WHIPPANY, N.J., Nov. 24, 2017 /PRNewswire/ -- Bayer today
announced that INHALE, a global Phase III clinical study program
investigating Amikacin Inhale in addition to standard of care in
intubated and mechanically ventilated patients with Gram-negative
pneumonia, did not demonstrate superiority versus standard of care
plus aerosolized placebo. The primary endpoint, as well as
secondary endpoints were similar in both treatment arms, and were
therefore not met. Amikacin Inhale is the development name of an
integrated drug-device combination, consisting of a specially
formulated Amikacin Inhalation Solution and a proprietary
Synchronized Inhalation System with a vibrating mesh nebulizer.
The primary outcome measure was survival at day 28-32. Secondary
outcome measures included pneumonia-related mortality through to
day 28-32, early clinical response up to day 10, number of days on
mechanical ventilation up to day 28-32, and number of intensive
care unit (ICU) days up to day 28-32. Efficacy and safety analyses
from this study will be published in due course.
"New treatment options are needed for difficult-to-treat
Gram-negative pneumonia in intubated and mechanically ventilated
patients in the intensive care unit setting, as morbidity and
mortality remain significant in these patients1,2," said
Aleksandra Vlajnic, M.D., Vice
President of Medical Affairs at Bayer.
About Amikacin Inhale
Amikacin Inhale (BAY
41-6551) is the development name for an investigational
integrated drug-device combination product, in development by
Bayer, comprised of a specially formulated Amikacin Inhalation
Solution with Nektar Therapeutics' (NKTR) proprietary Synchronized
Inhalation System. Amikacin Inhale was studied in the INHALE phase
3 clinical trial program, in combination with standard of care IV
antibiotics for the treatment of intubated and mechanically
ventilated patients with Gram-negative pneumonia.
About the Phase III program INHALE
The global
INHALE program is a multinational, randomized, placebo-controlled,
double-blind, multi-center study program which investigated the
clinical efficacy and safety of Amikacin Inhale in combination with
standard of care IV antibiotics over standard of care IV
antibiotics and aerosolized placebo for the treatment of
Gram-negative pneumonia in adult patients who are intubated and
mechanically ventilated.
The program included 725 patients. Eligible patients were
randomized into 2 arms. Patients in the first arm received 400 mgs
of Amikacin Inhale (BAY 41-6551) every 12 hours for 10 days
administered using the Synchronized Inhalation System. Patients in
the comparator arm received aerosolized placebo every 12 hours for
10 days, also administered using the using the Synchronized
Inhalation System. Both groups received standard of care IV
antibiotics following American Thoracic Society (ATS) guidelines or
local guidelines.
The Amikacin Inhale program is being developed through a
collaboration with Nektar Therapeutics (NASDAQ: NKTR).
Bayer: Science For A Better Life
Bayer is a global
enterprise with core competencies in the Life Science fields of
health care and agriculture. Its products and services are designed
to benefit people and improve their quality of life. At the same
time, the Group aims to create value through innovation, growth and
high earning power. Bayer is committed to the principles of
sustainable development and to its social and ethical
responsibilities as a corporate citizen. In fiscal 2016, the Group
employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted
to EUR 2.6 billion, R&D expenses
to EUR 4.7 billion. These figures
include those for the high-tech polymers business, which was
floated on the stock market as an independent company named
Covestro on October 6, 2015. For more
information, go to www.bayer.us.
© 2017 Bayer
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Media Contacts:
David
Patti, +1-973-452-6793
Bayer, Product Communications
david.patti@bayer.com
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news release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer Group or subgroup
management. Various known and unknown risks, uncertainties and
other factors could lead to material differences between the actual
future results, financial situation, development or performance of
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to conform them to future events or developments.
For U.S. Media Only
1 Ibrahim EH et al., "Experience with a clinical
guideline for the treatment of ventilator-associated pneumonia,"
Critical Care Medicine, vol. 29, pp. 1109-15, 2001.
2 American Thoracic Society and the Infectious Diseases
Society of America. Guidelines for the management of adults with
HAP, VAP, HCAP. Am J Respir Crit Care Med 2005;171:388-416
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