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Method for preventing or treating nosocomial pneumonia

An iatrogenic and pneumonia-related technology, applied in pharmaceutical formulations, chemical instruments and methods, antibody medical components, etc., can solve the problems of complicated management of Pseudomonas aeruginosa infection

Pending Publication Date: 2018-08-03
MEDIMMUNE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, multidrug resistance complicates the management of Pseudomonas aeruginosa infections

Method used

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  • Method for preventing or treating nosocomial pneumonia
  • Method for preventing or treating nosocomial pneumonia
  • Method for preventing or treating nosocomial pneumonia

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0085] Example 1: Phase 1 Clinical Trial Study

[0086] Conduct a Phase 1, first-in-human, randomized, double-blind, placebo-controlled dose-escalation study evaluating the safety and tolerability of single ascending IV doses of MEDI3902 in healthy adult subjects. Among 42 subjects who received MEDI3902 at doses of 250 mg (n=3), 750 mg (n=15), 1500 mg (n=15) or 3000 mg (n=9) and 14 subjects who received placebo , adverse event (AE), PK and ADA data were collected until the last study visit (60 days post-dose / day 61). All AEs in both the MEDI3902 group and the placebo group were Grade 1 or 2 in severity. The most frequently reported adverse events were grade 1 or 2 infusion-related reactions (15 / 42 subjects [35.7%] in the overall MEDI3902 group; none in the placebo group) and grade 1 or 2 headache (across the 6 / 42 subjects [14.3%] in the MEDI3902 group; 2 / 14 subjects [14.3%] in the placebo group). Adverse events of special interest (AESI) included infusion-related reactions ...

example 2

[0089] Example 2: Phase 2b Clinical Trial Study

[0090] Approximately 429 subjects were recruited and administered at approximately 120 sites primarily in Europe in a Phase 2, randomized, double-blind, placebo-controlled, single-dose, dose-ranging proof of concept. Subjects will be randomly assigned in a 1:1:1 ratio to receive a single IV dose of 1500mg or 3000mg MEDI3902 or placebo. The dosing regimen may also become randomized 1:1 between a single IV dose of 1500 mg (or 3000 mg) MEDI3902 or placebo. Randomization will be stratified by geographic region and by whether subjects have received anti-P. aeruginosa antibiotic therapy (duration ≤72 hours) within 96 hours prior to randomization. Subjects will be followed until Day 50 (49 days after study product administration) ( figure 1 ).

[0091]For enrollment, subjects were required to be 18 years of age or older, in an intensive care unit, currently intubated and mechanically ventilated, and expected to remain intubated and...

example 3

[0143] Example 3: MEDI3902 reduces lethality in an acute pneumonia model under lower bacterial burden

[0144] The in vivo effects of MEDI3902 administration were studied in mice using an acute pneumonia model. Groups of mice (n=6) were injected intraperitoneally (IP) with decreasing concentrations of MEDI3902 (1.0 mg / kg, 0.5 mg / kg, or 0.2 mg / kg) or an isotype control IgG antibody (negative control, 0.75 mg / kg). ). Twenty-four hours after treatment, all mice were treated with 2 × 10 5 CFU Pseudomonas aeruginosa strain 6206 (1×LD 100 ) for intranasal infection. Such as image 3 As shown, all control-treated animals died of infection at 120 hours post-infection. However, MEDI3902 showed complete protection at all doses, even at 1×LD 100 The same is true below, suggesting that a lower target serum level of 1.7 μg / mL in humans would provide protection against most Pseudomonas aeruginosa strains.

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Abstract

A method for preventing or treating nosocomial diseases, e.g., diseases caused by Pseudomonas aeruginosa, is provided. The method includes administering to a susceptible human a specified dose of a bispecific antibody that that specifically binds Pseudomonas aeruginosa Psl and PcrV.

Description

[0001] sequence listing [0002] This application contains a Sequence Listing that has been filed electronically in ASCII format and is hereby incorporated by reference in its entirety. The ASCII copy, created on November 17, 2016, is named PSEUD-200-WO-PCT_SL.txt and is 22,415 bytes in size. Background technique [0003] Pseudomonas aeruginosa (P. aeruginosa) is an important iatrogenic pathogen, and pneumonia is one of its most relevant manifestations. Mechanical ventilation is the most important risk factor for nosocomial pneumonia caused by Pseudomonas aeruginosa, and the cumulative risk increases with the prolongation of ventilation time (Zahar, JR, et al. Crit CareMed. 2009Sep; 37(9): 2545- 51 [Zahar, JR, et al. J Critical Care Med. 2009 Sep;37(9):2545-51]). In one study, Pseudomonas aeruginosa accounted for 13% of cases of microbiologically confirmed pneumonia acquired in non-ventilated patients in the intensive care unit (ICU) and 24% of cases of pneumonia in ventilat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H21/04C12P21/08A61K39/00A61K39/104C07K16/00
CPCA61K2039/505C07K2317/21C07K2317/31C07K2317/76C07K16/1214A61P31/04C07K2317/522C07K2317/524C07K2317/526A61K39/40A61K45/06C07K16/468
Inventor H.贾夫里A.迪吉安多梅尼科M.麦卡锡X-Q.于C.K.斯托弗B.毕晓普
Owner MEDIMMUNE LTD
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