Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex

Delpazolid, which demonstrates effects similar to other oxazolidinone-class drugs and has confirmed good safety, aims to evaluate its efficacy in MABC-PD patients who are unresponsive to guideline-based treatments

Inclusion criteria

• Pre-screening: Adults aged 19 years or above
• Pre-screening: Patients diagnosed with MABC (including subspecies abscessus, bolletii, and massiliense) pulmonary disease in radiologic and microbiologic evaluations
• LCB01-0371 MIC ≤ 8 μg/mL for MABC
• Patients who continue to show positivity for MABC even after treatments based on the guidelines of ATS/ERS/ESCMID/IDSA for at least 6 months prior to screening, and who meet all of the following criteria:

• Patients who have been confirmed positive at least once in the last sputum or bronchoscopy sample culture performed prior to screening
• Patients who have not achieved culture conversion (at least 3 consecutive negative mycobacteria cultures in the sputum or bronchoscopy sample collected at an interval of at least 4 weeks) within 6 months prior to screening
• Patients who can voluntarily expectorate sputum at screening
• Patients with a life expectancy of 12 weeks or more
• Patients with adequate organ function who meet the following criteria:

• Hemoglobin > 9.0 g/dL (without transfusion within 2 weeks prior to measurement)
• Absolute neutrophil count ≥ 1,500/µL (without administration of G-CSF within 2 weeks prior to measurement)
• Platelet ≥ 100,000/µL
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 × ULN
• Serum creatinine ≤ 1.5 × ULN or creatinine clearance >30 mL/min (calculated with the Cockcroft-Gault formula)
• Patients who voluntarily provided a written consent to participate in the clinical study

Exclusion criteria

• Patients who cannot swallow the study drug tablet due to dysphagia, nasogastric tube insertion, etc.
• Patients diagnosed with cystic fibrosis
• Patients who have received a lung transplant
• Patients with disseminated or extrapulmonary nontuberculous mycobacteria
• Patients with known active pulmonary tuberculosis
• Patients with NTM infections other than MABC
• Patients with an active pulmonary malignancy within 1 year prior to screening or Patients with other malignancies that require chemotherapy or radiotherapy
• Patients who has received linezolid for MABC treatment within 3 months prior to screening
• Patients with known HIV positivity or a suspected infection thereof or Patients with a known active hepatitis B or C infection
• Patients who currently have a clinically significant cardiovascular disease

• Patients with severe cardiac failure (New York Heart Association [NYHA] class III/IV) that occurred within 24 weeks prior to screening
• Patients with pulmonary embolism or deep venous thrombosis that occurred within 24 weeks prior to screening
• Patients whose multidrug therapy for treatment of MABC was changed within 4 weeks prior to screening (Discontinuation, dose adjustment, change of administration route, etc., are allowed.)
• Patients for whom the administration of contraindicated concomitant drugs that correspond to the following cannot be discontinued during the clinical study or for whom their administration is necessary

• Administration of a new antibacterial agent for the prioritized treatment of NTM, especially MABC, other than background therapy
• Monoamine oxidase inhibitors
• Serotonin reuptake inhibitor or serotonin 5-HT1 receptor agonists
• Meperidine or buspirone
• Drugs that lower epilepsy threshold; tramadol, etc.
• Tricyclic Antidepressant
• Other investigational products: If there is a history of administration within 30 days prior to screening, it falls under the exclusion criteria.
• Pregnant or breastfeeding women and women of childbearing potential who do not agree to practice appropriate contraceptive methods*: