According to a story from pm360online.com, the biopharmaceutical company Insmed Incorporated recently announced that the data from its Phase 3 clinical trial of amikacin liposome inhalation suspension (ALIS). ALIS was being tested in the study as a treatment for nontuberculous mycobacterial lung disease that was treatment refractory and linked to Mycobacterium avium complex. These results were published in the American Journal of Respiratory and Critical Care Medicine.
About Nontuberous Mycobacterial Lung Disease
Nontuberous mycobacterial lung disease refers to a group of diseases which are connected to infection with mycobacteria. This is an illness in which the severity of symptoms can vary greatly. These bacteria typically do not cause disease, but there are certain factors that can make a person more vulnerable. Immunodeficiencies or other lung diseases, such as bronchiectasis, cystic fibrosis, or COPD increase risk. With that said, some patients get the disease without having any known risk factors. Symptoms include chest pain, heavy mucous production, coughing up blood, wheezing, unexpected weight loss, appetite loss, fatigue, shortness of breath, fever, and night sweats. Nontuberous mycobacterial lung disease can cause permanent lung damage. Treatment often involves long term use of antibiotics, and, in some cases, surgery. Treatment can have tough side effects and there is need for better therapies. To learn more about nontuberous mycobacterial lung disease, click here.
About The Study
This study looked at the addition of ALIS as supplemental to the standard therapeutic approach. As part of this combination, ALIS was able to reduce the detectable elements of the disease in sputum culture in 29 percent of patients after a period of six months. On its own, the standard therapy could only do this at a rate of 8.9 percent. This is a groundbreaking improvement for a patient community that hasn’t seen the opportunity for advancements in treatment in about three decades. The study involved over 300 patients with the disease.
Priority Review
On the whole, side effects were slightly worse with the combination treatment, but only 17.4 percent of patients had to halt their use of ALIS because of treatment related adverse events. At this juncture, ALIS is in the process of Priority Review from the FDA and the agency should reach a decision near the end of September.
