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Clinical Trials

Aradigm gets NIH grant for Linhaliq in pulmonary non-tuberculous mycobacteria treatment

Published 16 August 2017

The National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) have awarded a Small Business Initiative Research (SBIR) grant to Aradigm to study the treatment of two pulmonary non-tuberculous mycobacteria (PNTM) infections, Mycobacterium avium and Mycobacterium abscessus, with the company’s inhaled liposomal ciprofloxacin products Linhaliq and Lipoquin.

The Principal Investigator is Dr. James D. Blanchard, Principal Scientist, Preclinical Development at Aradigm. Professor Luiz Bermudez at Oregon State University, Corvallis, will lead the laboratory research as a part of the consortium funded by this two year grant of approximately $972,000.

According to a report from NIH based on an epidemiological study in U.S. adults aged 65 years or older, PNTM infections are an important cause of morbidity among older adults in the United States. From 1997 to 2007, the annual prevalence significantly increased from 20 to 47 cases per 100,000 persons, or 8.2% per year.

Forty-four percent of PNTM-affected people in the study had bronchiectasis compared to 1% in the non-PNTM cases, pointing to an important co-morbidity. PNTM infections are common also in patients with other chronic lung conditions, such as cystic fibrosis and emphysema.

The Phase II SBIR grant builds upon the encouraging results demonstrated in the Phase I SBIR grant that found both Linhaliq and Lipoquin to have significant efficacy against M. avium complex and M. abscessus infection. The current standard of treatment of mycobacterial infections is the simultaneous use of multiple antibiotics, and the Phase II grant will focus on combination therapies.

For M. avium complex infection, the efficacy of Linhaliq and Lipoquin will be tested in combination with clarithromycin, ethambutol, and amikacin using macrophage and biofilm test systems as well as a mouse lung infection. For M. abscessus infection, the efficacy of Linhaliq and Lipoquin will be tested in combination with linezolid and imipenem. The emergence of antibiotic resistance will be investigated.

“Pulmonary infections with non-tuberculous mycobacteria (NTM) have become a serious growing public health problem in the U.S. and many other countries as they can result in debilitating lung disease and are costly to treat. We have shown that lung-delivered liposomal ciprofloxacin is effective in in vitro and animal models of NTM without causing the emergence of resistant NTM. Patients with NTM at present typically have to use several antibiotics to avoid the emergence of resistance. This NIH grant is important as it enables us to compare the benefits of lung-delivered liposomal ciprofloxacin alone or in combination with other antibiotics,” said Prof. Bermudez.

“Bronchiectasis and chronic lung infections with Pseudomonas aeruginosa and NTM are frequent co-morbidities. It is our goal to deliver a much needed new treatment for these patients with severe lung diseases,” said Dr. Blanchard.

Source: Company Press Release