Date: 2013-04-16
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Bayer Healthcare (Germany) Nektar Therapeutics (USA)
Product: Amikacin Inhale (NKTR-061 - BAY41-6551)
Action
mechanism: antibiotic. Targeting aerosolized antibiotics directly to the site of infection with low systemic exposure is a new concept to improve the treatment of Gram-negative pneumonia. Amikacin Inhale (NKTR-061 - BAY 41-6551) is the development name for a drug-device combination product currently being developed as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. It is being developed by Bayer HealthCare and combines amikacin, a broad spectrum aminoglycoside antibiotic and a specially formulated Amikacin Inhalation Solution with Nektar Therapeutics’ proprietary Pulmonary Drug Delivery System (PDDS). Amikacin Inhale has been shown to achieve aerosol delivery of approximately 50% of the nominal dose into the lungs. This compares favourably to other commercially available nebulizers, which deliver 10-20% of the nominal dose to the lungs.
Disease: Gram-negative pneumonia
Therapeutic area: Infectious diseases
Country: USA, Australia, Brazil, Korea, Peru, Taiwan, Thailand, Turkey for INHALE 1 - Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland and UK for INHALE 2
Trial
details: The global INHALE study program is comprised of two prospective, randomized, double-blind, placebo-controlled, multicenter studies (INHALE 1 (NCT01799993) and INHALE 2 (NCT00805168) 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.
Latest
news: * On April 16, 2013, Bayer has announced the successful enrolment of the first patient in a global Phase III program, INHALE, which will evaluate the efficacy and safety of Amikacin Inhale as an adjunctive therapy to the standard of care, intravenous antibiotics, in intubated and mechanically ventilated patients with Gram-negative pneumonia. \"Our primary objective of the program is to demonstrate superior clinical response by using Amikacin Inhale as an adjunctive therapy to standard of care compared to standard of care plus placebo\", said coordinating investigator Jean Chastre, Professor of Medicine, University of Paris, Director of the Medical Intensive Care Unit at the Hôpital Pitié-Salpêtrière in Paris.
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.
The program will include approximately 1,300 patients worldwide. The primary endpoint is the proportion of cured patients in the Amikacin Inhale group compared to the proportion of cured patients in the placebo group. In the study, patients will be randomized into two arms. Patients in the first arm will receive 400 mg of aerosolized amikacin every 12 hours for 10 days administered using the PDDS. In the comparator arm patients will receive aerosolized placebo every 12 hours for 10 days, also administered using the PDDS. Both groups will receive standard of care IV antibiotics in parallel in line with American Thoracic Society (ATS) guidelines.
