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Also known as LAI, ARIKAYCE™
LAI plus multi-drug regimen · 3 trials · 3 indications
TEAEs are defined as those AEs that occurred on or after the date of first dose of study medication in INS-312 and within 28 days after the last dose. If it couldn't be determined whether the AE is treatment emergent due to a partial onset date, then it was classified as treatment emergent.
Sputum specimens were collected at Screening (Visit 1), Baseline (Visit 2), and at Visits 3 (Month 1) through 8 (Month 6). A negative culture result reflected a negative culture result for all sputum samples collected at each visit. Participants met the primary endpoint of culture conversion by Month 6 if they had 3 consecutive monthly MAC-negative sputum cultures during the first 6 months of the study. A participant needed to achieve the first of 3 consecutive negative sputum cultures (that defined culture conversion) by Month 4 in order to meet the primary endpoint by Month 6. Each participant in the intent to treat (ITT) population (ie, all randomized participants) was classified as either a converter or non-converter by Month 6.
Sputum specimens were collected at screening, baseline (Day 1), during treatment, and at Months 1, 3, 6, and 12 months off treatment. Culture conversion with durability was defined as achieving culture conversion by Month 6 and then having no more than 2 consecutive broth positive cultures and no Agar positive culture up to 3 months off treatment. Converters with missing broth or Agar sputum culture result after Month 6 up to 3 months off treatment were considered as not achieving culture conversion with durability except those participants who are unable to produce sputum despite reasonable efforts, as reported by source documentation. Participants who had relapse/recurrence, had "rescue" medication and/or died before reaching 3 months off treatment were considered as not achieving culture conversion with durability.
| Arm | Type | Description |
|---|---|---|
| Prior LAI + Multidrug Regimen | EXPERIMENTAL | Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR. |
| Prior Multidrug Regimen Alone | EXPERIMENTAL | Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR. |
| Multi-drug Regimen | NO_INTERVENTION | Participants received their already prescribed anti-mycobacterial regimen (based on the 2007 American Thoracic Society/Infectious Diseases Society of America \[ATS/IDSA\] Guidelines) |
| LAI + Multi-drug Regimen | EXPERIMENTAL | Participants received LAI 590 mg QD in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines) LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes |
| LAI plus multi-drug regimen | EXPERIMENTAL | once daily dosing of Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC) mycobacterial multi-drug regimen in accordance with the 2007 ATS/ IDSA guidelines |
| Name | Type | Description |
|---|---|---|
| LAI 590 mg | DRUG | LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes |
| Multi-drug regimen | DRUG | Multidrug antimycobacterial regimen from study INS-212 |
| LAI (Liposomal Amikacin for Inhalation) 590 mg | DRUG | LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes. |
| LAI plus multi-drug regimen | DRUG | Liposomal Amikacin for Inhalation (LAI) is the experimental treatment which, in this single arm will be taken in conjunction with standard of care multi-drug treatment regimen |
Key Inclusion Criteria: 1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212 2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212. Key Exclusion...
LAI plus multi-drug regimen refers to liposomal amikacin for inhalation (LAI) 590 mg added to a standard multi-drug antibiotic regimen for nontuberculous mycobacterial (NTM) lung infection, including infection caused by Mycobacterium avium complex (MAC). It is an investigational inhaled small molecule developed by Insmed Incorporated.
It is being studied for NTM lung infection due to Mycobacterium avium complex (MAC) and other nontuberculous mycobacterial infections. The approach adds inhaled LAI 590 mg to a background multi-drug regimen, with the goal of improving treatment for these difficult-to-treat lung infections.
Insmed Incorporated (ticker INSM) is developing LAI, also known as liposomal amikacin for inhalation 590 mg, for NTM lung infection. The company sponsors the clinical program evaluating LAI added to a multi-drug regimen.
LAI plus multi-drug regimen has been evaluated in Phase 3 clinical development. It is investigational and has not been approved by the FDA for NTM lung infection. The program includes completed Phase 3 trials, including the study of LAI added to a multi-drug regimen versus a multi-drug regimen alone.
Key trials include NCT02344004, a Phase 3 study evaluating LAI added to a multi-drug regimen compared with a multi-drug regimen alone, and NCT02628600, an open-label Phase 3 safety extension study for patients who participated in study INS-212. A Phase 2 study, NCT03038178, evaluated LAI in Mycobacterium abscessus lung disease.