MannKind Corporation said that it will advance MNKD-101 clofazimine to a Phase 2/3 study following positive results from a Phase 1 trial of the inhalation suspension delivered via jet nebulizer. The FDA has granted both orphan drug and QIDP designation to MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung infections. The company also announced the publication of data from preclinical studies of the inhaled formulation in the journal Antimicrobial Agents and Chemotherapy.
MannKind CEO Michael Castagna said, “NTM lung disease typically translates to prolonged oral drug treatments used off label that often result in high systemic toxicity and serious side effects. We are encouraged by the preclinical and Phase 1 data, and how inhaled clofazimine may finally resolve these issues, and most importantly, provide patients with a potentially improved NTM therapy.”
Chief Scientific Officer Thomas Hofmann added, “We are pleased to observe that in the preclinical model, our drug concentration in the lung remained well above the average NTM MIC when dosed for 28 days followed by a 56-day drug holiday. The demonstrated tolerability and lung loading capability of inhaled clofazimine has been impressive and confirmed in the Phase 1. We are now looking forward to studying this investigational formulation for efficacy and safety in an NTM patient population.”
Read the MannKind Corporation press release.
Read the Antimicrobial Agents and Chemotherapy article.
