Arikayce (also known as liposomal amikacin for inhalation, or LAI) is being developed by Insmed as a possible inhalation treatment for serious lung conditions, such as bronchiectasis. Arikayce consists of liposomes that contain amikacin, an antibiotic used to treat severe or serious bacterial infections.
Liposomes are microscopic phospholipid spheres that contain water. In a treatment such as Arikayce, amikacin — a water-soluble antibiotic — is enclosed inside the liposome. Insmed’s liposomal technology is designed to deliver amikacin directly to the lungs for immediate treatment, and to maintain the antibiotic locally in the lungs over time.
What is amikacin?
Amikacin is an aminoglycoside antibiotic that works by interrupting bacterial protein synthesis after binding to the bacteria. Amikacin is used to treat infections that involve aerobic, gram-negative bacteria and mycobacteria, the bacteria that cause tuberculosis, which can lead to serious lung complications in people with bronchiectasis.
In recent years, non-tuberculosis mycobacterium pulmonary disease (NTM-PD) has come to represent a high risk in terms of its incidence, prevalence, hospitalization rate and mortality rate, and people with chronic pulmonary conditions like bronchiectasis are particularly susceptible. NTM-PD symptoms often overlap with those of the underlying disease, so that NTM-PD is often diagnosed at a later stage. Treatments that might address this disease, especially at earlier stages, are of growing interest.
A Phase 2 study (NCT01315236) assessed the efficacy, safety, and tolerability of Arikayce, versus placebo, in about 90 people with chronic NTM-PD who failed to respond to standard antibiotics. Treated patients were given 590 mg of the inhalation therapy, once daily, for 84 days. Trial results showed Arikayce to treat people with Mycobacterium avium complex infection but the treatment was not superior to placebo for those patients with Mycobacterium abcessus infection.
Insmed has an ongoing Phase 3 study CONVERT (NCT02344004) evaluating about 350 people with drug-resistant NTM-PD, and expects to release topline data in the second half of 2017. The trial’s primary goal is the proportion of patients who achieve different cultures of bacteria after six months of treatment with Arikayce plus a standard regimen of anti-mycobacterial medications, compared to those treated with the standard regimen alone.
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