Phase III study with Amikacin Inhale in intubated and mechanically ventilated patients with Gram-negative pneumonia does not meet primary endpoint of superiority

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Nov 24, 2017, 01:30 ET

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 patients^1,2," 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).

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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.

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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

SOURCE Bayer