Amikacin Inhale (NKTR-061/BAY41-6551)

Therapeutic Area Nektar
Discovered
Indication Phase Partner
Anti-Infectives  
Amikacin Inhale (NKTR-061)
(BAY41-6551)
Gram-negative pneumonia
Phase 3
Bayer

Market information
Amikacin Inhale, also known as BAY41-6551 or NKTR-061, is under development by Nektar''s partner, 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 Product Profile
Amikacin Inhale is a drug-device combination product, comprised of a specially formulated Amikacin Inhalation Solution with Nektar's Pulmonary Drug Delivery System (PDDS). It is being developed in partnership with Bayer HealthCare. Amikacin Inhale will be adjunctive therapy to the current antibiotic therapies administered intravenously as standard of care. The unique areosolization system, PDDS, was designed to achieve optimal lung penetration of the specially formulated Amikacin Inhale Solution, delivering antimicrobial agent directly to the site of infection in the lungs. Amikacin Inhale can achieve aerosol delivery into the lungs of approximately 50% of the nominal dose2,3,4. This compares favourably to other currently available nebulizers, which deliver 10-20% of the nominal dose to the lungs2.

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 that 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.clincaltrials.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 Dhand R, et al., "Pulmonary Drug Delivery System for inhaltion therapy in mechanically ventilated patients," Expert Rev. Med. Devices, vol. 5 (1), pp. 9-18, 2008.
3 Dhand R, et al., "Aerosol delivery During Mechanical Ventilation: From Basic Techniques to New Devices," Journal of Aerosol Medicine and Pulmonary Drug Delivery, vol. 1, pp. 45-60, 2008.
4 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

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