Bayer’s Amikacin Inhale has failed to meet the primary end point in a global phase III clinical study program.
Amikacin Inhale is the development name of an integrated drug-device combination, which includes specially formulated Amikacin inhalation solution and Nektar Therapeutics’ advanced synchronized inhalation system with a vibrating mesh nebulizer.
Amikacin Inhale is said to achieve aerosol delivery of around 50% of the nominal dose into the lungs.
Inhale is a multinational, randomized, placebo-controlled, double-blind, multi-centre study program, which evaluated the clinical efficacy and safety of Amikacin Inhale in combination with standard of care over IV standard of care and aerosolized placebo to treat Gram-negative pneumonia in adult patients who are intubated and mechanically ventilated.
The trial did not showed superiority against standard of care and aerosolized placebo.
The primary endpoint and secondary endpoints were similar in both treatment arms, indicating that the trial did not meet the primary end point.
Inhale program, which included 725 patients, randomized the patients into two arms. Patients in the first secured 400mg of aerosolized amikacin every 12 hours for 10 days administered using the synchronized inhalation system.
Patients secured aerosolized placebo every 12 hours for 10 days in the comparator arm with the support of synchronized inhalation system.
Bayer pharmaceutical division executive committee member and development head Dr Joerg Moeller said: “The results of the Inhale study are disappointing, considering that morbidity and mortality remain significant in these patients. However, the study provides important clinical data for this difficult-to-treat disease.”
Image: Bayer’s pharmaceuticals division headquarters in Berlin, Germany. Photo: courtesy of Bayer.