After buying in candidate, Mannkind wraps up phase 1 trial of inhaled lung infection prospect

MannKind has wrapped up a phase 1 clinical trial of an inhaled formulation of clofazimine, teeing it up to talk to the FDA about advancing the candidate as a treatment for bacterial lung infections.

Prolonged systemic antibiotics are used to treat nontuberculous mycobacterial (NTM) lung disease, but the regimens are associated with side effects and poor outcomes. MannKind positioned itself to address the unmet medical need late in 2020 when it struck a $12.7 million deal to buy QrumPharma for assets including an inhaled formulation of clofazimine, a drug that is given orally to treat leprosy.

Having wrapped up a phase 1 ascending-dose trial of the clofazimine candidate, code-named MNKD 101, in the second quarter, MannKind has now shared a look at the results and plans for further development. The study found the treatment to be generally well tolerated at doses of up to 90 mg for seven days.

“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,” Thomas Hofmann, M.D., Ph.D., chief scientific officer at MannKind, said in a statement.

Hofmann, who joined MannKind as part of the QrumPharma takeover, called the results “encouraging.” MannKind plans to talk to the FDA about the data and its next steps. Last month, MannKind management targeted the fourth quarter for the preparation of the phase 2 protocol in a presentation to investors. 

MannKind plans to share detailed data at upcoming scientific conferences.