- ICoN-1 study presentation planned November 1 at NTM Symposium Australia
- Study is cleared by health authorities to proceed in Australia, U.S., Japan and South Korea, with Taiwan anticipated by end of year
DANBURY, Conn., Oct. 30, 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 it has initiated its first site for its Phase 3 clinical trial evaluating efficacy and safety of Clofazimine Inhalation Suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease. The study, known as ICoN-1, has been cleared to proceed by the Therapeutic Goods Administration (TGA) in Australia, and by healthcare authorities in three additional countries (U.S., Japan and South Korea) with a fifth (Taiwan) anticipated by end of year.
"With our first site initiation visit (SIV) and regulatory approvals to date in Australia, we are looking forward to enrolling patients for the ICoN-1 study in an effort to further develop a potential therapy for those living with serious NTM lung infections," said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer for MannKind Corporation. "We are encouraged by key opinion leader excitement regarding the prospect of Clofazimine Inhalation Suspension for this growing patient population who struggle with high treatment burden and limited options to address a serious unmet need."
Dr. Wassim Fares, MSc, FCCP, Senior Vice President, Therapeutic Area Head, Orphan Lung Diseases of MannKind will share a presentation and poster for ICoN-1 at The University of Queensland on Friday, November 1, for the NTM Symposium 2024, discussing preclinical research, the phase-1 data, the phase-3 study design, and more.
The ICoN-1 study enrolled its first randomized study participant in September. In all, approximately 230 eligible participants will be enrolled and randomized at more than 100 sites globally to ensure a minimum of 180 participants are evaluable for efficacy. Details of the ICoN-1 study and sites can be found at: ClinicalTrials.gov (NCT06418711).
About the ICoN-1 Clinical Trial The ongoing ICoN-1 trial is a multi-national, randomized, double-blind, placebo-controlled, Phase 3 study 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. The primary endpoint is sputum culture conversion (negative for NTM) from baseline to end of Month 6. In the U.S. there is a co-primary endpoint of change in quality of life (QoL) during the same timeframe.
In May 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Clofazimine Inhalation Suspension (MNKD-101) for the treatment of NTM lung disease. The FDA also previously designated Clofazimine Inhalation Suspension as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. A drug that receives orphan drug exclusivity receives seven years of exclusivity, and one that also earns QIDP designation, may receive an additional five years of market exclusivity.
Clofazimine Inhalation Suspension was granted a patent (No. 11,793,808) by the United States Patent and Trademark Office covering compositions of clofazimine and methods for treating lung infections. The patent is not due to expire until June 8, 2039. A corresponding clofazimine patent was granted in Japan (7377259), and patent applications are pending in Australia and other countries.
About NTM - A Global Health Concern Pulmonary NTM infection is a rare disease with a global health impact due to its rising prevalence worldwide and association with shortened life span, high morbidity, and significant impact on patients' quality of life. 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 among other debilitating symptoms. 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 at increased risk of NTM getting established in the lungs creating an infection and progressive worsening of lung function.
