the above agents are recommended only empirically

Method used

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  • Combination in treatment of nontuberculous mycobacterial diseases
  • Combination in treatment of nontuberculous mycobacterial diseases
  • Combination in treatment of nontuberculous mycobacterial diseases

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0062] Reference example 1. the in vitro activity of bedaquiline

[0063] Bedaquiline is unique in its specificity for mycobacteria, including important atypical species in humans such as M. avium, M. kansasii, and the rapidly growing M. fortuitum and M. abscessus spectrum. M. avium, M. kansasii, and M. abscessus may cause NTM disease.

[0064] The minimum inhibitory concentration (MIC) of bedaquiline against Mycobacterium tuberculosis ranged from ≤0.008 μg / ml to 0.12 μg / ml, regardless of the drug-resistant subtype. Bedaquiline MIC is usually <0.1 μg / ml against other mycobacterial species (including species that are naturally resistant to many other anti-TB agents and are involved in opportunistic infections such as M. avium, M. abscessus) . Mycobacterium fortuitum and Mycobacterium marinum. One isolate each of M. abscessus (0.25 μg / ml) and M. ulcerans (0.50 μg / ml) was found to have a higher MIC compared to M. tuberculosis (see table below). The activity of bedaquiline ...

example 2

[0083] Example 2: In vivo testing

[0084] Purpose

[0085] the main purpose

[0086] The primary objective of this study was to evaluate the effect of bedaquiline amplified cyclic lactone (clarithromycin) and ethambutol (bedaquiline / clarithromycin / ethambutol) in combination with rifamycin amplified cyclic lactone Ester (clarithromycin) versus ethambutol (rifamycin / clarithromycin / ethambutol) in the treatment of NTM-PD in adult patients with refractory NTM-PD due to MAC effect.

[0087] secondary purpose

[0088] Secondary objectives are in adult patients with refractory NTM-PD due to MAC:

[0089] · Assess changes in quantitative sputum colony forming unit (CFU) counts during the 3-month and 6-month treatment periods with:

[0090] Bedaquiline / clarithromycin / ethambutol compared to rifamycin / clarithromycin / ethambutol.

[0091] ·Assess negative sputum culture at 1, 2, 3, 4, 5 months during treatment and at the end of 3-month follow-up after 12 months of treatment.

[00...

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Abstract

The present invention relates to a combination of bedaquiline, a macrolide (e.g. clarithromycin) and, optionally, ethambutol for use in the treatment of a disease associated with nontuberculous mycobacteria (NTM).

Description

technical field [0001] The present invention relates to a combination for use in the treatment of nontuberculous mycobacteria, wherein the combination comprises bedaquiline (such as bedaquiline fumarate, under the trade name marketed), a macrolide (such as clarithromycin or azithromycin) and optionally another component (such as ethambutol) for use in the treatment of non-tuberculous mycobacteria. Other components that may also be part of such combinations include injectable aminoglycosides. Background technique [0002] Non-tuberculous mycobacterial (NTM) lung disease is an important cause of morbidity and mortality in individuals with pre-existing lung conditions such as bronchiectasis and COPD (chronic obstructive pulmonary disease). [0003] Mycobacterium avium tuberculosis complex (MAC), Mycobacterium abscessus (Mab) and Mycobacterium kansasii are the mycobacterial species that cause NTM pulmonary disease (NTM-PD). NTM-PD is distinct from lung infection caused by Myc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/133A61K31/47A61K31/7048A61K31/7052A61K45/06A61P31/04
CPCA61K31/47A61K31/133A61K31/7048A61K31/7052A61K45/06A61P31/04A61K2300/00
Inventor N·罗尼斯A·S·皮姆C·坎比利
Owner JANSSEN PHARMA NV
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