Amikacin Inhale (NKTR-061)

Amikacin Inhale (NKTR-061)

Indication: Gram-negative pneumonia

Discovered by Nektar

Partner
Partner

Phase 3


Amikacin Inhale, also known as BAY41-6551 (NKTR-061), is a drug-device combination product under development by Nektar and Bayer, as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. Gram-negative pneumonias are often the result of complications of other patient conditions or surgeries. Gram-negative pneumonia can account for up to 85% of the hospital-acquired pneumonias and are especially prevalent in intensive care units.1

Amikacin Inhale Clinical Data and Profile

Amikacin Inhale will be adjunctive therapy to the current antibiotic therapies administered intravenously as the standard of care. The Amikacin Inhale device can be integrated with conventional mechanical ventilators or used as a hand-held ''off-vent'' device for patients no longer requiring breathing assistance.

Phase 2 clinical data for Amikacin Inhale shows that patients achieved over 1,000 times greater lung exposure to the antibiotic amikacin with NKTR-061 than the IV route of administration. Targeting the antibiotic therapy to the site of infection could offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of survival.2

The product can be integrated with conventional mechanical ventilators or used as a hand-held ''off-vent'' device for patients no longer requiring breathing assistance.

Phase 2 clinical data for Amikacin Inhale shows that patients achieved over 1,000 times greater lung exposure to the antibiotic amikacin with NKTR-061 than the IV route of administration. Targeting the antibiotic therapy to the site of infection could offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of survival.

About the Phase 3 INHALE Study Program

The global INHALE study program is comprised of two prospective, randomized, double-blind, placebo-controlled, multicenter studies to evaluate the safety and efficacy of BAY41-6551 as adjunctive therapy in intubated and mechanically-ventilated patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The study will enroll patients age 18 or above who have microbiologically-confirmed pneumonia caused by Gram-negative organisms. INHALE will be a large multi-center global program involving centers in North America, South America, Europe, Japan, Australia and Asia. For more information about the trial, please visit www.clinicaltrials.gov

References

1 American Thoracic Society, "Guidelines for the Management of Adults with Hospital-acquired, Ventilator-associated, and Healthcare-associated Pneumonia," Am J Respir Crit Care Med, vol. 171, pp. 388-416, 2005.

2 Kadrichu N, et al., In vitro Efficiency of the Amikacin Inhale System, a novel integrated drug-device delivery system, Poster A384, International Symposium on Intensive Care and Emergency Medicine, March 19-22, 2013


ISICEM 2013 — International Symposium on Intensive Care and Emergency Medicine

Manuscript: Critical Care 2009

2008 American Thoracic Society Annual Meeting

2007 American Thoracic Society Annual Meeting