MannKind Corporation announced today that a Phase 1 study of MNKD-101 clofazimine demonstrated that the inhalation suspension was well tolerated at doses up to 90 mg/day over 7 days and identified no safety issues. The company is developing MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung disease. According to MannKind, the FDA has granted both orphan drug and QIDP designation to MNKD-101 for the treatment of NTM lung infections.
The MKC-CI -001 SAD/MAD study enrolled 24 healthy volunteers in the SAD portion and 16 in the MAD portion of the study. The SAD portion evaluated single 30 mg, 60 mg or 90 mg doses of clofazimine. In the MAD portion, subjects got either a 30 mg dose or a 90 mg dose of inhaled clofazimine once a day for 7 days.
MannKind CEO Michael Castagna commented, “There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease. As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients.”
Chief Scientific Officer Thomas Hofmann said, “The safety and tolerability results for inhaled clofazimine are encouraging and we look forward to advancing the nebulized formulation of clofazimine to the next phase of development. Clofazimine presented as being very lipophilic and demonstrated the expected therapeutic plasma concentrations we were targeting. In future studies, we plan to evaluate the potential for MNKD-101 to produce drug levels that exceed the minimum inhibitory concentration in the lung beyond the treatment period.”
Read the MannKind Corporation press release.
