According to MannKind Corporation, the United States Patent and Trademark Office (USPTO) has issued US patent No. 11,793,808 (“Compositions of Clofazimine, Combinations Comprising Them, Processes for Their Preparation, Uses and Methods Comprising Them”), which covers the company’s MNKD-101 clofazimine inhalation suspension, until 2039. MannKind is developing MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung infections.
MNKD-101 has received both orphan drug and qualified infectious disease product (QIDP) status for the treatment of pulmonary NTM infections. In January 2023, MannKind announced that it would advance MNKD-101 into a Phase 2/3 study in patients with NTM lung infections; however, in June 2023, the company said that the trial would be delayed due to a fire in the facility that was manufacturing clinical trial supplies.
MannKind CEO Michael Castagna commented, “We believe this patent represents important protection for our lead pipeline asset, MNKD-101, that could potentially improve therapy for a disease that is increasingly on the rise globally. Patients living with NTM typically rely on a series of drug treatments that often may be associated with severe side effects. Early data for MNKD-101 is promising as it suggests rapid and targeted delivery of clofazimine deep into the lung has the potential to be better tolerated.”
Read the MannKind Corporation press release.
