clofazimine inhalational (MNKD-101) / MannKind - LARVOL DELTA

MannKind Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Requested meeting with the U.S. Food and Drug Administration ('FDA') in 1H 2025 to discuss data submission for potential approval of Afrezza in the pediatric population. Expect twelve-month data set with safety extension in 1H 2025. Anticipate supplemental new drug application filing in 1H 2025 pending FDA feedback. Clofazimine Inhalation Suspension Phase 3 (ICON-1) global clinical trial (MNKD-101)...Expect to meet the interim enrollment target by YE 2025....Nintedanib DPI Phase 1 clinical trial (MNKD-201)...Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into next phase of development..."

Enrollment status • FDA event • Idiopathic Pulmonary Fibrosis • Nontuberculous Mycobacterial Disease • Type 2 Diabetes Mellitus

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension (clinicaltrials.gov) - P3 | N=234 | Recruiting | Sponsor: Mannkind Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Nontuberculous mycobacteria • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension (clinicaltrials.gov) - P3 | N=234 | Not yet recruiting | Sponsor: Mannkind Corporation

New P3 trial • Nontuberculous mycobacteria • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy Volunteers (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: MannKind Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy Volunteers (ANZCTR) - P1 | N=40 | Not yet recruiting | Sponsor: MannKind Corporation

New P1 trial • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Outcomes of inhaled amikacin-containing multidrug regimens for Mycobacterium abscessus pulmonary disease. (PubMed, Chest) - P=N/A | "Inhaled amikacin with or without clofazimine in the regimen provides favorable treatment outcomes in M. massiliense-PD. However, more effective treatments are needed for M. abscessus-PD."

Journal • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Clofazimine inhalation suspension for the aerosol treatment of pulmonary nontuberculous mycobacterial infections. (PubMed, J Cyst Fibros) - "Clofazimine inhalation suspension is a well tolerated and effective novel therapeutic candidate for the treatment of NTM infections in mouse models."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Outcomes of Inhaled Amikacin and Clofazimine-Containing Regimens for Treatment of Refractory Mycobacterium avium Complex Pulmonary Disease. (PubMed, J Clin Med) - "Inhaled AMK with CFZ may provide favorable outcomes in some patients with refractory MAC-PD. However, given the adverse effects, more effective strategies are needed to maintain these therapeutic regimens."

Journal • Respiratory Diseases

[VIRTUAL] Single and Repeated Dose Pharmacokinetics of QRM-003 in Rodent Models (ATS-I 2020) - "Rationale : Nontuberculous mycobacterial pulmonary disease (NTM-PD) is rapidly increasing in prevalence worldwide, with few treatments available. We anticipate that the pulmonary retention of clofazimine following inhalation will result in lower extrapulmonary tissue accumulation, i.e. subcutaneous fat and small intestinal tissue, which are the main sites of clofazimine adverse events. Additional studies are ongoing to evaluate drug distribution to these tissues following inhaled delivery, and to compare extrapulmonary exposure following oral vs. inhaled clofazimine delivery."

PK/PD data • Preclinical • Respiratory Diseases

Single and Repeated Dose Pharmacokinetics of QRM-003 in Rodent Models (ATS 2020) - "Following inhalation, QRM-003 led to significant deposition and retention of clofazimine within the lung tissue, with a long half-life. We anticipate that the pulmonary retention of clofazimine following inhalation will result in lower extrapulmonary tissue accumulation, i.e. subcutaneous fat and small intestinal tissue, which are the main sites of clofazimine adverse events. Additional studies are ongoing to evaluate drug distribution to these tissues following inhaled delivery, and to compare extrapulmonary exposure following oral vs."

PK/PD data • Preclinical