Insmed, Inc., recently announced that three abstracts related to Arikayce, its drug candidate to treat nontuberculous mycobacteria (NTM) lung disease, and one related to its treprostinil prodrug, will be presented at the American Thoracic Society (ATS) 2016 International Conference taking place in San Francisco on May 13–18. The presentations will cover clinical trial findings for Arikayce, and preclinical studies into a number of treprostinil prodrugs being developed for rare pulmonary disorders, including pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
Arikayce (liposomal amikacin for inhalation) is in late-stage development for the treatment of adults with NTM, a rare and potentially fatal lung disease that now has no approved, specifically indicated medications in the United States, Canada or the European Union (EU). Insmed has filed an EU marketing authorization application, seeking approval for Arikayce in NTM patients.
NTM can become chronic and require continuous treatment, significantly affecting a patient’s quality of life. According to the American Lung Association, there are approximately 50,000 to 90,000 people with NTM pulmonary disease in the United States, with the disease affecting older adults with a much higher frequency.
The company’s early pipeline of products includes several treprostinil prodrugs, such as the nebulized formulation INS1009, which may have therapeutic potential for a range of pulmonary disorders, such as PAH, IPF, sarcoidosis, and severe refractory asthma. The drug is designed as an inhalation suspension of the product hexadecyl-treprostinil. In vitro and in vivo studies have shown that the product, once deposited in the lungs, is converted by lung esterases into the active drug treprostinil. This formulation optimizes the drug’s retention in nanoparticles and potentially allows for 24-hour dosing. If successful in clinical development, the drug can offer PAH patients a more convenient dosing regimen than those currently available, which rely on multiple-dosing regimens throughout the day.
Study data on the potential treatments will be released after the conference presentations. A complete list of Insmed presentations at ATS 2016 was given in a press release and is also available through the conference website. Of note, Dr. Adam Plaunt will talk about pulmonary hypertension in a poster, titled “Structure dependent PK profiles of alkyl ester treprostinil prodrugs (TPD) administered via metered dose inhaler to rats.”