Medical professionals seeking to treat the serious and growing problem of hospital-acquired gram-negative pneumonia may have a new weapon: NKTR-061 (inhaled-amikacin), which is a product candidate being developed by Nektar Therapeutics.
Results of a phase 2a clinical trial evaluating the use of NKTR-061 (Inhaled Amikacin) to treat mechanically ventilated patients with hospital-acquired gram-negative pneumonia were presented at the annual American Thoracic Society (ATS) International Conference.
"The data in this study are very encouraging because they indicate that the adjunctive use of aerosol antibiotics with systemic therapy might be an effective new approach for treating patients infected by hospital-acquired, gram negative pneumonia, many of whom were infected by resistant gram negative pathogens," said Michael S Niederman, MD, chairman of the department of medicine at the Winthrop-University Hospital and Professor of Medicine at the State University of New York at Stony Brook in Minneola, New York, a lead investigator who presented the data today.
"The key to effectively treating this difficult clinical condition is delivering high concentrations of antibiotics to the site of infection, particularly the pneumonic portions of the lung, and thereby eradicating the pathogens. The findings in the study raise the real possibility that the efficacious delivery of aerosolised antibiotics with the system used in this study can lead clinicians to use less systemic antibiotics, while still achieving clinical success. This in turn may make it possible to avoid further development of antibiotic resistance, which is a serious problem in this patient population."
NKTR-061 (inhaled amikacin) is currently being tested to further evaluate the safety, tolerability, and deep lung concentrations of amikacin formulated for inhalation for the adjunctive treatment of gram-negative pneumonia in ventilated patients diagnosed with hospital or ventilator associated pneumonia. This new inhaled antibiotic product candidate is the first of a series of antibiotic products being developed by Nektar that leverage the Company's proprietary micropump technology to rapidly deliver aerosolised antibiotics to the deep lungs, both within and outside of a ventilator system. Nektar's micropump technology enables rapid, reliable and efficient aerosol delivery that can be deployed in a wide range of ventilators without disturbing or complicating existing settings. The result is a potentially more effective treatment modality that provides key advantages over traditional pneumatic or ultra-sonic nebulizer delivery.
Hospital-acquired, gram-negative bacterial pneumonia is a serious problem that afflicts patients even in the world's most advanced clinical settings. Increasing gram-negative antibiotic resistance has been a problem in the setting of hospital-acquired pneumonia. It is commonly acquired by patients in intensive care units who have been put on ventilators for breathing assistance. Current treatment involves the administration of intensive antibiotics, supplemental oxygen, and mechanical ventilator support. Some 25 per cent to 50 per cent of those who acquire gram-negative bacterial pneumonia will die.