Now that the Phase 3 CONVERT study has met its primary endpoint of culture conversion with statistical and clinical significance by Month 6, Insmed said, the company plans to seek priority review and accelerated approval from the FDA for its ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacteria (NTM) lung infections
The randomized, open-label Phase 3 CONVERT study, which enrolled 336 patients, was designed to confirm results from a Phase 2 study that was completed in 2014. CONVERT showed that adding ALIS to standard therapy for NTM lung infections caused by mycobacterium avium complex resulted in no evidence of NTM lung disease at Month 6 for 29% of patients compared to 9% of patients on standard therapy alone.
In 2015, Insmed submitted an MAA for ALIS – then known as Arikayce – based on the Phase 2 data but withdrew the application in June 2016 after the Committee for Medicinal Products for Human Use (CHMP) indicated that the Phase 2 data were insufficient for approval.
Insmed President and CEO Will Lewis said, “We consider these compelling top-line data to be a remarkable accomplishment in a rare disease state with no currently approved therapies. We are particularly encouraged by the consistency of these data when compared with our Phase 2 study results, and look forward to additional data as the CONVERT study continues over the next two years. We want to thank all the patients who participated in this trial around the world as well as the physicians who supported them. Treatment of this serious and potentially debilitating disease is an unmet medical need, and we expect these important data will enable us to submit for accelerated approval.”
Read the Insmed press release.
