Mannkind IND Clearance - Phase III NTM
Apr 29, 2024 5:09:58 GMT -5
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Post by hellodolly on Apr 29, 2024 5:09:58 GMT -5
MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial (NTM) lung disease.
“Oral clofazimine has been utilized as a treatment option for patients living with NTM lung disease and we believe that by reducing the dose and administering it directly to the lung we can demonstrate improved dosing, tolerability and safety,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Advancing this program to a Phase 3 trial, we are encouraged that MNKD-101 could potentially address a serious unmet need that is on the rise globally – particularly in the U.S. and the Asia Pacific region.”
This single registrational study, identified as ICoN-1, anticipates getting underway by end of 2Q 2024 in the U.S., and internationally in the second half of 2024. ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by Mycobacterium Avium Complex (MAC), followed by an open-label extension.
“Current regimens for patients living with NTM lung disease require the use of multiple medications that are often associated with significant adverse reactions and safety concerns, prolonged periods of administration, and suboptimal outcomes both short-term and long-term,” said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer of MannKind Corporation. “Patients living with NTM deserve safe, well-tolerated, convenient, and effective options to treat this serious respiratory disease.”
Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide, association with shortened life span and significant impact on patients’ daily living. NTM is a group of bacteria naturally found in our environment, including water and soil, that can lead to cough, fatigue, a reduction in lung function, and poor quality of life. While most people are exposed to NTM daily, the organisms generally do no harm. Individuals with underlying conditions such as COPD, asthma, and bronchiectasis are prone to NTM getting established in the lungs creating an infection and progressive worsening of lung function.
NTM lung disease is more common in women over the age of 65, with a predominance in those of Caucasian and Asian descent. In 2022, there were approximately 122,000 and 159,000 patients living with NTM in the U.S. and Japan, respectively, with as much as 20% of those cases being refractory. The disease state is on the rise, with an estimated annual growth rate averaging 8%.
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial (NTM) lung disease.
“Oral clofazimine has been utilized as a treatment option for patients living with NTM lung disease and we believe that by reducing the dose and administering it directly to the lung we can demonstrate improved dosing, tolerability and safety,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Advancing this program to a Phase 3 trial, we are encouraged that MNKD-101 could potentially address a serious unmet need that is on the rise globally – particularly in the U.S. and the Asia Pacific region.”
This single registrational study, identified as ICoN-1, anticipates getting underway by end of 2Q 2024 in the U.S., and internationally in the second half of 2024. ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by Mycobacterium Avium Complex (MAC), followed by an open-label extension.
“Current regimens for patients living with NTM lung disease require the use of multiple medications that are often associated with significant adverse reactions and safety concerns, prolonged periods of administration, and suboptimal outcomes both short-term and long-term,” said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer of MannKind Corporation. “Patients living with NTM deserve safe, well-tolerated, convenient, and effective options to treat this serious respiratory disease.”
Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide, association with shortened life span and significant impact on patients’ daily living. NTM is a group of bacteria naturally found in our environment, including water and soil, that can lead to cough, fatigue, a reduction in lung function, and poor quality of life. While most people are exposed to NTM daily, the organisms generally do no harm. Individuals with underlying conditions such as COPD, asthma, and bronchiectasis are prone to NTM getting established in the lungs creating an infection and progressive worsening of lung function.
NTM lung disease is more common in women over the age of 65, with a predominance in those of Caucasian and Asian descent. In 2022, there were approximately 122,000 and 159,000 patients living with NTM in the U.S. and Japan, respectively, with as much as 20% of those cases being refractory. The disease state is on the rise, with an estimated annual growth rate averaging 8%.
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