Bayer and Nektar report positive results from Phase II pneumonia trial

In the multi-center, randomized, double-blind, placebo-controlled Phase II study mechanically ventilated patients (MVP) received 400 mg doses of amikacin with Amikacin Inhale every 24 hours (n=24) or every 12 hours (n=21) for 7-14 days. This study evaluated Amikacin Inhale penetration into the fluid lining of the epithelial surface (ELF) of the lower respiratory tract of the pneumonia-infected lung. Treatment was adjunctive to IV treatment.

Amikacin Inhale achieved over 1000 times greater lung exposure to the antibiotic amikacin as compared to intravenous route of administration. The results show that targeting antibiotic therapy to the site of infection might offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of the patient’s survival.

The delivery of aerosolized Amikacin Inhale achieved high aminoglycoside amikacin concentrations in the ELF of the lower respiratory tract, including in the pneumonic area of the lung while maintaining safe serum concentrations. Median ELF levels were 976.1mcg/mL [135.7-16,127.6], always exceeding the amikacin minimum inhibitory concentration for microorganisms usually responsible for Gram-negative pneumonia.

Amikacin Inhale will enter Phase III trials later this year to further assess its efficacy and safety in mechanically ventilated patients with Gram-negative pneumonia. The enrolment for two pivotal Phase III studies will start in the fourth quarter of 2008.